Health

FDA warns about drugs for arthritis and ulcerative colitis

Washington – The US Food and Drug Administration has reported that the arthritis and ulcerative colitis drugs Xeljanz, Xeljanz XR (tofacitinib) have serious heart-related problems and cancer compared to another type of drug called Tumor Necrosis Factor (TNF). It warns the public about the increased risk. Inhibitor.

The FDA has called for safety studies and has also investigated other potential risks such as blood clots and death in the lungs. Those final results are not yet available.

“We will evaluate the results of clinical trials we have received and work with pharmaceutical companies to get more information as soon as possible,” the FDA said in a news release Thursday. “When the review is complete, or when we have more information to share, we will give you final conclusions and recommendations.”

The FDA stated that patients should not stop taking tofacitinib without first consulting a healthcare professional. This can make things worse.

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In the release, the FDA states:

“Tofacitinib was first approved in 2012 to treat adults with rheumatoid arthritis (RA) who did not respond well to methotrexate drugs. In RA, the body attacks their joints, causing pain, swelling, and Causes loss of function. In 2017, we approved tofacitinib to treat patients with rheumatoid arthritis (PsA), the second symptom that causes joint pain and swelling. These patients are methotrexate. And other similar drugs did not respond well. In 2018, we approved a treatment for ulcerative colitis, a chronic inflammatory disease that affects the colon. Tofacitinib activates the immune system. It works by lowering. Excessive immune system contributes to RA, PsA, and ulcerative colitis.

“Safety to manufacturer Pfizer to assess the risk of serious heart-related events, cancer, and infections in RA patients taking methotrexate when the FDA first approved tofacitinib. He requested that a clinical trial be conducted. In this study, two doses of tofacitinib (RA’s approved dose of 5 mg daily, compared to another type of RA drug called a TNF inhibitor) Two doses, and a higher dose of 10 mg twice daily) were studied. Patients who participated in the trial were at least 50 years old and had to have at least one cardiovascular risk factor. February 2019 And July 2019, Warns that the results of the mid-term study show that a twice-daily dose above 10 mg increases the risk of blood clots and death, and as a result, Framed warning For prescription information on tofacitinib. Clinical trials are now complete and early results show that patients with RA treated with both doses of tofacitinib have a greater incidence of heart-related events and cancer compared to patients treated with TNF inhibitors. It shows that it is high. The FDA is waiting for additional results from the exam.

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“We recommend that healthcare professionals and patients use the information in the Contact the FDA box at the bottom of the page to report side effects associated with tofacitinib or other medications to the FDA MedWatch program. To do.

“Healthcare professionals, patients, and consumers can sign up Email alert External link disclaimer About drug safety communication related to drugs of interest and specialized medical care. “

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