March 2020: UK Drug Regulator MHRA Issues Safety Guidance And New Measures To Minimize Risks For Certain Patients
We have written about Xeljanz drug safety several times in the past, with an emphasis on the risk of Xeljanz-related blood clots. Now there is some focus being put on a clinical trial finding which shows Xeljanz increases infection risks, with pneumonia, cellulitis, herpes zoster, and urinary tract infections being pointed out as possible Xeljanz side effects.
For some background on the Xeljanz-related blood clots issue, you can read our previous articles:
- "Xeljanz Recommended Dosage For Ulcerative Colitis Patients May Increase Risk Of Pulmonary Embolism", posted in February 2019; and,
- "European Medicines Agency (EMA) Warns Xeljanz Increases Risk Of Pulmonary Embolism (PE) And Deep Vein Thrombosis (DVT)", posted in November 2019
More recently, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) published this report, "Tofacitinib (Xeljanz▼): new measures to minimise risk of venous thromboembolism and of serious and fatal infections", in the March 2020 edition of their Drug Safety Update publication.
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As it is that clinical trial finding Xeljanz increases infection risks which is relatively new, we will focus on this aspect of the MHRA Xeljanz Drug Safety Update report. In relevant part, here is what is being pointed out:
[Xeljanz (tofacitinib)] is known to increase the risk of serious and fatal infections such as pneumonia, cellulitis, herpes zoster, and urinary tract infections. Existing advice contraindicates use of [Xeljanz (tofacitinib)] in patients with active infections, and advises healthcare professionals to consider the benefits and risks in patients with recurrent infections, a history of serious or opportunistic infection, or travel to areas of endemic mycoses, and in those who have underlying conditions that may predispose them to infection.
Study A3921133 showed incidence of non-fatal serious infections to be higher in patients with rheumatoid arthritis receiving [Xeljanz (tofacitinib)] than in those receiving a TNF inhibitor (see letter for study data). The risk of serious infections and fatal infections was further increased in older patients aged 65 years or older, as compared to younger patients (aged 50–64 years) – see letter for data.
We will continue to watch for significant Xeljanz drug safety developments in the medical literature and the drug regulatory realm.
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