Despite Side Effects of Xeljanz and Rinvoq, FDA Still Approves New Indications After Updated Warnings

The approvals come after new warnings about Xeljanz and Rinvoq side effects, which have been linked to cancer, blood clots and heart problems.

Federal drug regulators are moving forward with the approval of more uses for a family of arthritis drugs, including Xeljanz and Rinvoq, despite concerns that side effects may increase the risk of cancer, blood clots and heart problems.

On December 14, Abbvie issued a press release announcing that the FDA has authorized new indications for use of the drug Rinvoq as a treatment for active psoriatic arthritis. On the same day, Pfizer issued a similar press release, announcing that Xeljanz has been approved for the treatment of active ankylosing spondylitis.

The new users for the rheumatoid arthritis drugs came just days after the approved new label warnings about side effects of Xeljanz and Rinvoq which indicate that users of the class of medications, known as Janus kinase (JAK) inhibitors, may be more likely to experience a heart attack, stroke, cancer, blood clots and death.

In a drug safety communication issued in September, the FDA announced a Xeljanz warning label update, after data from a large randomized clinical trial suggested that users were more likely to experience serious heart problems and cancer compared to older rheumatoid arthritis drugs. Since then, those concerns have spread to other JAK inhibitors as well, including Rinvoq and Olumiant.

As a result, JAK inhibitors are now increasingly considered a second-like treatment behind TNF blockers, such as Enbrel, Humira and Remicade.

Even with the new approvals for the two drugs, the FDA has recommended patients first be given a competing class of drugs, known as TNF blockers, should be the first line of treatment, and that JAK inhibitors should only be used if TNF blockers, such as Humira, could not be used or were not well tolerated by the patient.

The FDA first raised concerns about Xeljanz cancer and cardiovascular side effects in a drug safety communication in February 2021, after reviewing preliminary data from a postmarketing study, which sparked concerns that all JAK inhibitors may be affected.

As a result, in June, AbbVie announced expanded approval for Rinvoq was being held up due to similar problems. Before that, in April, Pfizer announced the review for its new oral JAK inhibitor, abrocitinib, had been extended by three months due to the same concerns.

In July, media reports indicated Lilly and Incyte also announced the FDA delayed approval of Olumiant; a rheumatoid arthritis drug seeking expanded approval as an Eczema treatment. It has already been approved to treat the skin condition in 40 countries.

The study behind the FDA’s Xeljanz concerns was initially launched in January 2012, and given the long latency period for many cancers, many users now face concerns they require on-going medical monitoring to detect and diagnose cases in the future.

Former users are now contacting lawyers who are investigating Xeljanz lawsuits and class action claims, to seek additional information which has not been disclosed and compensation for treatments they may now require.