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article imageBayer facing lawsuits in U.S. over anti-clotting drug Xarelto

By Karen Graham     Jun 14, 2014 in Health
The Frankfurter Allgemeine Zeitung news reported on Saturday that Germany's Bayer AG pharmaceutical company will be facing its first lawsuits in the U.S. this year over its anti-clotting drug, Xarelto, one of its top-five money makers.
According to the paper, an insider with the company is saying there are fewer than 10 lawsuits so far, but gave no details on the suits. At the same time, a company spokesman for Bayer declined to comment on the story, but did say the company stands behind the drug's safety profile.
The spokesman said that since Xarelto's launch, the safety profile has been consistent with the results of clinical studies done on over 75,000 patients. Xarelto sales in Europe hit 949 million euros ($1.3 billion) last year, and Bayer's chief executive officer, Marijn Dekkers says the company expects sales to reach 3.5 billion Euros annually.
Last month, Boehringer Ingelheim, the maker of Dabigatran, or Pradaxa, another anti-clotting drug, said it would pay $659 million to settle all the 4,000 U.S. lawsuits claiming injuries from severe and often fatal bleeding as a result of taking the medication after it was approved by the U.S. Food and Drug Administration in October 2010.
Rivaroxaban, or Xarelto was first approved by Health Canada in September 2008 to be marketed for use in people undergoing elective total hip replacement or total knee replacement surgery as a preventive medication in preventing venous thromboembolism, or blood clots.
It wasn't until July 1, 2011 that the FDA approved Xarelto for use as a preventative medication for deep vein thrombosis in patients going through knee or hip-replacement surgery. On November 2, 2012, the FDA expanded its approval to include the drug being used for DVT, as well as pulmonary embolisms and also as a preventative for those occurrences.
As for incidents reported to the FDA: In 2011 and in 2012, adverse effects involving the use of Pradaxa, Xarelto and warfarin were the most frequently cited anti-coagulants in reports to the FDA. A total of 582 deaths was reported from the use of Pradaxa, 151 deaths from Xarelto and 56 with warfarin.
In Germany alone, the number of side-effects from Bayer's Xarelto appear to be increasing, despite the comment from the company's CEO on Saturday, and many doctors have grown wary of using it any longer. In the first eight months of 2013, German regulators received 968 reports of side effects, including 72 deaths. This is a definite increase over 2012, when a total of 750 adverse reactions were reported, including 58 deaths, in Germany.
It should also be noted that it is dangerous to stop Xarelto without adequate anti-coagulation alternatives because of the increased risk of thrombotic events (strokes or blood clots). It should also be noted that Xarelto actually causes an increased risk for serious and even fatal bleeding episodes. It must be said though, that with many of the newer anti-clotting drugs today, there may have an increased risk of gastrointestinal bleeding in patients.
More about Xarelto, Bayer AG, Germany, Boehringer Ingelheim, pradaxa
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