U.K. Health Agency Backs Pradaxa, Despite Bleeding Risk

by NadrichCohenLLP on March 16, 2012

The U.K.’s top medical-cost regulator is putting its support behind Pradaxa for the prevention of blood clots in patients who suffer from a heart rhythm condition known as atrial fibrillation (AF). The announcement comes as concerns continue to mount over the safety of Pradaxa, which has been linked to numerous serious and in some cases, fatal, bleeding events.

The National Institute for Health and Clinical Excellence (NICE) called Pradaxa “a useful alternative option” for patients who would otherwise be given warfarin, another anticoagulant drug, to combat atrial fibrillation symptoms. Patients with AF experience a cardiac irregularity which can potentially cause blood clots to form around the heart. Warfarin has previously been linked to excessive bleeding and negative interactions with certain foods and alcohol.

According to the Daily Mail, the NICE says Pradaxa is a more cost-effective treatment option than warfarin and that the drug could potentially prevent up to 5,000 strokes per year. Patients who use Pradaxa also don’t have to worry about interactions with certain foods or undergoing regular monitoring to check for potential bleeding reactions.

Pradaxa (dabigatran) was first in approved in the U.S. in 2010. In December 2011, the U.S. Food and Drug Administration announced that it would conduct an ongoing safety review of Pradaxa after receiving numerous reports of patients experiencing serious bleeding events after taking the drug. In October 2011, Boehringer Ingelheim, the maker of Pradaxa, acknowledged that the drug has been linked to approximately 260 deaths worldwide.

Earlier this month, a group of researchers in New Zealand announced the results of a two-month review of Pradaxa, which indicated the bleeding risk tended to be higher among elderly patients, those experiencing moderate to severe renal failure and patients with a low body weight. A group of doctors in Utah also recently announced the publication of a case study involving Pradaxa in the Journal of Neurosurgery. The case study, which centered on an elderly Pradaxa user who died of a massive brain hemorrhage after a minor fall, suggested that the man’s death may have been caused by the drug.

What are believed to be the first federal Pradaxa lawsuits were filed last week in Tennessee, Kentucky and Louisiana. The lawsuits allege that not only did Pradaxa cause serious bleeding events but that Boehringer was aware of the risk but failed to adequately warn consumers of the dangers. One of the suits was filed by a woman who claims her mother died of a severe gastrointestinal bleed just three months after she began using Pradaxa.

Both the FDA and the NICE encourage patients to speak with their doctors about the potential risks of using Pradaxa prior to taking the drug. Patients who believe that they suffered a serious bleeding event caused by Pradaxa are also urged to speak with an experienced Pradaxa injury attorney to determine whether they may also be eligible to file a claim for compensation.



Nadrich & Cohen, LLP is a national law firm specializing in representing victims who've been injured by defective medical devices, harmful prescription drugs, faulty products, transportation accidents and dog bites. For more information, visit http://www.personalinjurylawcal.com.

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