FDA Takes Heat for Fast-Tracking Pradaxa
By Mark Favaloro, Medical Malpractice Lawyer
In a recent article published in the Journal of the American Medical Association (JAMA), researchers reviewed the safety records of Pradaxa, as well as several other drugs that received approval under one of the FDA expedited approval programs designed to fast-track certain drugs to the market. According to the researchers, Pradaxa, multiple sclerosis drug Gilenya, and thyroid cancer drug Caprelsa, each “raise the question of whether it was good policy to approve three innovative new drugs with significant safety questions unanswered and with optimal doses not determined.”
The researchers specifically mentioned the bleeding risk associated with Pradaxa, as well as its lack of an antidote, and said that bleeding in patients taking the blood thinner may be harder to treat than bleeds related to the older blood thinner warfarin. The article concluded that Pradaxa raised enough concern that the drug should have been subject to stricter scrutiny than the speedy approval by the FDA.
The researchers claim that Pradaxa, which is used to reduce the risk of stroke and blood clots in patients with atrial fibrillation, went through priority review and was thus fast-tracked by the FDA. According to the FDA, the purpose of the fast-track process is to introduce important, new medications to patients more quickly.
Unlike warfarin, Pradaxa does not require weekly doctor check-ups and dietary restrictions and was seen as the first replacement of the difficult-to-use blood thinner. Since its introduction into the market, however, Pradaxa has been at the center of a storm regarding reports of serious bleeding. In 2011 alone, the drug was responsible for 3,781 adverse events reports, more than any other drug monitored by the FDA.
The Virginia Injury Lawyer’s Perspective:
Since the news of the negative affects of the drug came to light, Pradaxa has been in the spotlight as dozens of lawsuits have been filed against the drug’s manufacturer, Boehringer Ingelheim. Sickened Virginia patients have alleged that the drug led to serious and even fatal bleeding, a problem that they say they were never properly warned about.
Given the recent studies showing the downsides of Pradaxa, it’s a wonder that the drug is still being marketed to patients. If you or a loved one has been seriously injured by a dangerous or defective drug, you should contact an experienced VA personal injury lawyer as soon as possible. Attorneys with our Virginia personal injury law firm have helped many victims of dangerous and defective drugs recover damages from companies whose negligence or disregard for consumer safety led to injuries.
If you or a family member has been injured by a defective or dangerous drug, you can begin to learn about your legal rights and options by reading this article.
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About the Editors: The VA-NC medical malpractice attorneys at Shapiro, Lewis & Appleton include medical and surgical malpractice lawyers licensed in both Virginia and Carolina. Our attorneys have experience handling medical malpractice cases involving hospital and doctors’ mistakes, as well as nursing home abuse and neglect. Check out our case results to see our track record of success in medical malpractice lawsuits, and also be sure to read our free medical malpractice reports Top 10 Tips From a Medical Malpractice Insider and Top 5 Surgical Errors. Rick Shapiro and James Lewis have been listed among the Best Lawyers in America since 2008. They, along with fellow attorney Randy Appleton, have also been named Virginia Super Lawyers since 2010, an honor fewer than 5 percent of outstanding attorneys receive.