Citing data gathered from an ongoing clinical trial, the United States Food and Drug Administration has issued a black box warning for Pfizer’s rheumatoid arthritis and ulcerative colitis medication Xeljanz. The warning, the agency’s most severe, also applies to the extended release version of the drug, Xeljanz XR.
The warnings stem from the discovery of an increased risk of blood clots and the death of the patient when taking the twice-daily 10-milligram dose of tofacitinib; Xeljanz’s clinical drug name. In addition, the warnings now allow the use of Xeljanz to treat ulcerative colitis only in cases where the patient was not successfully treated by other medications or where those medications led to severe side effects.
Patients are advised by the agency not to discontinue their use of the medication in light of the new warnings. However, patients should be aware of the signs and symptoms of a blood clot and to seek immediate medical attention if they develop any of those symptoms.
Blood clots can cause sudden shortness of breath and pain in the chest that gets worse with breathing. In addition, a limb that is affected by a clot may be swollen or painful or tender to the touch. The skin can become tight and discolored as well. Blood clots are especially dangerous because of their ability to break free and travel through the body’s blood vessels and into the lungs or heart. Such occurrences are life-threatening and can very easily become lethal.
Patients taking the 5-miligram dose of Xeljanz have not, as of yet, exhibited a similar propensity for the development of blood clots. However, the data continues to be monitored and that study is ongoing. Patients with questions about the new warning for Xeljanz are strongly encouraged to discuss their concerns with their doctors.