Rinvoq Warning Label Updated to Add Cancer and Heart Risks Seen With Xeljanz Side Effects

The makers of Rinvoq have announced that new label warnings will be added to indicate users may face the same risk of cancer and heart problems, which were recently associated with side effects of Xeljanz, a similar medication that is part of the same class.

In a press release issued on December 3, AbbVie indicated it was updating the U.S. Prescribing Information and Medication Guide for Rinvoq, a rheumatoid arthritis drug that is part of a new-generation of treatments, known as Janus kinase (JAK) inhibitors.

The Rinvoq warnings reflect recent data about the risk of heart attacks, strokes, cancer, blood clots and death, which were identified in post-marketing studies recently conducted for Xeljanz; a competing drug that was the first JAK inhibitor introduced in the U.S.

In a drug safety communication issued in September, the U.S. Food and Drug Association (FDA) announced that 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 now increasingly considered a second-like treatment behind TNF blockers, such as Enbrel, Humira and Remicade.

“Based on this class-wide update, the U.S. label for RINVOQ will now include additional information about the risks of malignancy and thrombosis, and the addition of mortality and MACE (defined as cardiovascular death, myocardial infarction and stroke) risks within the Boxed Warnings and Warnings and Precautions sections,” the AbbVie press release states. “The indication has also been updated to the following: RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers.”

The FDA first raised concerns about additional Xeljanz cancer and cardiovascular side effects in a drug safety communication in February based on 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.