A blood thinner tied to life-threatening Xarelto internal bleeding injuries has received approval abroad to treat patients who may be at increased risk for heart attacks, FiercePharma.com reported in October.
A guidance issued last month by the National Institute for Health and Care Excellence (NICE) reflects the medication’s approval for the prevention of blood clots in people who have already had a heart attack and may be at risk for suffering another. The United Kingdom regulator said on October 22nd that 57,000 admissions for heart attacks had been recorded between 2009 and 2010, at which time 28,000 subsequent heart attacks were also noted. Following the NICE approval, its Health Technology Evaluation Center Director issued the following statement: “People who have a heart attack are at higher risk for having further events. Any additional treatments to reduce that risk are therefore to be welcomed.”
The U.K.’s recent blood thinner approval is noteworthy, given the numerous Xarelto lawsuit claims that have been filed in the U.S. by individuals who allege life-threatening episodes of internal bleeding that may have turned fatal. Plaintiffs in these cases accuse Bayer Healthcare and Johnson & Johnson, whose subsidiary, Janssen Pharmaceuticals, markets the medication, of failing to warn about its risks. There is no available reversal agent to stop internal bleeding episodes once they begin, Xarelto lawsuits point out. Thousands of adverse event reports filed with the U.S. Food and Drug Administration (FDA) have also been filed over the blood thinner. In 2012, the Institute of Safe Medication Practices found that 2,000 side effect reports of the medication had been filed, many of which involving episodes of internal bleeding.
Despite the mounting litigation involving Xarelto, sales of the blood thinner have continued to increase recently. In the first nine months of 2014, Xarelto turned a $1.09 billion profit, FiercePharma reports, but is still unavailable for patients with acute coronary syndrome (ACS). The FDA sent a complete response letter to Johnson & Johnson in February that reiterated its opposition to clear the drug for use in treating these patients, noting a unanimous vote against doing so by a federal panel of advisers. But that hasn’t slowed Johnson & Johnson’s cardiovascular research program for Xarelto—the company announced in September that they would be testing the medication’s effectiveness in treating embolic strokes that occurred for undetermined reasons.
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