The safety of the blood thinning medication Pradaxa has recently come into question as many experts have linked it to increasing patients’ risk for life threatening bleeding. In the first quarter of 2011 alone, the US Food and Drug Administration (FDA) received more than 500 reports of bleeding problems related to Predaxa, just months after the drug had been released into the market.
In a quarterly drug safety report, the Institute of Safe Medication Practices (ISMP), which records all severe, disabling and fatal drug incidents reported to the FDA’s MedWatch program, the amount of reported bleeding problems related to Pradaxa outnumbered all others monitored by the group.
Patients using Pradaxa that have experienced severe bleeding problems, hemorrhaging other issues may be eligible to pursue a Pradaxa lawsuit. Our Pradaxa attorneys are currently reviewing potential claims.
Pradaxa’s History in the Market
Dabigatran, better known by the name Pradaxa, was released as an anticoagulant in October 2010. However, within the first three months of its release, the FDA’s MedWatch adverse event reporting system received more consumer complaints in the first three-month period than 98.7 percent of other drugs.
Pradaxa was marketed as a replacement for warfarin and was purported to be easier to use, as it requires less monitoring. However, in the event of a serious bleeding problem, doses of Vitamin K can counteract the effects of warfarin. Pradaxa has no such remedy available to counteract its side effects in the event of internal bleeding.
During Pradaxa’s first year on the market, more than 500 deaths were attributed to the use of Pradaxa, causing some experts to question whether the drugs pre-approval trials were valid. Serious side effects of the drug include hemorrhaging, particularly in the elderly and individuals with impaired kidney function, and, in some cases, ineffectiveness, which resulted in deep vein thrombosis and pulmonary embolism from blood clots that Pradaxa failed to treat.
The FDA Investigates Pradaxa
Just 14-months after Pradaxa was released into the market, the FDA announced the launch of a safety review of the drug in December 2011. The agency is evaluating post-marketing reports of serious bleeding events. The investigation was initiated a month after manufacturer Boehringer Ingelheim announced it was investigating death reports associated with Pradaxa.
Due to the manufacturer’s potential failure to provide adequate warning of the risks inherent to taking Pradaxa, lawyers are evaluating whether patients could be entitled to compensation via a product liability lawsuit.