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Rheumatoid arthritis medication shouldn’t be approved by FDA, consumer group says

RheumatoidArthritis2Baricitinib, a medication that would be used to treat adults with rheumatoid arthritis, shouldn’t be approved by the U.S. Food and Drug Administration because it causes unique life-threatening harms and lacks any unique benefit over the similar FDA-approved medication tofacitinib, Michael Carome, M.D., director of Public Citizen’s Health Research Group, said Monday.

The FDA rejected the medication in April 2017 after concluding that it has an unfavorable risk-benefit profile. Data from randomized clinical trials show that baricitinib, which was developed by Eli Lilly and Co., can cause potentially fatal blood clots, a risk not seen with similar rheumatoid arthritis medications. The company resubmitted an application for approval of the product but didn’t provide any new data that alters the agency’s original conclusion.

Approval of baricitinib would show blatant disregard for the public health principles underlying the FDA’s regulatory authority, Carome said.

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