FDA responds to safety signal reported in a post-marketing trial required for Xeljanz



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SPRING MONEY, Md., February 25, 2019 / PRNewswire / – "Today, the FDA warns of a safety signal that has emerged in a mandatory post-marketing trial of the drug Xeljanz (tofacitinib) in patients with rheumatoid arthritis. (5 mg twice daily or 10 mg twice daily) compared to the control group of another treatment and was specifically designed to assess the risk of cardiovascular, cancer and other events. Opportunistic infections.Data review by the Data Safety Monitoring Board of the study identified a safety signal The test sponsor, Pfizer, took immediate steps to protect the safety of the patients. Patients and patients in transition from the current trial immediately took pulmonary embolism and increased overall mortality in patients taking the 10 mg dose of tofacitinib tofacitinib 10 mg twice daily. day at 5 mg two tofacitinib, corresponding to the FDA-approved dose for adult patients with rheumatoid arthritis ", stated Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "The FDA is actively reviewing the trial data and working directly with Pfizer to better understand the safety signal, its impact on patients and the proper use of tofacitinib." The agency will take action appropriate, to ensure that patients enrolled in this trial and others are protected and that health care professionals and clinical trial researchers understand the risks associated with this use.We are communicating now, given the seriousness of the safety issue, to ensure that patients taking tofacitinib are aware that the FDA still believes the benefits of taking tofacitinib for its approved uses continue to outweigh the risks. approved uses should continue to take their medications as directed by their health professional. "Today's security alert underscores the importance of monitoring and resolving security issues that arise in the post-trade environment."

Today, the FDA issued a drug safety communication warning health professionals and patients of a safety signal observed in a post-marketing trial in patients with rheumatoid arthritis (RA) taking 10 mg of tofacitinib twice a day. The FDA has asked the drug manufacturer, Pfizer, to conduct the test when it approved tofacitinib in 2012. This ongoing trial evaluates the safety of tofacitinib at two doses (5 mg approved twice daily and a higher dose). 10 mg twice daily) compared to a tumor necrosis factor (TNFi) inhibitory control group. Data review by the Data Safety Monitoring Board revealed a safety sign of pulmonary embolism and an increase in overall mortality in the treated group at 10 mg twice daily. In the current trial, Pfizer has increased from tofacitinib to tofacitinib 5 mg tofacitinib twice daily, corresponding to the FDA-approved dose for adult patients with rheumatoid arthritis. moderate to severe. The 10 mg twice daily dose of tofacitinib is not an FDA approved dose for rheumatoid arthritis but is approved in the dosing schedule for patients with ulcerative colitis. The postmarketing trial was designed to evaluate the risk of cardiovascular (CV) events, opportunistic infections and malignancies, and patients had to be at least 50 years old. and present at least one CV risk factor to participate in this study.

Postmarketing studies play a vital role in the FDA's efforts to ensure the safety of FDA approved drugs and products. They may allow further assessment of potential safety issues or a better characterization of risk factors for known problems. These studies provide vital information on the safety of the FDA-approved treatment so that it can help ensure that the benefits to the affected patients outweigh the risks. The FDA provides advice and monitoring to companies to ensure that studies are completed safely and on time. When significant safety concerns arise, the FDA quickly employs them to prevent further injuries or deaths.

Xeljanz is approved for the treatment of certain adults with moderate to severe rheumatoid arthritis, active psoriatic arthritis and moderate to severe ulcerative colitis. Patients treated with Xeljanz have an increased risk of acquiring serious infections that may result in hospitalization or death. The most common serious infections reported with Xeljanz include pneumonia, cellulitis, shingles, urinary tract infection, diverticulitis and appendicitis.

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The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety of food products, cosmetics, dietary supplements, products emitting electronic radiation and the regulation of tobacco products.

Media Ask for information: Amanda Turney, 301-796-2969, [email protected]

SOURCE US Food and Drug Administration

Related Links

http://www.fda.gov

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