Uloric

Uloric Heart Risk

by with No Comment Drugs

In 2009, Uloric (febuxostat) was the first new drug approved by the FDA for gout in nearly 40 years. Until then, allopurinol (Zyloprim) was the only drug available on the market for preventing the formation of the uric acid crystals that cause gout. However, many patients could not tolerate the recommended therapeutic dose of allopurinol without suffering side effects (sometimes fatal). This new drug did not get overwhelming support by the FDA advisory committee but was ultimately approved.

Clinical Trials for Uloric

Early clinical trials of Uloric showed that at a dose of 80mg, this new drug worked far better than allopurinol and at a 40mg dose, it works equally as well as allopurinol (Clinical Trials, 2005) (Clinical Trials, 2009). Research findings on this drug were submitted with an application to the FDA for approval. The FDA rejected this application sighting that there were slightly more deaths and heart problems with patients taking Uloric than were reported with patients taking allopurinol.

The manufacturer (Takeda) then submitted another application for approval. This 2006 application was denied as well. The committee members noted that 9 of the total 12 deaths among Uloric subjects were attributable to cardiovascular events, whereas no serious adverse cardiovascular (CV) events were linked to allopurinol or the placebo. Taketa then conducted another clinical trial and did not find these same results (Schumacher et al., 2008). They reported that most common side effects seen in these patients were liver function abnormalities, muscle and connective-tissue symptoms, nausea, and rash (FDA Prescribing Info, 2009). The drug was reported as being well tolerated, and the side effects did not increase over long-term use.

The FDA grouped the finding from all of the studies conducted by Takeda and could not determine “with much confidence” that Uloric posed a greater risk of CV events than did allopurinol. They ultimately approved the use of Uloric in the chronic management of hyperuricemia (elevated levels of uric acid) in patients with gout. With this use granted, they also stipulated that the manufacturer (Takeda) was required to conduct additional post-marketing clinical trial to determine:

  1. Whether the use of Uloric is associated with a moderate increase in the risk of serious adverse cardiovascular outcomes when compared to allopurinol.
  2. Any drug-drug interactions with Uloric and a single, oral dose of theophylline.

The results of these clinical trials also needed to be reported to the FDA according to a set schedule. The Final Report Submission for the drug-drug interaction with theophylline was due on May 31, 2010, and the Final Report Submission for cardiovascular risks was due on January 31, 2015 (FDA, 2009). They were also required to include drug warning labels.

Uloric-tab40
Uloric-tab80

Uloric Marketing

According to a report in The Pharma Letter, in the decade since Uloric was approved, the medication has been aggressively marketed to consumers and providers (Pharma Letter, 2018). Takeda reported $1.9 billion in US sales of febuxostat from fiscal years 2012 through 2017. For the one-year period ending in June 2015, there were 1.3 million US prescriptions for Uloric, making it the 46th most prescribed brand-name medication in the USA at the time. The retail price of a 30-day supply of Uloric is also roughly 20-25 times higher than allopurinol when compared on the GoodRx website (3/2019).

Uloric Cardiovascular Concerns

In 2017, serious concerns started to surface about the CV risks associated with the use of Uloric. November of that year, the FDA announced that they had received the preliminary results from the required clinical trials from Takeda and were alerting the public that they showed an increased risk of heart-related death with febuxostat (Uloric) compared to allopurinol. They stated that once the Final Report Submission was received, the information would undergo a comprehensive review. Once that was complete, they would notify the public of any additional findings (FDA, 2017).

The results of the study known as CARES was presented in March 2018, at an annual meeting of the American College of Cardiology in Orlando. This long term study compared the risk of CV events with the use of Uloric to allopurinol. They concluded that the rates were comparable for major CV events (non-fatal heart attack, stroke, rhythm problems and hospitalization for heart failure) between the two drugs (American College of Cardiology, 2018).

Following this announcement, a nonprofit consumer advocacy organization called Public Citizen Health Research Group petitioned the FDA to remove the gout medication Uloric. According to the agency’s director “The FDA almost certainly would have denied approval of febuxostat if data from this post-market trial had been available at the time of the initial submission. The only justifiable course of action to prevent further cardiovascular deaths is obvious: This medication must be removed from the U.S. market immediately.”( Public Citizen, 2018)

In February 2019, the FDA released the results of their advisory committee review. The committee members overwhelmingly voted 19 to 2 (with one abstention) to approve a Boxed Warning for Uloric due to increased risk of heart-related death and death from all causes with the use of this drug. The FDA also stated that providers should “reserve Uloric for use only in patients who have failed or do not tolerate allopurinol. Counsel patients about the cardiovascular risk with Uloric and advise them to seek medical attention immediately if they experience the symptoms” such as:

  • Chest pain
  • Shortness of breath
  • Rapid or irregular heartbeat
  • Numbness or weakness on one side of your body
  • Dizziness
  • Trouble talking
  • Sudden severe headache

Taketa’s View of the CV Risks of Uloric

Taketa’s most recent clinical study of Uloric revealed that there were 15 deaths per year from heart-related causes and 26 deaths per year from any cause per 1,000 patients were observed (FDA, 2019). The president of Takeda responded to the FDA announcement in January 2019 by saying “We have studied the safety of Uloric for more than 15 years and remain confident in Uloric as an important option for the chronic management of hyperuricemia in gout. We look forward to additional discussions with the FDA regarding these CARES data.”

Since the risk of CV events is increased in patients with gout, it is troubling to know that Takeda presented report after report of the findings of their drug Uloric, stating that there was a risk of adverse effects that include CV events. Despite this information and additionally required clinical trials, they aggressively marketed this drug to providers and to consumers that were already at risk. This led to hundreds of thousands of patients being prescribed the drug, who were unaware of the potential dangers associated with it.

Sources:

https://clinicaltrials.gov/ct2/show/NCT00102440

https://onlinelibrary.wiley.com/doi/full/10.1002/art.24209

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021856s000_Approv.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021856s011lbl.pdf

https://worldhistoryproject.org/2009/2/13/fda-approves-takeda-pharms-uloric

https://www.medicinenet.com/script/main/art.asp?articlekey=94500

https://www.medscape.com/viewarticle/898600

https://www.webmd.com/arthritis/news/20090216/fda-oks-new-gout-drug-uloric

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021856s000TOC.cfm

https://clinicaltrials.gov/ct2/show/results/NCT00174915?view=results

https://www.fda.gov/downloads/drugs/drugsafety/ucm584803.pdf

https://www.healio.com/rheumatology/gout/news/online/%7b5eff7ca8-878e-48de-aad2-6770ee0ef1d9%7d/fda-to-examine-heart-related-deaths-associated-with-febuxostat

https://www.acc.org/latest-in-cardiology/articles/2018/03/07/15/53/mon-8am-cares-cv-safety-of-febuxostat-and-allopurinol-in-patients-with-gout-and-cv-comorbidities-acc-2018

https://www.reuters.com/article/us-health-heart-gout-drug/newer-gout-drug-poses-risk-to-heart-patients-idUSKCN1GO26V

 

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Tracy R Everhart, MSN, MS CAM

For more than 20 years I've had the opportunity to work in numerous rolls within the medical field, including the last 7 years as a professional medical writer. With an undergraduate degree in biology/microbiology, postgraduate education in allopathic and complementary alternative medicine, my education has afforded me career opportunities with direct patient care, medical research and clinical oversight of statewide projects to improve the health of patients of all ages. I have a broad and deep knowledge of illnesses and conditions that can affect the human body. Even more important is that I have learned traditional treatment methodologies combined with alternative forms, to make the most informed decision about options that may be available.

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Opioid

Opioid Crisis

by with No Comment Drugs

An epidemic of addiction and death across the United States.

The use of opioid drugs has reached epidemic levels and has spread to every race, gender, socioeconomic class and nearly every age group of people in the United States. The Centers for Disease Control and Prevention (CDC) reports that these addictive drugs claim about 130 American lives on a daily basis and the numbers continue to increase annually. The question is, how did we as a nation get to this point and why?

What are opioids?

According to the National Institute of Health’s National Institute on Drug Abuse, “Opioids are a class of drugs that include the illegal drug heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription, such as oxycodone (OxyContin), hydrocodone (Vicodin), codeine, morphine, and many others”.

Opium

Opium became available in the US in 1775, but we believe that it has used by man since 3400 B.C. when it was first recorded in writing. The drug comes from the opium poppy (Papaver somniferum) seed pod sap, that contains various amounts of alkaloids such as morphine, codeine, thebaine, and papaverine. In the U.S. in the 1800s, opium dens started to spring up in the west (San Francisco’s Chinatown) and quickly spread east to New York. This was because of immigration and trading with other countries that cultivated the poppies and then supplied the drug. Opioids (morphine) were used to treat soldiers in the 1860s during the civil war and many soldiers became addicted to them. The US Congress banned opium in 1905 and in the following year they passed the Pure Food and Drug Act. This act required labeling of the contents on all medications.

Heroin

The Bayer Company was the first to produce heroin and in 1898, there were producing and distributing this new “miracle drug” on a commercial scale. It was found that it controlled pain levels better than codeine and morphine. However, it was also discovered that patients were developing a tolerance to the drug and quickly becoming addicted. It was eventually banned but it’s use gradually increased until the 1970s. Since that time we have seen a ten-fold increase in heroin use in the U.S.

Prescription Opioids

The Harrison Narcotics Act in 1914 regulated opioids (and coca leaves) to limit their recreational usage and by the 1970s, the stigma of addiction led doctors to avoid prescribing opioids. They opted for surgical procedures to block pain signals instead. However, in the 1980s and 1990s, opioids began to be used again to treat pain from chronic diseases. This when we saw a spike in new pain medications being approved and prescribed.

Here, we can look at the timeline of opioids that have been approved by the US Food and Drug Administration (FDA) over the years:

1947    Methadone (methadone hydrochloride) was approved as an antitussive and analgesic. In 1972 it was approved for opioid addiction treatment.

1957    Darvon (propoxyphene hydrochloride) was approved.*

1972    Darvocet (propoxyphene napsylate, acetaminophen) was approved.*

1983    Vicodin (hydrocodone bitartrate, acetaminophen) was approved.

1987    MS Contin (morphine sulfate) was approved. First opioid that allowed dosing every 12 hours instead of every 4-6 hours.

1989    Percodan (oxycodone HCI, aspirin) was approved.

1990    Duragesic (fentanyl transdermal system) was approved. First opioid “patch” that was designed to be worn for 3 days.

1995    OxyContin (oxycodone controlled-release) was approved. The first formulation of oxycodone that allowed dosing every 12 hours instead of every 4 to 6 hours.

1998    Actiq (fentanyl citrate) was approved. First pain medicine approved to treat cancer breakthrough pain.

1999    Percocet (oxycodone and acetaminophen) was approved.

*Darvon and Darvocet were banned in 2010.

Most of these have become common household names, but they didn’t start that way. Many were originally designed and prescribed for severe acute pain. Prescriptions were written in very limited quantities or were mainly used in hospital settings. But by the period of 2012-2016, the sales data that was analyzed by the FDA shows that products that were sold from manufacturers to pharmacies and other settings, revealed that sales to retail settings accounted for the majority of the annual opioid analgesic sales (>80%) and injectable formulations accounted for less than 0.2% of those sales. This means that there has been an enormous shift in the sales of these drugs from in-patient settings (hospitals) to outpatient settings (pharmacies), to then be dispensed to the general public. This peaked in 2011 with doctors writing 238 million opioid analgesic prescriptions annually.

Opioid Addiction

There are some staggering statistics when we look at the number of individuals that are diagnosed with opioid use disorder (addiction) in the United States. The National Institute on Drug Abuse provides us with annual figures that include the effects that this has on public health and social and economic welfare. They estimate that nearly 1.7 million people in the United States suffer from substance use disorders related to prescription opioid pain relievers and 21 to 29 percent of all patients that are prescribed opioids for chronic pain will misuse them. Unfortunately, opioid deaths are the reality of opioid drug misuse. The CDC also has stated that around 68% of the more than 70,200 US drug overdose deaths in 2017 involved an opioid.

Opioid Deaths

We know that in the 1990s there was growing pressure in the health care industry to treat pain more aggressively and as a result, pharmaceutical companies focused on the development of new pain medications. These companies also marketed the drug aggressively to doctors. They were marketed as safe medications that provided long-term relief. These doctors were told that less than 1% of all patients that were prescribed medications abused them and they should be prescribing more to help their patient in pain. Many critics believe that there was a concerted effort by the pharmaceutical companies to mislead the public and physicians about the dangers.

Since then, millions of Americans have abused prescription opioids. The federal government reports that more than 130 people now die each day from opioid overdoses, though not all of those drugs were obtained by prescription. A study published in the Harvard Review of Psychiatry found that the death rate from opioid misuse is 6 to 20 time greater than that the general population.

The CDC estimates that the total “economic burden” of just prescription opioid misuse in the United States is $78.5 billion a year. This includes the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement. Because of this economic burden, local and state governments believe that the pharmaceutical companies should pay for the cost associated with this epidemic. Public officials hope for an outcome similar to the massive tobacco settlement of the 1990s.

Opioid Lawsuits

In an effort to reduce risk and maximize the benefits of available pain treatment options, the CDC issued comprehensive guidelines for prescribing opioids for chronic pain outside of cancer treatment, palliative care, and end-of-life care. These prescribing recommendations stated that non-opioid treatments are preferred as the first step for treatment of chronic pain. As a result of the attempts by the CDC to change opioid prescribing patterns, they have been opposed primarily by indirect intervention. This has been done by the pharmaceutical industry through lobbying and advocacy groups.

A coalition of 41 states’ attorneys general has filed lawsuits against five major opioid manufacturers (Endo International, Janssen Pharmaceuticals, Teva Pharmaceutical Industries Ltd./Cephalon Inc. and Allergan). Subpoenas have been served and they are seeking information about how these companies marketed and sold prescription opioids. This group also served a supplemental investigative subpoena to Purdue Pharma.

The coalition is also demanding documents and information related to distribution practices from three drug distributors (AmerisourceBergen, Cardinal Health and McKesson). According to reports by the Drug Channels Institute, these three companies had more than $400 billion in revenue in 2016 and manage about 90% of the country’s national drug distribution.

Forbes recently published an article that stated that they believe that “opioid lawsuits on par to the become largest civil litigation agreement in U.S. history”. To date, there are numerous lawsuits that have been filed in relation to the opioid crisis. The largest case to date is one filed in the US District Court of Ohio, in which municipalities from across the country are seeking damages from this opioid crisis. The judge, in this case,  Dan A. Polster, has called the opioid epidemic a “man-made plague, twenty years in the making” and has refused a motion by drug companies to dismiss the case. He is urging both sides to come to an agreement in what could amount to billions of dollars. 

References:

https://history.house.gov/Historical-Highlights/1901-1950/Pure-Food-and-Drug-Act/

https://www.cdc.gov/drugoverdose/epidemic/index.html

https://www.ncbi.nlm.nih.gov/pubmed/11862675

https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74769ap_appltr_prntlbl_chemr.pdf

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020747

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018248

https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40-330_Oxycodone%20and%20Acetaminophen.pdf

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=010997

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/007337-S24_Percodan_toc.cfm

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=088058

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=017122

https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM598899.pdf

https://www.drugabuse.gov/drugs-abuse/opioids/opioid-overdose-crisis#two

https://journals.lww.com/hrpjournal/Abstract/2015/03000/Long_Term_Course_of_Opioid_Addiction.3.aspx

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3021365/

https://www.abcactionnews.com/news/local-news/i-team-investigates/opioid-lawsuits-1-000-local-governments-sue-drug-makers-pharmacies

Tracy-Headshot

Tracy R Everhart, MSN, MS CAM

For more than 20 years I've had the opportunity to work in numerous rolls within the medical field, including the last 7 years as a professional medical writer. With an undergraduate degree in biology/microbiology, postgraduate education in allopathic and complementary alternative medicine, my education has afforded me career opportunities with direct patient care, medical research and clinical oversight of statewide projects to improve the health of patients of all ages. I have a broad and deep knowledge of illnesses and conditions that can affect the human body. Even more important is that I have learned traditional treatment methodologies combined with alternative forms, to make the most informed decision about options that may be available.

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valsartan-recall

Valsartan Recall

by with No Comment Drugs

The reason this blood pressure medication has been recalled, and the complications associated with it.

Written by Tracy R Everhart, MSN, MS CAM

Valsartan®

This medication is prescribed to individuals that have been diagnosed with high blood pressure (hypertension) and congestive heart failure. Valsartan® is part of a class of medication that are called Angiotensin II receptor blocker (ARB) and is available in several different forms. These include:

  • Valsartan® tablets (40, 80, 160 and 320mg)
  • Valsartan® and hydrochlorothiazide (HCTZ) tablets (80mg/12.5 mg, 160mg/12.5 mg, 160mg/25 mg, 320mg/12.5 mg, and 320mg/25 mg)
  • Amlodipine and valsartan tablets (5mg/160mg, 5mg/320mg, 10mg/160mg and 10mg/320mg)
  • Amlodipine, valsartan and hydrochlorothiazide tablets (5mg/160mg/12.5 mg, 5mg/160mg/25mg, 10mg/160mg/12.5mg, 10mg/160mg/25mg, and 10mg/320mg/25mg

Why has this drug been recalled?

In July 2018, the U.S. Food and Drug Administration (FDA) announced a voluntary recall of several medications that contained the active ingredient valsartan. The companies listed in this original release included Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries, Inc.  The FDA made it very clear at the time, that not all valsartan-containing medication sold in the U.S. were part of the recalled.

These products contained valsartan that was supplied to these manufacturers by Zhejiang Huahai Pharmaceuticals (Linhai, China) and were found to contain an impurity known as N-nitrosodimethylamine (NDMA). Patients were advised to contact their physician or pharmacy if they had any questions about the brand of Valsartan® that they were taking.

Based on laboratory studies, NDMA is classified as a likely human carcinogen (a substance that could cause cancer) and the Environmental Protection Agency (EPA) classifies NDMA as a probable human carcinogen and that exposure to high levels of NDMA may cause liver damage.

By the end of 2018, another carcinogen was found in samples that were recalled (N-Nitrosodiethylamine (NDEA)) and the number of recalled medications containing Valsartan® had increased so significantly that the FDA set up a webpage containing a list of those drugs. This list includes the manufacturer’s name, the drug, the dose, the lot numbers, and the expiration dates.

Carcinogenic effects of N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA)

Numerous studies conducted in the early 1990s indicated the carcinogenic effects of NDMA. During this time nitrates and nitrites were routinely used as food additives in processed meats such as ham, bacon, sausages, and hot dogs. These were added to prevent spoilage and preserve the appearance and flavor of these meat products. High consumption of processed meats has been shown to be linked to an increase in gastric cancer risk, and many researchers consider nitrates/nitrites as the main cause.

Nitrosamines are produced by chemical reactions of nitrates, nitrites and other proteins and (NDMA) is one of the most frequently occurring nitrosamines found in foods. NDMA is known to be a potent carcinogen. It is capable of inducing malignant tumors in different laboratory animal species. The cancer induced in these laboratory animals was seen in a variety of tissues, including liver, lung, and stomach.

Nitrosodiethylamine (NDEA) is classified by the Environmental Protection Agency (EPA) as a probable human carcinogen and has primarily been used in research studies of laboratory rats when it is necessary to induce liver cancer.  The EPA fact sheet for NDEA states that chronic (long-term) exposure may cause liver damage and low platelet counts. They go on to say that animal studies suggest that chronic ingestion may cause liver tumors or other tumors, but the data of the carcinogenic effects of NDEA in humans are limited.

Impact on patients taking Valsartan®

  • Since the discovery of NDMA and NDEA impurities in valsartan, the FDA recommended that those patients who were taking one of the affected drugs continue taking the medication until their physician or pharmacist provided an alternative medication or replaced it with a different brand. They continue to make this recommendation based on the fact that the risk of stopping the medication outweighs the risk of continued use.

It is unknown how the exposer to the different levels of these two carcinogens will affect the patients that took the various versions of this drug. However, the first case was filed in New York against manufacturers of these drugs and the pharmacies that dispensed them. The case, Duffy vs Prinston Pharmaceutical, Inc., Solco Healthcare U.S., L.L.C., Throggs Neck Pharmacy and  Walgreen Co. (Walgreens) was filed on August 16, 2018, and on October 11, 2018, it was transferred to the United States District Court for the District of New Jersey.

This case (1:18-cv-07460-RJS) has been filed as a class action lawsuit, sighting that the manufacturers of the recalled drugs produced and distributed a generic version of valsartan that contained carcinogenic impurities and that these impurities went undetected for six years. The filing states that this case seeks equitable relief and to recover damages and restitution for: 

  • Breach of express warranty,
  • Breach of the implied warranty of merchantability,
  • Violation of New York’s General Business Law §§ 349, 350 (Consumer Protection From Deceptive Acts and Practices),
  • Unjust enrichment,
  • Fraudulent concealment,
  • Fraud,
  • Conversion,
  • Strict products liability
  • Gross negligence,
  • Negligence, and
  • Battery

The plaintiffs, in this case, were prescribed valsartan for an extended period of time and each time that they refilled their prescriptions, they received information about the medication, including “representations and warranties that the medication was properly manufactured and free from contaminants and defects”. They also received notification via U.S. Mail advising him that the valsartan-containing medication that they were taking was affected by the recall. It is unknown at this time how many manufacturers have produced contaminated valsartan as the list continues to grow. It is also unknown how many individuals will be affected by these carcinogenic impurities.

Sources:

https://www.epa.gov/sites/production/files/2014-03/documents/ffrrofactsheet_contaminant_ndma_january2014_final.pdf

https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm

https://www.mdpi.com/2072-6643/7/12/5505/htm#B10-nutrients-07-05505

https://onlinelibrary.wiley.com/doi/abs/10.1002/(SICI)1097-0215(19960328)66:1%3C130::AID-IJC22%3E3.0.CO;2-G

https://www.sciencedirect.com/science/article/abs/pii/0165121891901234

https://www.tci-thaijo.org/index.php/vis/article/view/124770

https://www.epa.gov/sites/production/files/2016-09/documents/n-nitrosodimethylamine.pdf

https://dockets.justia.com/docket/new-york/nysdce/1:2018cv07460/499403

https://law.justia.com/codes/new-york/2013/gbs/article-22-a/

Tracy-Headshot

Tracy R Everhart, MSN, MS CAM

For more than 20 years I've had the opportunity to work in numerous rolls within the medical field, including the last 7 years as a professional medical writer. With an undergraduate degree in biology/microbiology, postgraduate education in allopathic and complementary alternative medicine, my education has afforded me career opportunities with direct patient care, medical research and clinical oversight of statewide projects to improve the health of patients of all ages. I have a broad and deep knowledge of illnesses and conditions that can affect the human body. Even more important is that I have learned traditional treatment methodologies combined with alternative forms, to make the most informed decision about options that may be available.

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Onglyza Heart Failure Complications

Onglyza Heart Failure Complications

by with No Comment Drugs

Written by April Klazema

Onglyza Heart Failure Complications

On July 21, 2009, the Food and Drug Administration approved saxagliptin, a drug marketed under the trade names Onglyza and Kombiglyze XR by its developers Bristol-Myers Squibb and AstraZeneca. Targeted at assisting type 2 diabetics to manage their ailment, Onglyza has since been shown to increase by at least 27% the possibility that patients will require hospitalization for complications related to heart failure. By 2017, both companies faced more than a dozen lawsuits from plaintiffs who alleged AstraZeneca ignored — or did not investigate — the drug’s effect on cardiovascular health.

 

A year later in February of 2018, docket reporting indicated the number of active suits concerning Onglyza had grown to 84. By July of the same year, that number had exceeded 200 as more individuals confront saxagliptin’s risks and ramifications. If you or a loved one is or has been taking Onglyza, understanding all the facts and what your options may be is very important.

What is Onglyza, AKA Saxagliptin?

Type 2 diabetes is a common concern, with almost 1.5 million new cases diagnosed in the United States every year. Characterized by increased physical resistance to insulin and its ability to regulate blood sugar, this disease increases the risk of nerve damage, damage to the kidneys, and even the potential to lose extremities due to complications. A wide variety of pharmaceutical products exist to help address various aspects of this disease. Onglyza is one, intended for use with changes in the patient’s diet and exercise habits. In some cases, it is administered as part of a combination drug therapy.

 

The active compound in the drug, saxagliptin, works by stimulating the body’s natural ability to create insulin through specialized cells called incretins. In other words, Onglyza attempts to treat type 2 diabetes by causing the body to produce enough insulin to overcome the body’s resistance. In combination with lifestyle changes, the aim is to preclude the possibility of kidney damage. However, other types of drugs in this class, called “incretin mimetics” for their ability to act like natural incretics, have faced recalls in Europe and widespread concerns over side effects more severe than anticipated. These are the same concerns now levelled at Onglyza through ongoing litigation.

onglyza

Typical and Expected Side Effects

Like all drugs, however, some side effects are considered “normal” or “expected,” and received sufficient study and documentation during the trial process for the FDA to grant its approval. Typically, individuals who take Onglyza can expect to experience some side effect symptoms, such as:

 

  • Headaches
  • Upper respiratory or urinary tract infections
  • Nasopharyngitis
  • Bloating

 

A growing number of patients who have relied on Onglyza now allege that the risk of other, more serious side effects was negligently concealed or downplayed during the initial FDA review process. While some patients report the development of pancreatic and thyroid cancers as a result of taking Onglyza, by far the most widespread concern involves an elevated risk of heart and/or kidney failure, especially for those already suffering from diseases of these organs. Typical signs of heart failure can include:

  • Shortness of breath, especially during routine activity
  • Unusual fatigue or persistent exhaustion
  • Sudden weight gain accompanied by swelling, especially in the legs or stomach area

Do not abruptly discontinue medication without advice and consent from your doctor; seek medical assistance without delay if you take Onglyza and experience any of these symptoms.

Heart Failure Concerns Prompt Litigation

Given the FDA’s own 2008 guidance that drugs should not unacceptably raise cardiovascular risks, more patients and doctors expressed concern. A 2013 paper published in the New England Journal of Medicine examined more than 16,000 patients and concluded that while Onglyza itself was not directly responsible for adverse cardiac events, it did significantly increase how frequently patients went to the hospital for heart failure-related problems. The researchers concluded that the increased risk required further study and more vigilance from doctors in managing said risk.

By 2014, the FDA announced that it would take another look at Onglyza with a thorough review of the full clinical trial data. The result of this review was the determination of a small increase in the risk of hospitalization versus patients who received a placebo. In the FDA’s view, this increased risk did not outweigh the potential advantages of administering Onglyza, and thus the drug retained its approval and remains available for sale.

New Black Box Labels and Ongoing Events

While the FDA did not act against Onglyza’s developers and issued no recall, they did recommend the inclusion of a stronger warning concerning the risks. In 2016, the agency took more direct action, mandating a new black box warning label concerning the increased risk of heart failure for not only Onglyza and Kombiglyze XR but also several other drugs for the treatment of diabetes. By the following year, though, the first lawsuits against Bristol Myers-Squibb and AstraZeneca began.

A suit filed in the Southern District of Texas alleges that during drug development, the manufacturers ignored FDA guidance about minimizing cardiovascular risks carried by new drugs. In fact, the filing contends that in their rush to market the manufacturers did not carry out the necessary heart-related studies whatsoever.

The plaintiff in the case says that as a result of these actions and the drug’s availability on the market, he suffered severe and permanent deleterious health effects. AstraZeneca maintains that the company carried out all its required due diligence. Nonetheless, dozens and then hundreds more lawsuits quickly flooded into the courts as more patients from the 2010-2015 period before the new warnings sounded the alarm about their conditions.

Should You Seek an Attorney for an
Onglyza-related Claim?

Individuals who took Onglyza before the inclusion of the new warnings may be eligible to file or join a lawsuit related to the drug makers’ alleged malfeasance. However, drug liability litigation is many-layered and complex, and navigating these murky waters requires a clear understanding of the law, your case, and the state of other ongoing lawsuits. For these reasons, if you believe you may have a valid claim related to undisclosed saxagliptin side effects from heart failure to certain types of cancer, it is essential you connect with an experienced legal professional.

Sources

https://www.webmd.com/drugs/2/drug-152753/onglyza-oral/details

https://www.fda.gov/Drugs/DrugSafety/ucm486096.htm

https://www.fiercepharma.com/pharma/az-bms-slapped-14-lawsuits-over-onglyza-heart-failure-risks

https://www.drugs.com/history/onglyza.html

https://www.drugs.com/nda/onglyza_090402.html

https://topclassactions.com/lawsuit-settlements/lawsuit-news/56768-onglyza-study-shows-potential-heart-failure-side-effects/

http://www.diabetesincontrol.com/fda-extends-review-timeline-for-onglyzasaxagliptin-by-90-days/

https://www.spglawfirm.com/defective-drugs/onglyza-lawsuit/

https://www.everydayhealth.com/drugs/onglyza

https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/1042/onglyza-saxagliptin

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Invokana

Invokana Amputation Risks

by with No Comment Drugs

INVOKANA® is a pharmaceutical for diabetics that blocks sugar from being absorbed into the bloodstream, and it is associated with devastating side effects. More than 1,000 lawsuits have been filed against drug makers Janssen Pharmaceuticals and Johnson & Johnson, which Janssen is a division of. INVOKANA® is a class of type 2 diabetes drug known as an SGLT2 inhibitor. The severe side effects it is associated with include an increased risk of lower-limb amputation, ketoacidosis, kidney injury, and Fournier’s gangrene, a destructive genital disease. Plaintiffs who have filed lawsuits claim that Janssen and Johnson & Johnson failed to provide adequate warning to patients about the severe side effects and potential hazards of taking INVOKANA®.

Proceedings were begun by Janssen in October 2018 for the establishment of a settlement fund for a majority of the 1,100 lawsuits that had been filed against the company.

Why Lawsuits are Being Filed Against INVOKANA®

The safety of taking canagliflozin, the active ingredient in INVOKANA®, has been called into question, as many taking the SGLT2 inhibitor have suffered increasing illnesses and some have died from related complications. The U.S. Food and Drug Administration (FDA) approved INVOKANA® in March 2013 amidst praise that it was a new class of SGLT2 inhibitors that would significantly help individuals with type 2 diabetes.

Thousands who have made legal claims reference the results of studies which were cited by the FDA, those being CANVAS and CANVAS-R studies. Based on the results, the drug makers failed to adequately warn consumers about known risks of taking INVOKANA®. Rather than warn diabetes patients, the medication was promoted for off-label purposes, such as reducing blood pressure, treating weight loss, and improving cardiovascular (CV) function.

Claimants say that they were denied the opportunity to make an informed decision about whether to take canagliflozin, since the proper warnings were not provided.

Severe Side Effects of taking INVOKANA®

INVOKANA® Causes Lower-Limb Amputations

Severe foot problems are symptoms of diabetes, a condition that causes poor circulation, peripheral arterial disease, and nerve damage. Partial or complete amputation of the feet is associated with diabetes. The FDA conducted a study which found that, over the course of one year, leg and foot amputations were required twice as often among people who took INVOKANA®, compared to diabetics who took a placebo, which is an inactive treatment. The most common of the amputations associated with taking INVOKANA® were the toe and middle of the foot. Sometimes, however, the amputations involved the leg, below the knee. Some patients had more than one amputation and some involved both limbs.

The FDA also found that the most common precipitating medical events leading to amputations were gangrene, lower limb infections, ischemia, and diabetic foot ulcers. Those who were most at risk for amputation were those with a baseline history of neuropathy, peripheral vascular disease, and a prior amputation.

An initial safety alert was released by the FDA in May 2016 in which the public was informed that taking INVOKANA® or Invokamet can increase the risk of needing a foot or leg amputation. Invokamet is a prescription medication that combines INVOKANA® and metformin in one pill. Metformin is in a different class of drugs used to treat diabetes and prediabetes.

Specific information about the two-fold increased risk of lower limb amputations being associated with taking INVOKANA®, as compared with diabetes patients who did not take the medication, was not required by the FDA as a black box warning to be added to the INVOKANA® label until 2017.  

The alleged failure of Janssen to inform patients of the increased risk of amputation is the subject of many lawsuits against the company. The complainants seek compensation for pain and suffering caused by amputations, treatment costs, and other applicable expenses.

INVOKANA®, an SGLT2 Inhibitor, Causes Fournier’s Gangrene

Diabetics have an increased risk for developing a rare condition called Fournier’s gangrene, which is a life-threatening bacterial infection. The risk is increased when taking SGLT2 inhibitors. For males and females, the infection occurs in and around the genitals and can cause severe damage and death. The bacterial infection develops underneath the skin surrounding nerves, blood vessels, muscles, and fat of the perineum, which is the area between the anus and the genitals. The way the bacteria enters the body is typically through a break or cut in the skin. The condition spreads quickly and destroys the affected tissue.

In the five years ending May 2018, the FDA identified a dozen cases of Fournier’s gangrene in patients taking an SGLT2 inhibitor. There may have been more instances of diabetics suffering from the condition because the 12 cases were reports found in medical literature and submitted to the FDA. Among the 12 were five women and seven men. Within a few months of the patients taking an SGLT2 inhibitor, Fournier’s gangrene developed. In most instances, the patients stopped taking the medication. All of the 12 were hospitalized, some required surgery, and some required surgeries that were disfiguring. Some of the patients had multiple disfiguring surgeries. Among some of those, complications occurred, and one of the patients died.

By comparison, a previous 30-year review of antidiabetic drug classes identified only six cases of Fournier’s gangrene, all of which were in males.

Any patient with diabetes, whether taking an SGLT2 inhibitor like INVOKANA® or not, should immediately seek medical treatment if experiencing any of the following symptoms in the area of the genitals, particularly when combined with a fever above 100.4◦ F or generally feeling unwell:

  • Redness
  • Tenderness
  • Swelling of the perineum (area between the genitals and rectum)

INVOKANA® can Trigger Diabetic Ketoacidosis

Diabetic ketoacidosis is a potentially deadly condition and another serious medical risk associated with taking INVOKANA®. When ketone levels in the body rise too high, diabetic ketoacidosis occurs. Ketones are produced when glucose can’t be used by the body’s cells as a source of energy, and the body begins to break down fat. Acid levels in the blood also rise too high. When these conditions are present, it doesn’t take long for life-threatening diabetic ketoacidosis to occur.

The following are symptoms of diabetic ketoacidosis:

  • Increased need to urinate
  • A feeling of burning when urinating
  • Intense thirst
  • Fatigue
  • Nausea
  • Abdominal pain
  • Shortness of breath
  • Fruit-smelling breath odor

Advanced symptoms of diabetic ketoacidosis include:

  • Vomiting
  • Difficulty breathing
  • Confusion
  • Fainting or dizziness
  • Unconsciousness

In May 2015, the FDA issued a warning about the risk of developing ketoacidosis when taking SGLT2 inhibitors. In a review of the FDA Adverse Event Reporting System (FAERS) database during a five-year period ending May 2015 involving patients with type 1 or type 2 diabetes treated with SGLT2 inhibitors, the FDA identified 73 cases of ketoacidosis. There may have been additional cases that were not reported to the FDA. Among the 73 patients, all of them required emergency department treatment or hospitalization. Treatment of ketoacidosis was delayed in some of the cases because the blood glucose levels were below expectations for a patient suffering from diabetic ketoacidosis.

The FDA issues another warning on December 4, 2015, saying, among other things, that ketoacidosis is a serious condition and patients taking an SGLT2 inhibitor should immediately stop taking the medication and seek medical attention, if suffering from symptoms of ketoacidosis.

Taking INVOKANA® can Lead to Kidney Failure

In an FDA Safety Announcement dated June 14, 2016, an existing warning about the risk of acute kidney injury (renal failure) when taking certain type 2 diabetes medications, including INVOKANA®, was strengthened. Warnings on drug labels were revised to include information about the risk and recommendations for minimizing the danger. Acute kidney injury is a serious condition in which dangerous levels of wastes build up in the body because the kidneys suddenly stop working.

The FDA advised patients to immediately seek medical treatment if they experience signs and symptoms associated with acute kidney injury, such as the following:

  • Decreased urine
  • Swelling of feet or legs

From March 2013, the time canagliflozin was approved, through October 2015, reports were submitted to the FDA regarding 101 confirmable cases of kidney failure. Some of the patients required hospitalization and dialysis. About half of the patients said renal failure occurred within 1 month of taking canagliflozin (INVOKANA®) or dapagliflozin. Most said they improved after they stopped taking the medication. Some of the patients were younger than 65 years of age. Some had low blood pressure, were dehydrated, or were taking other medications that have an effect on the kidneys. Patients who already have a kidney disease were warned by the FDA in a 2016 report that they have an increased risk of death when taking INVOKANA®.

Taking INVOKANA® can Lead to Acute Pancreatitis

Acute pancreatitis is a serious and sometimes fatal inflammation of the pancreas, and the condition has been identified as one of the potential side effects of taking INVOKANA®. Gallstones or alcoholism have typically been the causes of acute pancreatitis. Two studies conducted in 2016 found that patients had developed acute pancreatitis after taking INVOKANA® for a short period of time. In one case, the patient had only taken the diabetes medication for four days.

Statistics show pancreatitis is fatal for 1 in 10 patients who develop the condition.

INVOKANA® is Linked to Heart Disease

It was suggested in early studies that one of the side effects experienced by taking INVOKANA® is heart disease. Among the 15-members on the FDA approval panel, 8 of them expressed concern over clinical data linking the medication to an increased risk of having a heart attack.

Federal and State Invokana Lawsuits

The majority of federal lawsuits against INVOKANA® have been placed in the U.S. Court for the District of New Jersey for multidistrict litigation (MDL) under MDL 2750. 

Depending on factors such as a state’s laws, plaintiffs sometimes have a better chance at receiving compensation in an INVOKANA® lawsuit from state courts. Pennsylvania is the state with the most INVOKANA® lawsuits. The statutes of limitations are important considerations, in state court litigation. Individuals must file lawsuits within a state’s deadlines or risk losing the legal right to seek compensation.

INVOKANA® Verdicts and Settlements

There are currently no known verdicts on lawsuits filed in connection with INVOKANA®. Details of the October 2018 settlement fund for lawsuits filed against Janssen Pharmaceuticals are confidential, and full details were still in negotiation as of November 2018.

Compensations Available in INVOKANA® Lawsuits

INVOKANA® lawsuits are drug-related product liability cases. Legal compensation a person may be entitled to depends on the individual’s unique experience. Judges and juries consider things such as:

  • How long did the individual suffer from side effects of taking the medication?
  • What are the total costs to the patient and his or her family for treatment of side effects?
  • As a result of taking the drug, has the individual suffered any type of disability, whether temporary or permanent?

Some of the damages sought in INVOKANA® cases include:

  • Medical Costs
  • Loss of Income
  • Loss of Companionship
  • Pain and Suffering
  • Funeral Expenses

Contact the Johnston Law Group

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The Johnston Law Group offers experienced nationwide representation and specializes in representing people who have been seriously harmed by the actions of others, including injuries caused by dangerous drugs and medical devices.

Attorneys with the Johnston Law Group have been involved in some of the nation’s most high-profile personal injury cases. If you or a loved one have been harmed by taking INVOKANA®, contact us at the Johnston Law Group. Call toll-free today at (844) 464-0062.

Resources:

https://www.fda.gov/Drugs/DrugSafety/ucm557507.htm

https://www.healio.com/endocrinology/diabetes/news/online/%7B2bc50980-9d8e-4787-962a-3a9fff676e21%7D/fda-approves-cv-events-indication-for-invokana

https://www.fda.gov/Drugs/DrugSafety/ucm617360.htm

https://www.fda.gov/Drugs/DrugSafety/ucm475463.htm

https://www.fda.gov/Drugs/DrugSafety/ucm505860.htm

https://drugsafetynews.com/2016/12/13/invokana-sglt2-inhibitors-linked-acute-pancreatitis/

Written by:

stephaniemchugh-writer

Stephanie McHugh​

Stephanie McHugh is a professional writer who specializes in legal articles, technical blogs, and website copy. She is a former Official Court Reporter for a District Court in Houston, Harris County, Texas; newspaper columnist; and teacher. Stephanie is a professional writer with extensive experience reporting on health-related topics for publication. She developed an interest in health-related litigation as a court reporter while taking depositions for a class action lawsuit. Through her writing, she has been glad to help raise awareness about public health threats, to benefit victims.

Invokana

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Pradaxa Bleeding Complications

by with No Comment Drugs

Pradaxa® is a blood thinner associated with uncontrollable bleeding, death, and thousands of lawsuits. The manufacturer of the drug is Boehringer Ingelheim Pharmaceuticals. The Federal Drug Administration (FDA) initially approved Pradaxa® (dabigatran) in 2010. There were 540 deaths attributed to the anticoagulant in 2011. In addition, thousands of other patients suffered from serious side effects that same year. By 2014, 4,000 lawsuits against Boehringer Ingelheim were settled when the drug manufacturer paid out $650 million. Thousands more lawsuits against the drug maker are pending.

Red flags

It wasn’t long after Pradaxa® was released that trauma surgeons and emergency room physicians began reporting that patients taking Pradaxa® were suffering from life-threatening bleeding, and reversing the effects of the drugs was difficult. In the year following release of Pradaxa, 2011, the drug was cited on more reports of death or injury than any other drug being monitored that year by the Institute for Safe Medication Practices, according to a New York Times report.

Claims Made in Pradaxa® Lawsuits

Lawsuits against Pradaxa® are being filed because of uncontrollable bleeding and death as well as serious side effects. Pradaxa® increases the risk of brain bleeding, gastrointestinal bleeding, and heart attack, which can all cause death. The following are more of the common side effects of taking Pradaxa®:

  • Pink or brown urine
  • Bloody stools or black, tar-like stools
  • Stomach pain
  • Headache
  • Heartburn
  • Upset stomach and nausea
  • Vomiting or coughing up blood or a substance resembling coffee grounds
  • Difficulty swallowing or breathing
  • Excessive bleeding from a cut
  • Chest tightness or pain
  • Feeling faint, dizzy, or weak
  • Swelling or joint pain
  • Heavy menstrual bleeding
  • Frequent nosebleeds
  • Unusual bleeding or bruising

In addition, some patients have experienced allergic reactions to taking Pradaxa®. The following are signs of an allergic reaction, and patients who experience any of the symptoms should contact their doctor:

  • Feeling faint or dizzy
  • Swelling of your tongue or face
  • Difficulty breathing
  • Rashes, itching, and hives
  • Chest tightness or pain

Bleeding and Pradaxa®

It’s not always apparent when a person is experiencing internal bleeding. If you are taking Pradaxa®, it is important to be aware of signs that internal bleeding may be taking place. Severe symptoms of internal bleeding include vomiting or coughing up blood or a substance similar to blood, black or bloody stools, bleeding that takes longer than usual to stop, and bruising.

Clinical Trials

The first Pradaxa® clinical trials ran in 2009, and they were called RE-COVER I and Randomized Evaluation of Long-term Anticoagulant Therapy (RE-LY. Boehringer Ingelheim sponsored RE-LY. In the trials, the safety of Pradaxa® was compared to warfarin in the treatment of patients treated for pulmonary embolism (PE) and deep vein thrombosis (DVT). For decades, warfarin had been the traditionally used coagulant for preventing blood clots. In addition, the trials sought to determine whether Pradaxa® was more effective than warfarin at reducing the risk of stroke among patients with atrial fibrillation not caused by a heart valve problem.

The trials reportedly showed that Pradaxa® prevents blood clots leading to stroke as effectively as warfarin. In addition, Pradaxa® was easier to use and potentially caused fewer side effects. Warfarin requires frequent blood tests and is affected by food, and Boehringer Ingelheim has claimed that neither of those issues apply with Pradaxa®.

Clinical trials matching Pradaxa® head-to-head with warfarin became the catalyst for FDA approval, but studies done since that time have shown conflicting results. At the University of Pittsburgh, for example, 9,400 men and women with atrial fibrillation covered by Medicare were surveyed. The results of that study showed that 6% of those taking warfarin suffered a major bleed, compared to 9% of those who took Pradaxa®.

RE-SPECT ESUS is a current and ongoing clinical trial seeking to determine whether Pradaxa® can prevent a second episode of embolic stroke. The participants recruited have experienced a recent episode of embolic stroke of unknown source (ESUS). August 14, 2018, was the scheduled completion date. Results have not yet been released.

FDA Warnings

Pradaxa® has not been recalled by the government, in spite of the dangerous side effects and many deaths associated with the drug. However, the FDA has issued a black box warning regarding dangers associated with stopping the use of Pradaxa®. Patients who quit taking the drug can have an elevated risk of stroke and of experiencing a blood clotting complication. The FDA urges patients who wish to discontinue the use of Pradaxa® to only do so under the care and supervision of a doctor.

Patients sometimes need to stop taking Pradaxa® prior to a dental or medical procedure or surgery. Patients should speak to the physician who prescribed the blood thinner to them and find out when Pradaxa® should no longer be taken, leading up to the procedure. In addition, a doctor should give instructions on when to resume taking Pradaxa® again.

In addition, in patients who have an epidural or spinal tap, Pradaxa® can cause a dangerous blood clot in the spinal cord, which can lead to paralysis.

Pradaxa

Spinal Blood Clots and Pradaxa®

Patients have a heightened risk of developing a spinal blood clot after receiving a spinal tap or epidural if:

  • An epidural catheter is placed in your spine for the purpose of administering certain medications
  • You have a history of spinal surgeries and other spinal issues
  • You have a history of difficult or repeated spinal punctures
  • You are currently taking blood thinning medicines or other non-steroidal, anti-inflammatory drugs (NSAIDs).

You should be closely monitored by your doctor for signs of a spinal blood clot if you are taking Pradaxa® and receive a spinal puncture or spinal anesthetic. Immediately contact your doctor if you experience any of the following symptoms:

  • Numbness and tingling
  • Incontinence
  • Back pain
  • Muscle weakness, particularly in your feet and legs

Heart Attacks and Pradaxa®

Events such as heart attacks, acute kidney failure, stroke, and liver failure have been reported by patients using Pradaxa®, in addition to the most frequent adverse event, gastrointestinal bleeding. In two separate studies comparing Pradaxa® users with other patients using such blood thinning agents as warfarin, both published reports showed concurrently that there is an increased risk of heart attacks among patients taking Pradaxa®.

If you are taking Pradaxa® and experience any of the following severe symptoms of heart disease, immediately seek medical help:

  • Shortness of breath
  • Chest pain
  • Loss of consciousness and dizziness

Antidote and Reversal Agent for Pradaxa®

Pradaxa® was sold by Boehringer Ingelheim without a bleeding remedy for five years. During that five-year period, reports of adverse events among patients who took Pradaxa® quickly outpaced those who were treated with warfarin. Thousands of the patients taking Pradaxa® suffered uncontrollable bleeding, and sometimes it was fatal.

Accelerated approval of an antidote to uncontrollable bleeding suffered by Pradaxa® patients was approved by the FDA in October 2015. Praxbind (idarucizumab) can reverse the blood-thinning effects of Pradaxa® in patients experiencing uncontrollable bleeding. It is currently the only antidote for Pradaxa® that has been approved by the FDA.

Many healthcare providers are concerned about the safety of Praxbind, since it received accelerated FDA approval. Many medical professionals carefully advise patients to consider both benefits and drawbacks associated with taking Pradaxa® and other blood thinners that are relatively new.

Manufacturing, Design, and Marketing Defects

From the time of its release, Boehringer Ingelheim promoted Pradaxa® as a better option than the longer-used warfarin, with the following claims:

  • There are fewer interactions with other medications and with foods; and
  • Determining the correct dosage of Pradaxa® doesn’t require weeks of calibration, unlike warfarin.

These claims have seemingly been disproven, however. The following is a timeline of label updates and Pradaxa® warnings, providing a glimpse into proven results among patients taking the blood thinner:

2010: The drug label for Pradaxa® was updated after additional bleeding events in the RE-LY trial data were discovered.

2011: Reports of serious bleeding events resulted in a post-market review of the drug by the FDA. The organization sought to determine whether there were more than the expected number of incidents of serious bleeding.

2013: A black box warning was added by Boehringer Ingelheim regarding risks of discontinuing the use of Pradaxa® prematurely, and it states that some patients experience an increased risk of spinal hematomas.

2014: A safety communication was issued by the FDA, stating that Pradaxa® causes a greater risk of gastrointestinal bleeding than warfarin. In addition, the safety communication says Pradaxa® has a lower risk for ischemic stroke, death, and intracranial hemorrhage and a similar risk for myocardial infarction.

Many individuals involved in lawsuits against the drug maker argue that the higher risk of gastrointestinal bleeding is something they should have been aware of, and Boehringer Ingelheim should have appropriately warned doctors and consumers. Plaintiffs also claim that there was a violation in regulatory requirements because in the manufacture and marketing of Pradaxa®, there was not a proper warning regarding the serious, sometimes life-threatening, risks of taking the anticoagulant. By producing and promoting such a dangerous drug, plaintiffs also argue that Boehringer Ingelheim is guilty of a breach of warranty and of negligence.

Pradaxa® Bellwether Trials

Mary Boone was prescribed Pradaxa® by her doctor, to reduce her risk of a stroke from atrial fibrillation. Boone died on March 24, 2014, due to an uncontrollable gastrointestinal bleed. Her estate filed the first Pradaxa® case that went to a jury trial. According to court documents, Boehringer Ingelheim argued that the warnings for Pradaxa® were adequate, and the drug maker maintained that the deceased’s physician understood the risks involved in prescribing the drug. Members of the jury sided with the drug company in a verdict handed down on March 23, 2018.

A lawsuit filed by Mary Lou Gallam became the second Pradaxa® bellwether trial. According to court records, in 2011, Gallam was prescribed Pradaxa®; and she subsequently experienced a “major bleeding event” in April 2014. Gallam’s case was also a jury trial, and jurors found in favor of the drug company in a verdict given on May 7, 2018.

Have you Suffered Dangerous Effects of Pradaxa®?

You may be eligible to file a Pradaxa lawsuit if you took the blood-thinner and suffered dangerous effects, such as severe bleeding. In addition, if you are a family member of someone who died following complications associated with the drug, such as brain bleed or gastrointestinal bleeding, it is possible that you could recover lost income and expenses by filing a lawsuit.

Types of Pradaxa® Lawsuits

A short time after the release of the blood thinner in 2010, it was evident that patients were experiencing a higher than usual number of adverse events, such as dangerous gastrointestinal bleeding. Early on, Pradaxa® lawsuits were filed in various states and in different federal district courts. When a Pradaxa® lawyer has examined a case and determined that a viable claim exists, one of the following two basic types of Pradaxa lawsuits is filed:

  • Personal Injury Lawsuits involve claims made by patients who took the anticoagulant and suffered severe bleeding.
  • Wrongful Death Lawsuits are claims filed by family members who died as a result of bleeding complications associated with taking Pradaxa®.

Should I Get a Pradaxa® Attorney?

There are many complexities involved with lawsuits related to product liability. A notable complication is that drug makers make billions of dollars annually on their products, and they willingly spend millions of dollars in lawsuits, to maintain the status quo and protect their continued profits. For these reasons, it is very important to work with an experienced Pradaxa® lawyer.

stephaniemchugh-writer

Stephanie McHugh

Stephanie McHugh is a professional writer who specializes in legal articles, technical blogs, and website copy. She is a former Official Court Reporter for a District Court in Houston, Harris County, Texas; newspaper columnist; and teacher. Stephanie is a professional writer with extensive experience reporting on health-related topics for publication. She developed an interest in health-related litigation as a court reporter while taking depositions for a class action lawsuit. Through her writing, she has been glad to help raise awareness about public health threats, to benefit victims.​

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Sources

 

xarelto

Xarelto® Bleeding Complications

by with No Comment Drugs

Between federal and state courts, more than 20,000 Xarelto® lawsuits have been filed since the blockbuster drug was approved by the U.S. Food and Drug Administration (FDA) in 2011. Xarelto® is the nation’s most-prescribed blood thinner in its class. Drugmakers Johnson & Johnson and Bayer are the companies being sued on claims that knowledge about risks of significant bleeding were consciously concealed for the purpose of boosting sales. The more than 13 million prescriptions of Xarelto® filled since the drug’s release have generated billions of dollars for Johnson & Johnson and Bayer. Though the FDA has said that Xarelto® is associated with as many as 400 deaths, the government agency has not recalled the anticoagulant.

On December 5, 2017, a jury in a state court ordered the two mega-pharmaceuticals to pay plaintiff Lynn Hartman nearly $28 million due to complications such as internal bleeding that she experienced as a result of using Xarelto®. A doctor had prescribed Xarelto® for Hartman in treatment of atrial fibrillation and other health problems. The compensation the jury awarded to Hartman included $1.8 million in compensatory damages and $26 million in punitive damages.

Prior to the Hartman case, there were three bellwether trials in federal courts in which the defense in the Xarelto® lawsuits won. A bellwether trial involves a small consolidation of lawsuits taken from a larger group of cases to be tried first. Such trials often set precedent and help others anticipate how future trials may turn out. They can also help plaintiffs determine the types of legal arguments juries may be inclined to respond to.

What is Xarelto®?

Xarelto®, which is Rivaroxaban in the generic form, is an anticoagulant or blood thinner. An essential component of healing is coagulation, which is thickening or clotting of the blood. Coagulation prevents dangerously excessive blood loss when there is a cut or internal bleeding. Blood clots can also create significant risk, however, potentially causing catastrophic health problems. Blood thinners like Xarelto® are prescribed to help prevent these types of dangerous conditions.  Doctors prescribe Xarelto® for the following reasons and more:

  • To reduce the risk of blood clots and stroke in individuals with atrial fibrillation that was not caused by a heart valve problem.
  • To treat deep vein thrombosis (DVT), which occurs when a blood clot forms in one or more of the body’s deep veins. DVT most commonly develops in the legs.
  • To treat a pulmonary embolism (PE), which occurs when a blood clot gets caught in an artery that travels from the heart to the lungs. Pulmonary embolisms usually travel to a deep vein in the leg.
  • To reduce the reoccurrence of blood clots in patients who are experiencing a prolonged risk of developing DVT or PE, after blood clot treatments have continued for at least 6 months.
  • To reduce the risk of forming a blood clot in the lungs and legs, among people who have just had hip replacement or knee surgery.

Xarelto® Timeline of Events

The many thousands of Xarelto® lawsuits have come as a result of a range of problems with the blood thinner, and signs that the drug can be dangerous emerged quickly. After the 2011 release of Xarelto®, the following is a basic timeline of events related to reported dangers, reported income for Johnson & Johnson and Bayer, and more:

  • In 2012 alone, among the “serious adverse events” patients experienced after taking the prescription Xarelto®, 2,081 were reported to and filed with the FDA.
  • By 2013, the FDA added a black box warning on packaging for Xarelto®, related to spinal hematomas. The FDA, in other words, acknowledged the risk of the drug causing significant spinal cord compressions, potentially resulting in permanent and irreversible neurologic damage.
  • In January 2014, per the FDA, warnings had to be included on the insert of Xarelto® and Rivaroxaban packaging indicating that there is no antidote for Xarelto® bleeding.
  • In May 2014, there were settlements of 4,000 lawsuits amounting to $650 million total in cases related to the use of Pradaxa®, a blood thinner similar to Xarelto®.
  • By December 2014, there were more than 15,000 Xarelto® lawsuits with pending actions filed in multidistrict litigation (MDL). Judge Eldon Fallon in Eastern Louisiana established MDL.
  • In 2014 alone, Xarelto® generated $3.7 billion for Johnson & Johnson.
  • In 2016, Xarelto® generated $2.2 billion for Johnson & Johnson.
  • Three federal bellwether Xarelto® lawsuits resulted in defense verdicts in May, June, and August 2017. In December 2017, a jury awarded plaintiff Lynn Hartman $27.8 million.
  • In January 2018, a state court judge in Pennsylvania overturned the $27.8 million verdict.
  • In February 2018, the plaintiff filed an appeal of the reversal, hoping to obtain fair compensation for injuries suffered as a result of taking Xarelto®.

In May 2018, the FDA gave initial approval for the only antidote for uncontrolled bleeding caused by Xarelto. The antidote is called AndrexXa®, and it is expected to be available on the market by early 2019.

xarelto-timeline

Health Complications Caused by taking Xarelto®

People who have taken Xarelto® have experienced a wide range of complications, including death. More than 20,000 Xarelto® lawsuits claim that it is a dangerous drug. The complications and serious side effects patients have experienced from taking Xarelto® include cerebral hemorrhaging, stroke, epidural hemorrhaging, abnormal liver failure, gastrointestinal bleeding, rectal bleeding, stroke, painful urination, spinal hemorrhaging, and abdominal bleeding. Post-surgical complications associated with Xarelto® include infection, hematoma, and rupture. To correct wound complications related to the drug, revision surgery is sometimes necessary.

The common side effects of taking Xarelto® include low blood pressure, nausea and vomiting, muscle pain, edema or swelling, and nose bleed. Other side effects that have regularly been reported after taking the drug include a racing heartbeat, irregular heartbeat, dizziness, fainting, headaches, and pain or weakness in the extremities.

Warning Label & Other Updates

Although many thousands of problems have been reported in association with taking Xarelto®, it has not been recalled by the FDA. Individuals who have suffered serious health issues from taking the blood thinner and who are involved in Xarelto® lawsuits claim that Johnson & Johnson and Bayer have held back important information from the public. Since the drug’s release, there have been various warnings added to the packaging, alerting people of the most prominent risks of taking Xarelto®.

First Black Box Warning

A black-box warning added in August 2013 stated that there was a higher risk for deep vein thrombosis, blood clots, and epidural/spinal hematoma among patients who prematurely discontinued use of the blood thinner.

Warning: No Antidote

In January 2014, the FDA issued a warning or precaution that they were aware of a bleeding risk associated with taking Xarelto® or Rivaroxaban. Included in the warning was a recommendation that a patient receive blood replacement or transfusions if blood loss was experienced while taking the anticoagulant.

In addition, the warning discussed the lack of an antidote or reversal agent for Xarelto®. When a patient is taking most other types of blood thinners, doctors can counteract the anticoagulant properties in an emergency by administering protamine sulfate or vitamin K. Xarelto®, however, blocks Thrombin and, as a result, neither of the two antidotes work. This was explained on the page listing Xarelto® Side Effects. Also, the anticoagulant should not be used by anyone with prosthetic heart valves.

Epidural or Spinal Puncture Treatment Directive

In March 2014, patients taking Xarelto® received a directive in the second black box warning for the drug. The warning was specifically for patients undergoing a spinal puncture or epidural treatment. They were instructed to wait until Xarelto® has been flushed form their system before undergoing either of these procedures, due to a concern regarding spinal bleeds.

Thrombocytopenia and Hepatitis Warnings

An Adverse Reaction report on Xarelto® was issued by the FDA in December 2014. The warning was that the blood thinner could cause thrombocytopenia. Thrombocytopenia is a condition in which the body suffers from low blood platelet counts. Because blood platelets are crucial in the formation of blood clots, thrombocytopenia can cause internal bleeding.

On the same report, the FDA changed “cytolytic hepatitis” to “hepatitis” in the descriptions of adverse reactions and included hepatocellular injury, which is major injury to the liver.    

Dangerous Drug Interactions

The latest FDA warning added to Xarelto® packaging is in regard to dangerous drug interactions with the blood thinning medication. Among the drugs that should not be taken with Xarelto® are SSRI and SNRI antidepressants. The complete list of drugs that the warning said not to take with Xarelto® follows:

  • Carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Tegretol-XR, and Teril)
  • Conivaptan (Vaprisol)
  • Indinavir (Crixivan)
  • lopinavir (Kaletra)
  • Itraconazole (Onmel and Sporanox)
  • Phenytoin (Dilantin)
  • Rifampin (Rifadin, Rifamate, Rifater, and Rimactane)
  • Ritonavir (Norvir)
  • John’s wort (Hypericum Perforatum)

The FDA also added a warning that Xarelto® has not been tested in patients who have a prosthetic heart valve and such patients should not take the blood thinner.

Faulty Clinical Trial

Before drugs are approved by the FDA for general use, they must be clinically tested as a way of proving effectiveness and safety. There were some questions related to a clinical trial for Xarelto® because of the use of a device called the Alere INRatio, which was recalled in July 2016. The name of the clinical trial is ROCKET-AF, and it reportedly provided the primary information supporting the FDA’s approval of Xarelto® in 2011.

The recalled device was used for testing of blood clotting during clinical trials. Problems with the device used to establish approval of Xarelto® dated back to 2002. Before the 2016 recall of the Alere INRatio, studies concluded that the device had a propensity to provide false results favorable Xarelto®. The data collected from the faulty device showed that Xarelto® was likely the safer blood thinner for patients with atrial fibrillation, as compared with warfarin. More specifically, the ROCKET-AF study showed that the effects on bleeding, including bleeding in the head, and strokes were minimal among patients taking Xarelto®. That conclusion is in question.

Alternate Studies Not Favorable to Xarelto®

Over-the-counter aspirin has been compared to Xarelto® in various studies, and a common conclusion is that aspirin is as effective as Xarelto® in reducing the risk of systemic embolism and stroke. It has been acknowledged by Bayer as well as Johnson & Johnson’s Janssen Research and Development that Xarelto® failed a trial comparing the drug to aspirin in patients with recent embolic stroke of undetermined source or ESUS. In the study involving 7,214 patients from 31 countries, Xarelto® did not have greater efficacy than aspirin in reducing the risk of stroke and systemic embolism.

The most dangerous side effect of Xarelto® is the risk of unstoppable bleeding, which can be fatal. Since aspirin appears to be as effective, there seems to be no reason to take on the risks associated with Xarelto®.

In comparative studies of patients who had undergone hip or knee replacement surgery, some were given Xarelto® to reduce the risk of pulmonary embolism and deep vein thrombosis. Others received aspirin and compression socks. Patients in the latter group had fewer complications with their wounds than those who were treated with Xarelto®. The studies also showed that post-surgical complications included infection, rupture, hematoma, and the necessity for revision surgery, among those who used Xarelto®.

It has also been discovered through studies that when patients undergoing an epidural anesthetic or spinal tap take Xarelto®, they are at risk of developing a blood clot in the brain or around the spinal cord, leading to a variety of injuries, including stroke and paralysis.

Has Xarelto® Affected You or a Family Member?

If you or a member of your family have experienced issues such as excessive bleeding as a result of taking Xarelto®, contact The Johnston Law Group. Our mission is to hold drug companies accountable for consciously endangering patients by inadequately warning them of known potential health threats.

At The Johnston Law Group, we understand the financial challenges and heartbreak families face as a result of catastrophic prescription drug injury. Contact us today for a free consultation and for filing of a Xarelto® lawsuit.

Resources:
https://www.waterskraus.com/xarelto-vs-aspirinthe-outcome-may-shock/

https://www.bloomberg.com/news/articles/2018-08-26/bayer-j-j-s-blood-thinning-drug-xarelto-fails-mariner-trial

https://www.forbes.com/sites/legalnewsline/2018/06/12/unbeaten-at-trial-bayer-and-janssen-say-cycle-of-xarelto-lawsuits-needs-to-be-stopped/#2f6e10c6629f

https://www.reuters.com/article/us-bayer-xarelto/bayer-jjs-bid-to-further-widen-use-of-xarelto-hits-snag-idUSKCN1LC0QS

https://www.xarelto-us.com/about-xarelto/xarelto-vs-warfarin

https://www.xareltohcp.com/frequently-asked-questions

https://www.phrma.org/

Written by:

stephaniemchugh-writer

Stephanie McHugh​

Stephanie McHugh is a professional writer who specializes in legal articles, technical blogs, and website copy. She is a former Official Court Reporter for a District Court in Houston, Harris County, Texas; newspaper columnist; and teacher. Stephanie is a professional writer with extensive experience reporting on health-related topics for publication. She developed an interest in health-related litigation as a court reporter while taking depositions for a class action lawsuit. Through her writing, she has been glad to help raise awareness about public health threats, to benefit victims.

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