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Higher Dose Of Xeljanz Tied To Blood Clots In Lungs, Death In RA Patients

There is an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of Pfizer Inc's (PFE) Xeljanz or Xeljanz XR is used in patients with rheumatoid arthritis, warns the FDA.

The FDA has not approved the 10 mg twice daily dose of the drug for rheumatoid arthritis. Only 5 mg twice daily of Xeljanz and 11 mg once daily of Xeljanz XR are approved for rheumatoid arthritis. The same dosing regimen is approved for the treatment of adult patients with active psoriatic arthritis also.

Ulcerative colitis is another indication for which Xeljanz is approved, and the dosing regimen for this indication is 10 mg twice daily of Xeljanz.

The FDA insists that the health care professionals follow the recommendations in the Xeljanz or Xeljanz XR prescribing information for the specific condition they are treating; monitor patients for the signs and symptoms of pulmonary embolism, and advise them to seek medical attention immediately if they experience them.

Xeljanz/Xeljanz XR brought home annual sales of $1.77 billion for Pfizer in 2018, up 32% over the prior year.

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