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Signal of Increased Risk of Major Cardiovascular Events and Cancer with Tofacitinib

EMA’s Pharmacovigilance Risk Assessment Committee concluded review of a safety signal
21 Jun 2021
Epidemiology/Etiology/Cancer Prevention

At its June 2021 meeting, the European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended an update to the product information for tofacitinib (Xeljanz) to include a new recommendation for its use. The PRAC has concluded its review of a safety signal regarding major adverse cardiovascular events and cancer (excluding non-melanoma skin cancer).

The evidence is gathered from a recent study (A3921133) on this medicine conducted in patients who were 50 years of age or older with at least one additional cardiovascular risk factor. The PRAC is reminding healthcare professionals to carefully evaluate a patient’s individual benefit-risk profile when deciding to prescribe or continue the treatment with Xeljanz.

Xeljanz is used to treat adults with moderate to severe rheumatoid arthritis, psoriatic arthritis and ulcerative colitis.

As part of its advice on safety-related aspects to other EMA committees, the PRAC discussed direct healthcare professional communication (DHPC) containing important safety information for Xeljanz. This DHPC is intended to inform healthcare professionals about the outcome of a signal procedure and new recommendations for use of Xeljanz.

Final results from a recently completed study (A3921133) showed an increased risk of major adverse cardiovascular events and cancer in some patients, compared with TNF-alpha inhibitors.

The PRAC is therefore advising healthcare professionals that Xeljanz should only be used in patients over 65 years of age, patients who are current or past smokers, patients with other cardiovascular risk factors, and patients with other malignancy risk factors, if no suitable treatment alternative is available.

The DHPC for Xeljanz will be forwarded to EMA’s Committee for Medicinal Products for Human Use (CHMP). Following the CHMP decision, the DHPC will be disseminated to healthcare professionals by the marketing authorisation holder, according to an agreed communication plan, and published on EMA’s website and in national registries in EU Member States.

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