U.K. Officials OK Xarelto for Patients at Risk for Recurring Heart Attacks
U.K. regulators have given doctors the green light to prescribe the new-generation blood thinner, Xarelto, to patients who have already had a heart attack and may be at risk for another, FiercePharma.com reported last month.
In a guidance issued on October 22, the National Institute for Health and Care Excellence (NICE) cleared the medication for use in preventing blood clots in these individuals, citing 57,000 admissions for heart attacks in England between 2009 and 2010. During this time, 28,000 recurring heart attacks were also recorded. “People who have a heart attack are at higher risk for having further events,” said the NICE Health Technology Evaluation Centre Director. “Any additional treatments to reduce that risk are therefore to be welcomed.”
In the U.S., where Xarelto has still not been approved for patients with acute coronary syndrome (ACS), sales of the drug are continuing to skyrocket—with $1.09 billion sales through the first nine months of 2014, according to FiercePharma.com. In February, the U.S. Food and Drug Administration (FDA) sent a complete response letter to Johnson & Johnson that mentioned an advisory committee’s unanimous vote to deny its approval for use in ACS patients. Xarelto is jointly marketed by the healthcare giant’s subsidiary, Janssen Pharmaceuticals and Bayer Healthcare.
FiercePharma.com reports that ACS complications account for 1.1 million hospital admissions each year in the U.S., before noting Johnson & Johnson & Bayer’s plan to test Xarelto as a treatment for embolic stroke that occurred for undetermined reasons, and periphery artery disease.
Thousands of Xarelto Internal Bleeding Reports Filed in the U.S.
Meanwhile, thousands of patients in the U.S. have come forward to file adverse event reports that allege internal bleeding side effects of the blood thinner, which is designed similarly to Pradaxa. The Institute for Safe Medications Practices published the findings of an investigation in 2012 that reflected the filing of 2,000 adverse event reports related to Xarelto that year, many of which mentioning instances of internal bleeding. In the first quarter of 2013, the ISMP found 680 Xarelto complaints, which surpassed those associated with Pradaxa for the first time since its release two years earlier.
A number of Xarelto internal bleeding lawsuits have also been filed in the U.S. on behalf of individuals who allegedly suffered internal bleeding complications that may have turned fatal.
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