In Feb. 2019, the U.S. Food and Drug Administration (FDA) alerted the public about the link between rheumatoid arthritis (RA) medication tofacitinib (Xeljanz®, Xeljanz XR®) and a greater risk of developing blood clots in the lungs and even death when exceeding a 5 mg twice-daily dosage.
The FDA required Xeljanz’s manufacturer, Pfizer Inc., to conduct a safety clinical trial of the medication when it approved the drug to treat RA in 2012. An external data safety monitoring committee reviewed information from that trial and discovered that ulcerative colitis patients who take 10 mg twice-daily doses have a higher risk of blood clots in their lungs and death than patients who take FDA-approved 5 mg twice-daily doses.
New, More Stringent FDA Warning Issued in July 2019
In July 2019, the FDA approved a “Boxed Warning” for 10 mg twice-daily doses of tofacitinib (Xeljanz, Xeljanz XR), which is commonly used to treat ulcerative colitis, after reviewing data from an ongoing safety clinical trial involving RA patients using the drug. This is the most prominent warning issued by the FDA and is only issued to drugs with serious or life-threatening side effects.
The FDA also mandates that the use of tofacitinib in patients with ulcerative colitis will now be limited to those whose conditions fail to respond to other medications or those who experience severe side effects with other treatments.
Watch for These Symptoms if You Take Xeljanz®
Get medical treatment as soon as possible if you or someone you love experiences these symptoms while taking Xeljanz:
- Sudden shortness of breath or difficulty breathing
- Chest pain or back pain
- Coughing up blood
- Excessive sweating
- Clammy or bluish colored skin
If you currently take Xeljanz for RA or ulcerative colitis, don’t discontinue the medication without talking to your doctor about alternative treatments, as stopping the drug could be harmful.
Get Experienced Legal Representation for Your Xeljanz® Complications
Prescription medications are supposed to treat illnesses by easing symptoms and promoting recovery. But some medications like Xeljanz put patients at risk of serious complications, including blood clots, pulmonary embolism, deep vein thrombosis, and even an increased risk of death.
If you or someone you love suffered serious health complications after taking Xeljanz, you shouldn’t have to pay for the resulting medical expenses out of pocket. Our law firm wants to help you get the compensation you deserve for what you’ve been through. Contact us today for a free consultation.
Xeljanz® and Xeljanz XR® are registered trademarks of Pfizer Inc. and are used here only to identify the products in question.
This law firm is not associated with, sponsored by, or affiliated with Pfizer Inc. or the U.S. Food and Drug Administration.
Do not stop taking a prescription medication without first consulting with your doctor. Discontinuing a prescribed medication without your doctor's advice can result in injury or death.
Cases may be referred to another attorney or law firm.