FDA Consumer Alert
Pradaxa® Blood Thinner Side Effects Lawsuit Information
Pradaxa® (generic name: Dabigatran) has been linked to serious, if not fatal, side effects:
- Pradaxa®is given to treat atrial fibrillation (a-fib) in order to prevent stroke and blood clots
- Pradaxa® has been linked to gastrointestinal (GI) bleeds and hemorrhagic strokes
- If a patient taking Pradaxa® develops any type of bleed, there is no antidote to stop bleeding
- Pradaxa® is not as safe or effective as the manufacturer has reported
- The Nations Law Firm will evaluate your case free of charge
WHAT IS PRADAXA®?
Pradaxa® (dabigatran etexilate) is used to prevent strokes and blood clots in patients with atrial fibrillation (irregular heartbeat). More than 2 million Americans have this condition which makes them prone to blood clots which can then travel to the brain causing a stroke. Pradaxa® works by inhibiting an enzyme involved in blood clotting.
If you or someone you know has suffered from internal bleeding, heart attack or other serious injury after taking Pradaxa, please contact us for a free case evaluation at 1-800-269-3050.
THE MORE CONVENIENT DRUG
Pradaxa® is manufactured by the German-based pharmaceutical giant, Boehringer-Ingelheim. What this company did not use in its aggressive marketing campaign is the fact that, unlike Warfarin®, severe bleeding caused by Pradaxa® can not be stopped by vitamin K injections. There is no antidote for Pradaxa® bleeding. When Pradaxa® was introduced, it was heralded as a potential replacement for the commonly-used anti-coagulant Warfarin. Although in studies Pradaxa® was not signifantly more effective than Warfarin® in preventing strokes or blood clots, the drug company promoted Pradaxa® as easier to use than Warfarin. According to the industry-funded researchers led by Dr. Sam Schulman of McMaster University and the Henderson Research Center in Hamilton, Ontario:
For patients and health-care providers, dabigatran is a far more convenient drug than warfarin because it has no known interactions with foods and minimal interactions with other drugs and therefore does not require routine blood-coagulation testing.
Pradaxa®, manufactured by Boehringer Ingelheim, has been heavily promoted as the new and improved alternative to Coumadin (Warfarin®). Both drugs reduce the risk of strokes and blood clots in patients with atrial fibrillation or irregular heartbeat.
As of November 6, 2011, the European Medicines Agency (equivalent of FDA in U.S.) was aware of 256 Pradaxa® patients who suffered fatal bleeding. Japan’s Health Ministry notified the drug company that from March to August 2011, they were aware of 81 elderly Pradaxa® patients experiencing severe hemorrhaging. In five of them, it was fatal. In the Fall of 2011, New Zealand officials reported 36 Pradaxa® patients suffering severe internal bleeding and at least five others who died from the hemorrhaging.
FDA SAFETY ALERT
The FDA issued a Safety Alert on December 7, 2011 to announce that it would be conducting a safety review of reports of serious bleeding events associated with Pradaxa® use. This was a little over a year after the FDA approved the drug. Serious bleeding is a known complication of all blood thinners and is warned about in the drug labels. The FDA will investigate to see if there are more serious bleeding events from Pradaxa® than expected or other problems which should be warned about.
If you or someone you know has suffered from internal bleeding, heart attack or other serious injury after taking Pradaxa®, please contact our offices for a free case evaluation with one of our attorneys. Our toll-free number is 1-800-269-3050.
*READ THIS IF YOU TAKE PRADAXA®
According to the FDA, patients with atrial fibrillation “should not stop taking Pradaxa® without talking to their healthcare professional. Stopping use of blood thinning medications can increase their risk of stroke.” Please talk to your doctor.