The US Federal Drug Administration (FDA) has issued a safety advisory statement for tofacitinib (Xeljanz) warning prescribers not to exceed the recommended dose in patients with rheumatoid arthritis.

The alert follows a postmarketing safety clinical trial of tofactinib in combination with methotrexate that found an increased risk of pulmonary embolism and death with a 10mg twice daily dose compared to the recommended 5mg twice daily dose of tofacitinib or a TNF inhibitor.

“[The] FDA 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,” the advisory statement says.

“Health care professionals should follow the recommendations in the tofacitinib 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.

On 19 February manufacturer Pfizer announced that the company had taken steps to transition rheumatoid arthritis study patients who were on tofacitinib 10 mg twice daily to tofacitinib 5 mg twice daily in the ongoing FDA post-marketing safety study.

“This action is being taken as the result of notification from the tofacitinib Rheumatology Data Safety Monitoring Board (DSMB) of a safety signal regarding the tofacitinib 10 mg twice daily treatment arm,” it said.

In Australia the recommended dose of tofacitinib in RA and Psoriatic Arthritis is 5mg twice daily.

A spokesperson for Pfizer Australia told the limbic: “We continue to evaluate the risk benefit profile of tofacitinib across all indications and will continue to work with regulators as more data become available, no further actions are being taken at this time.”