Healio Instagram Resource Center

Healio Instagram Resource Center

September 01, 2021
2 min read
Save

FDA adds black box warning to JAK inhibitors; cites heart-related issues, cancer, death

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

The FDA has called for additional warning labels on janus kinase inhibitors after a safety review found this class of medications was associated with an excess risk for serious heart-related events, cancer, blood clots and death.

An alert was previously issued by the FDA in February about the risk for serious health-related problems and cancer linked to tofacitinib (Xeljanz, Pfizer) compared with TNF inhibitors among older patients. However, given new safety data, the FDA has also issued new and updated warnings for two additional JAK inhibitors: baricitinib (Olumiant, Eli Lilly & Co.) and upadacitinib (Rinvoq, AbbVie).

The FDA has called for additional warning labels on janus kinase inhibitors after a safety review found this class of medications was associated with an excess risk for serious heart-related events, cancer, blood clots and death. Source: Adobe Stock

“We are requiring revisions to the Boxed Warning, FDA’s most prominent warning, for Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to include information about the risks of serious heart-related events, cancer, blood clots and death,” the FDA said in a statement.

“Other JAK inhibitors have not been studied in similar large safety clinical trials, so the risk with these medicines has not been evaluated. However, since they share mechanisms of action with Xeljanz, FDA considers that these medicines may have similar risks as seen in the safety trial with Xeljanz.”

The FDA based its warning on results from ORAL Surveillance, a post-marketing safety clinical trial required by the FDA to demonstrate non-inferiority of Xeljanz compared to TNF inhibitors among patients with rheumatoid arthritis with regard to risk for cardiovascular events and malignancies. This trial also investigated other potential risks, including blood clots in the lungs and death.

“Our review of the final trial results showed a higher rate of serious heart-related events such as heart attack and stroke, cancer, blood clots, and death in patients treated with both doses of Xeljanz compared to those treated with TNF blockers,” the FDA noted. “Importantly, a higher rate of blood clots and death was seen with both doses of Xeljanz compared to TNF blockers, whereas previous interim results showed the risk only with the higher dose. For cancers, a higher rate of lymphomas was observed in patients treated with Xeljanz compared to those treated with TNF blockers. A higher rate of lung cancers was observed in current or past smokers treated with Xeljanz compared to those treated with TNF blockers.”

The new and updated warning labels on all JAK inhibitors will address the increased risk of major adverse cardiovascular events, malignancy, thrombosis and mortality. Additionally, the FDA recommends that health care professionals consider the benefits and risks for individual patients before initiating or continuing treatment with JAK inhibitors, particularly among patients who are current or past smokers, those with other cardiovascular risk factors, those who develop a malignancy and those with a known malignancy other than a successfully treated nonmelanoma skin cancer.