Having been approved by the FDA about two years ago, the prescription drug, Pradaxa, continues to make headlines–but not in a good way. Pradaxa (also known as Dabigatran) is one of the newest drugs to be used to prevent strokes or serious blood clots in people who have atrial fibrillation (a condition in which the heart beats irregularly, increasing the chance of clots forming in the body, and possibly causing strokes).
The reported side effects stemming from the use of the drug since its approval by the FDA have been shocking. Research has revealed that Pradaxa exceeds all other monitored drugs in a number of categories, including the number of deaths (542), strokes (644), and overall total number of reports (3,781). The FDA initially approved the drug largely on the basis of a RE-LY study that was conducted with about 18,000 patients. That study clearly demonstrated that Pradaxa successfully lowered the risk of stroke and embolisms by about 35% more than the drug, Warfarin. Sadly, only six short months after the FDA’s approval, the manufacturer of the drug reported that as many as 250 deaths at that time were possibly linked to the use of Pradaxa.
Seek Legal Advice if You or a Loved One Has Used Pradaxa
In 2011, the FDA received, on a monthly basis, 315 reports regarding Pradaxa’s severe or fatal drug reactions. That is just about 10 reports a day for only its first full calendar year on the market. Unfortunately, that trend may continue in 2012; however, you do not have to face the possible dangers alone.
If you or someone you love has been the victim of a personal injury or accident, please contact Gersowitz, Libo & Korek, P.C. personal injury lawyers serving injured victims in New York and New Jersey at 800-LAW-9997.