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FDA Pradaxa Internal Bleeding Warning

Pradaxa FDA Warning

On December 7, 2011, the FDA issued a Safety Communication on Pradaxa (dabigatran etexilate mesylate). The document notes that the drug’s tendency to cause severe bleeding events was known from the time Pradaxa was approved for use in the U.S., but post market reporting suggests that serious Pradaxa bleeding events may be more common than expected. Between October 2010, when the drug was released in the U.S., and August 2011, the FDA reports that of the estimated 371,000 Pradaxa users, 1,583 reported gastrointestinal hemorrhage and 466 reported vascular hemorrhage.

Pradaxa Internal Bleeding Warning Expanded on Packaging

The FDA has initiated a study to better understand the health risks of taking Pradaxa. As a result of this safety warning, Boehringer Ingelheim was required to expand the Pradaxa internal bleeding warning on the drug’s packaging. These signs indicate that Pradaxa may in fact not be safe for general use.

Pradaxa was first approved by the FDA in 2010 for the treatment of people with atrial fibrillation and are at risk for stroke. Strokes are dangerous and even deadly, and blood thinning drugs such as Pradaxa are prescribed to lower the risk of stroke.

Pradaxa was intended to replace warfarin, another blood thinner. Pradaxa initially received a warm reception from the medical community, but many doctors are skeptical based on the large number of Pradaxa internal bleeding deaths reported around the world. Federal drug safety regulators in Japan and Australia have issued safety warnings about Pradaxa, and Boehringer Ingleheim has confirmed that 260 Pradaxa internal bleeding deaths took place between March of 2008 and October of 2011 around the world. Clearly, Pradaxa poses serious risks to consumers, but the drug is still in wide use in the United States.

Initial clinical testing involved 18,000 patients, the FDA report says, and compared the effects of Pradaxa to the side effects of warfarin. This testing showed that Pradaxa was more effective at lowering the risk of stroke, and posed a comparable risk of bleeding problems. But the FDA’s new study is based on an assertion that Pradaxa may actually be more dangerous than warfarin drugs such as Coumadin. Indeed, many deaths have been reported as a result of Pradaxa internal bleeding. A Pradaxa lawsuit can provide compensation for the families of people who have died, through no fault of their own, as a result of taking Pradaxa.

Despite Internal Bleeding Risks, Patients Advised to Keep Taking Pradaxa

The 2011 FDA Pradaxa Safety Communication includes information for patients currently taking Pradaxa. Patients are advised to continue taking the drug unless their doctor changes the prescription. Not taking anything to prevent blood clotting can lead to a higher risk of stroke. The FDA document also lists warning signs of bleeding problems. However, even if bleeding problems are detected early, there is little doctors can do to stop the bleeding. To date, there is no antidote to Pradaxa; serious cases of Pradaxa internal bleeding are often untreatable. This is one of the reasons many countries are warning against Pradaxa use.

Pradaxa Internal Bleeding Risk Factors

Risk factors for serious bleeding events related to Pradaxa include age (persons age 75 or older are at the highest risk) and renal functioning (previously compromised renal function increases the risk of severe bleeding incidents). But even persons taking Pradaxa without these qualities may be at risk for life threatening internal bleeding. To better understand whether you have grounds for a Pradaxa internal bleeding lawsuit, contact a Pradaxa lawyer for a free consultation.