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The new blood thinner Pradaxa has been linked to an increased risk of serious and potentially life-threatening bleeding, leading many to question its safety.
PRADAXA LAWSUIT STATUS: In May 2014, Boehringer Ingelheim and attorneys for plaintiffs reached a Pradaxa settlement agreement for $650 million, which would resolve about 4,000 Pradaxa bleeding lawsuits.
MANUFACTURER: Boehringer Ingelheim
OVERVIEW: Pradaxa (dabigatran) was released in October 2010 as an anticoagulant, but received more consumer complaints to the FDA’s MedWatch adverse event reporting system in its first three months on the market than 98.7% of the other drugs.
The drug is meant to be a replacement for warfarin and is supposedly easier to use because it requires less monitoring. However, warfarin can be quickly counteracted by doses of Vitamin K when a bleeding problem occurs. There is no such remedy available when Pradaxa side effects cause internal bleeding.
PRADAXA INTERNAL BLEEDING SIDE EFFECTS: In the first year Pradaxa was on the market, there were more than 360 deaths attributed to internal bleeding from Pradaxa and some experts have raised questions as to whether the drug’s pre-approval clinical trials were valid.
Complaints of Pradaxa problems have included hemorrhages, especially among the elderly and those with impaired kidney function. Other reports suggest that the drug has proven ineffective in some cases, leading to deep vein thrombosis and pulmonary embolism due to blood clots Pradaxa failed to treat.
While all blood thinners carry a risk of bleeding problems, there has been growing alarm over Pradaxa deaths and the high number of complaints of bleeding from doctors and patients.
In December 2011, the FDA announced it was launching a safety review of Pradaxa, after only 14 months on the market. The agency will evaluate post-marketing reports of serious bleeding events. The investigation came about a month after the manufacturer announced it was investigating Pradaxa death reports.
In March 2016, a Pradaxa reversal agent, Praxbind, became available to help doctors stop Pradaxa bleeding events.
FIND OUT IF YOU MAY QUALIFY FOR A PRADAXA LAWSUIT: As a result of the drug makers’ possible failure to adequately warn about the risks associated with their medication, Pradaxa lawyers are evaluating whether users may be entitled to compensation through a product lawsuit.
Submit information regarding a potential Pradaxa lawsuit to have your case reviewed and evaluated by an attorney. If it appears that you, a friend or family member may be entitled to compensation as a result of Pradaxa side effects, you may be contacted by a lawyer.