In October 2010, the U.S. Food and Drug Administration approved a prescription medication manufactured by Boehringer Ingelheim Pharmaceuticals under the brand name Pradaxa. (The chemical name for the medication is dabigatran etexilate mesylate.)
Pradaxa is a blood thinner used specifically in patients who suffer from non-valvular atrial fibrillation, a condition in which the organ’s two upper chambers beat irregularly or “flutter.” It places patients at an increased risk for stroke, which Pradaxa, as a direct thrombin inhibitor helps to prevent by lowering the chance of clotting.
Internal Bleeding with No Viable Treatment
Within three months of its introduction to the market in the U.S., Pradaxa was prescribed to about 86,000 individuals, with the standard caution of this class of drugs that internal bleeding can occur. Pradaxa was judged to be safer than the older, more standard Warfarin, which has a history of adverse food reactions. When Warfarin causes bleeding, however, Vitamin K will treat the issue. There is, at present, no viable treatment for bleeding in Pradaxa patients.
Other side effects associated with Pradaxa in addition to excessive internal bleeding include:
- excessive external bleeding,
- pain and swelling in the joints,
- dizziness,
- nausea and other gastrointestinal distresses.
FDA Review of Pradaxa
On December 7, 2011, the FDA issued a Drug Safety Communication for Pradaxa, saying the medication is under review in light of reports of fatal bleeding, but the source of those reports was not disclosed.
If you or a member of your family has had an adverse experience with Pradaxa, you may have the basis for a Pradaxa lawsuit. Only a qualified personal injury attorney can adequately evaluate your case, but you may be entitled to compensation from the drug’s manufacturer.