Xeljanz Blood Clot Risk: New Black Box Warning

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FDA Approves Boxed Warning for Xeljanz

The ulcerative colitis medication Xeljanz now carries a black box warning due to increased risks of blood clots and death when taking high doses of the drug. The U.S. Food and Drug Administration issued a new safety communication on July 26 informing patients and doctors about the changes in labeling. This comes roughly five months after the FDA first warned about the drug’s risks. 

xeljanz black box warning

Xeljanz triggered a warning from the FDA back in February 2019 after a clinical trial showed an increased risk of blood clots in the lungs in patients with rheumatoid arthritis (RA) taking 10 mg doses twice a day. This high dose of Xeljanz is only approved to treat patients with ulcerative colitis. 

Now, the FDA is warning patients taking the 10 mg dose for ulcerative colitis may also be at increased risk of blood clots and death. As a result, the agency limited the drug’s use in certain populations, and approved a boxed warning for the Xeljanz label. 

Black box warnings are the FDA’s strictest warnings for drugs and indicate that there is a serious risk of injury or death related to the drug. It is the final warning before a drug is taken off the market.  

The FDA’s July 26 safety communication provides more information about the new boxed warning. The initial February safety communication can be found here

Xeljanz Blood Clot Lawsuits

Patients who took Xeljanz and developed blood clots in the lungs and other serious side effects are filing lawsuits against the maker of the drug, pharmaceutical giant Pfizer. 

If you or someone you love was injured after taking Xeljanz, you may be entitled to financial compensation. Call the experienced Xeljanz attorneys at Schmidt National Law Group today at 1-800-631-5656 to see if you qualify for a Xeljanz Blood Clot Lawsuit