FDA issues safety risk on Pfizer’s Xeljanz, the most advertised product on TV

By PharmaCompass

2019-02-28

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The US Food and Drug Administration (FDA) this week issued an alert on Pfizer’s Xeljanz (tofacitinib). The agency said a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA).

The agency has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis.

Last month, Pfizer’s Xeljanz topped AbbVie’s Humira in terms of its advertising spend on national television. According to real-time TV ad tracker iSpot.tv, Pfizer spent more than US$ 40 million on national TV time, which was US$ 6 million more than Humira’s spend on the medium.

Meanwhile, a February 20 report published in Endpoints News mentioned that Pfizer has said RA patients taking a 10 mg dose of Xeljanz (tofacitinib) in an ongoing safety study are being moved to a 5 mg dose, “after the independent monitoring board determined that there was an imbalance in the rate of death between the 10 mg drug arm (twice daily) and both their 5 mg arm and a group taking a TNF inhibitor in the control group.”

During the past seven years, Xeljanz has emerged as one of Pfizer’s most important products —Xeljanz earned US$ 1.2 billion for Pfizer in the first nine months of 2018, up from US$ 935 million the year before, with markets for RA, psoriatic arthritis and ulcerative colitis, where the recommended dose is 10 mg.

FDA said “patients should not stop or change” the dose of tofacitinib without first talking to their healthcare professional, as doing so may worsen their condition.

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