Increased Risk of Blood Clots and Death Seen with Higher Dose Tofacitinib

The FDA has issued a safety communication for twice daily 10-mg tofacitinib (Xeljanz and Xeljanz XR). A clinical trial has found an increased risk of pulmonary blood clots and death when this dosage is used to treat rheumatoid arthritis (RA).

This higher dosage of tofacitinib is not approved for use in RA, and is approved only for treatment of ulcerative colitis.

The agency is recommending that healthcare professionals follow recommendations in the prescribing information for the specific condition being treated. Patients should be monitored for any symptoms of pulmonary embolism, such as shortness of breath or chest pain, and warned to seek medical attention if they experience any symptoms.

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The finding came about because when the FDA approved tofacitinib it required a clinical trial of patients with RA to evaluate the risk of cardiac-related events at two doses, 10 mg twice a day and 5 mg twice a day in conjunction with methotrexate. Treatment was compared to data with use of a tumor necrosis factor inhibitor. The RA patients in the trial were at least 50 years old and had at least one cardiovascular risk factor.  An analysis of data from the trial found an increased occurrence of blood clots in the lungs and death in patients treated with tofacitinib 10 mg twice daily compared to those treated with tofacitinib 5 mg twice daily or with a TNF inhibitor.

The clinical trial is ongoing and is expected to be completed by the end of this year.