When the FDA first approved tofacitinib (the active ingredient in Xeljanz) in May 2018, the agency ordered additional clinical trials to determine the potential risk of heart problems, cancer, and life-threatening opportunistic infections in rheumatoid arthritis patients who take the drug.
The early trials were designed to assess the effects of tofacitinib at 2 separate dosages – 10 mg twice daily and 5 mg twice daily – in combination with methotrexate, and then compare the results against a different type of RA drug known as a tumor necrosis factor (TNF) inhibitor. Test subjects had to be at least 50-years-old and have at least 1 pre-existing cardiovascular risk factor such as smoking.
What’s the problem?
During the analysis of the recent trial, an external data safety monitoring committee found an unexpectedly high number of patients with pulmonary embolism and even death in patients treated with tofacitinib 10 mg twice daily, compared to patients treated with tofacitinib 5 mg twice daily or a TNF inhibitor.
What is Xeljanz?
Xeljanz (tofacitinib) is a prescription drug used to treat rheumatoid arthritis (RA), a chronic progressive disease that causes inflammation in the joints and painful deformity / immobility, most often in the fingers, wrists, feet, and ankles. Tofacitinib works by inhibiting a signaling pathway known as the “JAK pathway” inside cells associated with RA that cause inflammation.
Blood Clot Symptoms
Signs and symptoms of a pulmonary embolism may include:
- Sudden shortness of breath or difficulty breathing
- Chest pain or pain in your back
- Coughing up blood
- Excessive sweating
- Clammy or bluish colored skin
Xeljanz Black Box Warning
Xeljanz is required to carry a “black box” warning — the strongest warning available under U.S. law — regarding an increased risk of “serious infection leading to hospitalization or death; pulmonary and extrapulmonary TB, invasive fungal infections, and other opportunistic infections.” Most of these infections have been reported in conjunction with immunosuppressants; FDA advises physicians to screen for latent TB infection before and during treatment with Xeljanz.
Despite the risk of blood clot, pulmonary embolism, death and other serious side effects with Xeljanz, FDA cautions patients not to stop taking the medication without talking to their doctor first, as doing so could also result in adverse health consequences, including death. Patients who have any of the above symptoms after taking Xeljanz should call a doctor immediately.
“We are communicating now, given the serious nature of the safety issue, to ensure that patients taking tofacitinib are aware that the FDA still believes the benefits of taking tofacitinib for its approved uses continue to outweigh the risks,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
Xeljanz Side Effects
- Blood clots
- Pulmonary embolism (PE)
- Other cancers
- Opportunistic infections
- Extrapulmonary tuberculosis
- Invasive fungal infections
- Jaundice (yellowing of the eyes and/or skin)
- Skin rash
- And more