The FDA issued a safety alert Feb. 25 warning that a 10 mg, twice-daily dose of tofacitinib—sold under the brand names Xeljanz and Xeljanz XR—has been linked to an increased risk of pulmonary embolism and death in patients with rheumatoid arthritis. That dose is only approved for patients with ulcerative colitis, the agency said.
The medication was first approved following a clinical trial of patients with rheumatoid arthritis (RA) to evaluate the risk of cardiac events, cancer and opportunistic infections at two doses in combination with methotrexate compared to a tumor necrosis factor (TNF) inhibitor. All patients in the trial were at least 50 years old with one or more cardiovascular risk factor.
“During the most recent analysis of the trial, an external data safety monitoring committee found an increased occurrence of blood clots in the lungs and death in patients treated with tofacitinib 10 mg twice daily compared to patients treated with tofacitinib 5 mg twice daily or a TNF inhibitor,” the FDA noted.
The agency recommends providers use this prescribing information to guide treatment decisions, monitor patients for signs and symptoms of pulmonary embolism and advise them to seek medical attention if they experience the following:
- Sudden shortness of breath or difficulty breathing
- Chest pain or pain in your back
- Coughing up blood
- Excessive sweating
- Clammy or bluish colored skin
The FDA also suggested patients continue using tofacitinib until speaking with a healthcare professional because stopping or changing dosages on their own could worsen the condition. Healthcare providers and patients are also encouraged to report adverse events through the FDA’s MedWatch program.
Daniel joined TriMed’s Chicago editorial team in 2017 as a Cardiovascular Business writer. He previously worked as a writer for daily newspapers in North Dakota and Indiana.