Patient Safety News: Makers of Xarelto misled medical journal, NYT reports

The makers of the anti-clotting medication Xarelto are under fire this week for allegedly misleading the editors of a prestigious medical journal, the New England Journal of Medicine.

In a scathing New York Times article, reporter Katie Thomas explains that a letter published in the NEJM failed to include critical laboratory data that was gathered by pharmaceutical companies Bayer and Johnson & Johnson. Lawyers for thousands of patients suing the drugmakers over the safety of Xarelto say the failure to include the data is evidence of deception.

The allegation raises new questions about the approval process for Xarelto, which was approved by the United States Food and Drug Administration (FDA) in 2011 after a fast-track regulatory review, despite the fact that some of the agency’s own scientists had concerns about its safety.

Susan Faunce, an attorney at Berman & Simmons who handles cases involving dangerous drugs and medical devices, is accepting clients who took Xarelto and suffered harm. Faunce said concerns about the NEJM letter are deeply troubling for consumers who deserve transparency and full disclosure from drugmakers.

“These are the type of omissions that make it very hard for the public to trust the pharmaceutical industry,” Faunce said. “We’d like to think that we are past the days when drugmakers concealed or altered data for their own gain. But this situation shows us once again that we must serve as watchdogs for these corporations, and hold them accountable when necessary.”