Report Says FDA Hastily Approved Pradaxa, Other Drugs Despite Safety Risks


Report Says FDA Hastily Approved Pradaxa, Other Drugs Despite Safety RisksOverview: The U.S. Food and Drug Administration’s (FDA’s) expedited approval process for drugs such as Pradaxa has exposed patients to unforeseen risks, according to a report published today in the Journal of the American Medical Association (JAMA). The anticoagulant, which was marketed as a warfarin replacement, has come under greater scrutiny over reports of irreversible bleeding and other serious side effects.

  • JAMA published a report highlighting the safety risks that come with expedited approval of a new drug; the review used Pradaxa, Gilenya and a cancer drug as examples
  • Pradaxa is an anticoagulant used to prevent strokes in patients with atrial fibrillation (AF)
  •  Pradaxa has been associated with bleeding risks such as irreversible gastrointestinal and cerebral hemorrhage

Product: Pradaxa (dabigatran)

Manufacturer: Boehringer Ingelheim Pharmaceuticals

Side Effects & Complications

  • Cerebral hemorrhaging
  • Gastrointestinal (GI) hemorrhaging
  • All types of bleeds including the intraspinal, intraocular, intraarticular (joints), retroperitoneal or pericardial areas

Report Says Speedy Approval Comes with Risks

For the fiscal year of 2011, the FDA approved 35 new drugs. According to the JAMA report, nearly half of these medications were approved for sale using some form of expedited or shortened review process. According to the authors, drugs like Pradaxa, Gilenya and a cancer treatment called Vendetanib were pushed onto the market with “limited clinical data and substantial risks”. They stated that “These examples raise the question of whether it was good policy to approve three innovative new drugs with significant safety questions unanswered,”

Janet Woodcock, who is the director of the FDA’s Center for drug evaluation and review, said “I’d like to stress that where there are unmet medical needs, the public has told us they are willing to accept greater risks,” according to the Wall Street Journal. Still, some side effects, such as the uncontrollable bleeding that can occur with Pradaxa, have left some wondering whether the speedy review process is worth the overall risk.

Pradaxa Side Effects

Pradaxa was approved in 2010 to prevent stroke in patients who have atrial fibrillation, a condition that causes irregular heart rhythm. The drug was meant to replace warfarin, an older drug that requires regular monitoring and dietary restrictions. Hailed as an innovative warfarin replacement upon approval, Pradaxa has since come under fire over the past year due to reports of cerebral, gastrointestinal and other types of hemorrhage. The main concern with these bleeding risks is that there is no way to stop the bleeding in a patient taking Pradaxa. Despite its setbacks, warfarin can be reversed with vitamin K or fresh frozen plasma.

The drug drew international concern when over 250 Pradaxa-related deaths were reported to the European Medicine Agency’s database last November. Shortly afterwards, the FDA began a safety review of the drug. According to the ISMP, the FDA received more adverse event reports over Pradaxa than any other drug last year. Pradaxa was cited in the greatest number of deaths, strokes, acute kidney failures and hemorrhages.