FAA Still Concerned About Pradaxa Side Effects

Washington, DCConcerns about the risk of Pradaxa side effects have resulted in the Federal Aviation Administration (FAA) refusing to allow Pradaxa on the list of approved medications. Pradaxa bleeding is the main cause of concern, according to the FAA, and is also a concern for experts who monitor the drug. Pradaxa, known generically as dabigatran, has been linked to uncontrollable bleeding, for which there is no antidote.

In its newsletter from the first quarter of 2012, the FAA notes that it has received numerous inquiries about adding Pradaxa to its list of approved drugs. "Pradaxa was approved by the FDA [Food and Drug Administration] in October 2010, but because of reports of increased bleeding incidents, the FAA is waiting until October 2012 before reconsideration of approval for use by airmen."

The concern about Pradaxa is a the risk of uncontrolled bleeding. Pradaxa is an anticoagulant and a common side effect of anticoagulant medications is uncontrolled or unstoppable bleeding. In the case of warfarin (sold under the brand name Coumadin), a different anticoagulant, vitamin K can be used to stop internal bleeding. Pradaxa, however, has no current antidote. This means even a minor injury or fall could become fatal if the patient suffers internal bleeding or intracranial hemorrhage.

Pradaxa was given a speedy approval by the FDA and was marketed as being superior to warfarin. In December 2011, however, the US FDA issued a Drug Safety Communication about Pradaxa, warning that there was a risk of serious bleeding events associated with the medication, including fatal events. The FDA has also ordered a post-market review of Pradaxa's safety, although the agency has not pulled the drug from the market and says it believes Pradaxa provides health benefits for some patients.

Warfarin, despite having an antidote for bleeding incidents, interacts negatively with many other drugs.

Lawsuits have reportedly been filed against Boeringer Ingelheim, the maker of Pradaxa, alleging patients died because of unstoppable bleeding associated with the use of Pradaxa. The lawsuits allege Boehringer Ingelheim did not adequately warn patients and medical professionals about the risk of uncontrolled bleeding and the lack of any antidote.