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05-02-2021 | Rheumatoid arthritis | News

Regulatory update

FDA issues safety alert on risk for CV events, cancer with tofacitinib

Author: Claire Barnard


medwireNews: The US FDA has issued a Drug Safety Communication warning that the Janus kinase inhibitor tofacitinib may be associated with an increased risk for cardiovascular (CV) events and malignancy.

This alert follows the announcement of preliminary results from the ORAL Surveillance study, which demonstrated that rheumatoid arthritis patients treated with tofacitinib have higher rates of major adverse CV events and cancer than those given tumor necrosis factor inhibitors. The FDA-mandated safety trial also investigated other potential risks including all-cause mortality and pulmonary embolism, but the final results are not yet available for these endpoints.

The FDA is currently reviewing the available data and plans to issue recommendations following completion of the review. In the meantime, the agency recommends that healthcare professionals “should consider the benefits and risks of tofacitinib when deciding whether to prescribe or continue patients on the medicine,” and report any adverse events to the FDA MedWatch program.

This safety announcement comes after interim trial results in 2019 suggesting an increased risk for pulmonary embolism and death with the 10 mg twice daily dose of tofacitinib, and the subsequent addition of a boxed warning to the label.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group


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