FDA Warns of Increased Risk for Cancer and Heart-related Issues Linked to Xeljanz and Xeljanz XR
FDA – A news story on healio.com reports that the U.S: Food and Drug Administration has issued a new safety warning concerning an increased risk for older patients to develop severe health-related complications and cancer caused by tofacitinib (Xeljanz) compared to TNF inhibitors. The FDA issued this safety alert warning to health providers and patients. The FDA alert recommends that healthcare providers weigh the costs and benefits associated with Pfizer’s Xeljanz (tofacitinib) when creating a treatment plan for patients with ulcerative colitis or rheumatoid arthritis.
According to the FDA, patients should not stop taking their medicine without first discussing their health professional issue because this could worsen their medical condition. Patients are advised to speak with the medical providers about any questions or concerns they have.
The FDA’s safety alert was based upon the preliminary results provided by ORAL Surveillance. The FDA required the post-marketing clinical trial to show non-inferiority of Xeljanz compared to TNF inhibitors among patients with rheumatoid arthritis with regards to risks of malignancies and cardiovascular events. The safety trial also examined other possible risks such as “blood clots in the lungs and death.”
The clinical trial results associated Xeljanz with a higher rate of malignancies and major adverse cardiovascular events when compared to TNF inhibitors in patients 50 years of age or older with underlying cardiovascular risk factors.
In February and July 2019, the U.S. Food and Drug Association warned that preliminary trial results showed an increased risk of blood clots and fatalities connected with the higher, twice-daily 10 mg dosage of Xeljanz and Xeljanz XR. The clinical trial result caused the FDA to require a Boxed Warning for tofacitinib’s prescribing information.
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