Drug used to treat arthritis may cause serious heart problems, cancer, FDA warns

Recalls And Warnings

FILE – This Aug. 2, 2018, file photo shows the U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency’s campus in Silver Spring, Md. In a report to Congress and an accompanying “playbook” for states and localities, key federal health agencies and the Defense Department sketched out complex plans for a vaccination campaign to begin gradually early next year or later in 2020, eventually ramping up to reach any American who wants a shot. The Pentagon is involved with the distribution of vaccines, but civilian health workers will be the ones giving shots. (AP Photo/Jacquelyn Martin, File)

PROVIDENCE, R.I. (WPRI) — A medication commonly prescribed to patients suffering from rheumatoid arthritis or ulcerative colitis may cause serious health problems, according to the Food and Drug Administration (FDA).

The FDA said Xeljanz, also known as tofacitinib, can increase a patient’s risk of developing serious heart-related problems and cancer, specifically in those being treated for rheumatoid arthritis.

The FDA said Thursday preliminary results from a safety clinical trial of Xeljanz, which compared it to a similar type of medication, revealed the potential risks.

The safety clinical trial was requested by the FDA, which also investigated other potential health risks including blood clots in the lungs and death, though the final results are not yet available.

In 2019, the FDA warned that interim trial results found there was an increased risk of blood clots and death in patients prescribed the higher 10 mg twice daily dosage.

Patients should consult their doctor before they stop taking tofacitinib as prescribed, since it could worsen their illness.

Anyone who experiences an adverse side effect they believe was caused by the drug is urged to report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by completing a form online or by calling 1-800-332-1088 to have one mailed to them.

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