On February 29, 2019, the U.S. Food and Drug Administration (FDA) issued a safety communication warning the public about an increased risk of blood clots and death in patients with rheumatoid arthritis taking a high dose of Xeljanz (tofacitinib). The warning was prompted by a mandatory post-marketing safety trial of the drug. The trial is still ongoing, but the results were alarming enough for patients in the trial who were taking the high dose to be transitioned to a lower dose.
Safety Trial was a Condition of Approval
When the FDA approved Xeljanz for RA, in 2012, it required Pfizer to conduct the post-marketing safety trial as a condition. The trial was to evaluate the risk of cancer, opportunist infections and heart-related events in RA patients using the drug in combination with methotrexate. It was to evaluate those using Xeljanz at 5 mg twice daily and at 10 mg twice daily.
Xeljanz is not approved for use in RA at 10 mg, only at 5 mg, but doctors are allowed to prescribe off-label when they feel it is best for their patients. Xeljanz is only approved at the higher dose for patients with Crohn’s disease.
In addition to the possible increased risk of pulmonary embolism (PE), deep vein thrombosis (DVT), and death indicated by the safety trial, there is already a known risk of the following when taking Xeljanz:
- Infections serious enough to require hospitalization or be fatal
- Lymphoma, non-melanoma skin cancer, and other cancers
- Liver problems
- Perforations of the stomach or intestines
- Hypersensitivity reactions
If you or someone you love has suffered blood clots or a heart-related event while taking Xeljanz, please schedule a free consultation with an experienced product liability attorney right away to learn more about your rights.