In December 2012, the Federal Drug Administration (FDA) approved a new anti-clotting drug, Eliquis (apixaban), to help prevent strokes and blood clots for patients with atrial fibrillation which is not caused by a heart valve problem. Eliquis is made by Bristol-Myers Squibb and marketed by Bristol-Myers Squibb and Pfizer.
Atrial fibrillation is an abnormal heart rhythm. The two upper chambers of the heart, the atria, do not contract as they should and, as a result dangerous blood clots can form. A blood clot that forms in the heart can move to the brain and cause a stroke. Eliquis is supposed to prevent these kinds of strokes and was found to be more effective in preventing strokes than warfarin in a pre-market study of more than 18,000 patients.
The FDA Approval Process Has Been Criticized
According to Bloomberg News:
“Bristol-Myers Squibb Co. and Pfizer Inc.’s blood thinner Eliquis, approved in December, was stalled for nine months because of misconduct, errors and an alleged cover-up attempt at a Chinese trial site overseen by Bristol-Myers, according to documents posted by the U.S. Food and Drug Administration. The delay came after the company told the FDA that patients got the wrong medicine, records were secretly changed and ‘serious adverse events’ went unreported, the documents show.”
Approximately 16 percent of the 18,000 people involved in the pre-market study were located in China. Questions about altered records and inadequate oversight of the study remain even after Bristol-Myers and Pfizer defended the study procedures and results.
FDA Warns of Problems After Eliquis Is On the Market
Since its approval of Eliquis in December 2012, the FDA has updated its safety label several times. Specifically, the FDA has warned about…
- Use of the drug among people with end-stage renal disease maintained with hemodialysis. This was added as a precaution in January 2014. Updated information specific to this population was provided by the FDA in June 2015.
- The dangers of premature discontinuation of Eliquis in August 2014. This warning was so significant that an FDA boxed warning was added to the medication to inform patients that ending use of the drug prematurely could result in a thrombotic event.
- Bleeding events. The adverse reactions section of the Eliquis safety label was updated in September 2015 with this information.
The FDA is not the only source of information we have that patients have been hurt.
Eliquis Lawsuits Have Been Filed
Eliquis lawsuits may be filed by survivors of those who died because of uncontrollable bleeding with taking Eliquis. The lawsuits may allege:
- Fraud: More specifically, that manufacturers purposely concealed side effects of the drug.
- Failure to warn about side effects: Manufacturers have a duty to warn patients and doctors about known side effects and side effects which should be known if adequate studies are completed.
- False advertising or false claims: Survivors may claim that the advertisements for Eliquis did not adequately convey the risks.
Additional claims, such as negligence, may also be brought.
Filing a lawsuit against a pharmaceutical giant such as Bristol-Myers Squibb or Pfizer is not easy. These companies have a lot of money at stake and they have a team of attorneys working to protect their interests.
If you have been hurt or if you have lost a loved one, then you also deserve to have a dedicated legal team on your side. Please contact our experienced attorneys today to learn more about protecting your rights and your future.