EMA Calls for Restricted Use of Xeljanz, Rinvoq, Similar Drugs Due to Heart, Cancer, Blood Clot and Infection Risks

Regulators made the determination following recent studies linking Xeljanz side effects to adverse health risks.

European drug regulators are calling for restrictions on the use of Xeljanz, Rinvoq and similar arthritis drugs, due to the risk of heart problems, blood clots, cancer and serious infections.

In a news release issued on October 28, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) issued recommendations and warnings about the side effects of Xeljanz and other medications that are part of a new class of drugs, known as JAK inhibitors.

Xeljanz Linked to Risk of Cancer, Heart Problems, Blood Clots, Other Side Effects

Xeljanz (tofacitinib) was introduced by Pfizer in 2012, as the first member of this new class of medications, joining a lucrative market for treatment of rheumatoid arthritis, psoriatic arthritis and ulcerative colitis, which already included some of the top selling medications on the market in the U.S. The new class also includes Rinvoq, Olumiant and other drugs that have been introduced in recent years

Following data from a post-marketing clinical trials, which identified several potentially serious side effects of Xeljanz, the FDA required new label warnings about heart and cancer risks for the entire class of medications late last year.

As a result, the drug maker now faces a growing number of Xeljanz lawsuits brought by former users diagnosed with a variety of injuries, including cancers, heart attack, stroke, pulmonary embolism, deep vein thrombosis (DVT) and other complications.

PRAC’s recommendations call for Xeljanz, Rinvoq and other JAK inhibitors to only be used by certain patients, if no suitable alternative treatments are available. These patients include those 65 or older, patients with an increased risk of heart problems, such as heart attack or stroke, those who smoke or have done so for a long time in the past, and those facing an increased risk of cancer.

“The Committee also recommended using JAK inhibitors with caution in patients with risk factors for blood clots in the lungs and in deep veins (venous thromboembolism, VTE) other than those listed above,” the press release states. “Further, the doses should be reduced in some patient groups who may be at risk of VTE, cancer or major cardiovascular problems.”

The committee came to its conclusions after reviewing the final results from a study published in January in the New England Journal of Medicine, which found an increased risk of major heart problems and cancer linked to Xeljanz use. They also relied on the preliminary findings of an observational study involving Olumiant.

The PRAC determined that a review of the study data confirmed Xeljanz increases the risk of major cardiovascular problems, cancer, VTE, serious infections and death, when compared to a competing class of arthritis medications known as TNF-alpha inhibitors, like Humira.

The committee also determined these risks cut across all approved uses of JAK inhibitors, such as arthritis, ulcerative colitis, atopic dermatitis and alopecia areata.

November 2022 Xeljanz Lawsuit Update

Several dozen Xeljanz lawsuits are currently being pursued by former users diagnosed with cancer, heart attacks, strokes, pulmonary embolism, deep vein thrombosis and other cardiovascular injuries.

Although each of the complaints raise similar questions of fact and law, there are not currently any consolidated pretrial proceedings in the federal court system, and each of the lawsuits is moving forward on an individual tract. However, as Xeljanz lawyers continue to investigate and file new claims, the size and scope of the litigation is expected to increase throughout 2022 and 2023.