Experts, FDA Concerned Xeljanz Heart and Cancer Problems May Affect Similar Arthritis Drugs

Amid growing evidence suggesting there are potential cancer and heart risks with Xeljanz, experts appear to be concerned the problems are not exclusive to the popular new-generation arthritis drug, but may be a class-wide side effects, which is leading to closer scrutiny of similar medications and delays in approving other drugs.

Xeljanz (tofacitinib) was the first introduced by Pfizer in 2012, as the first member of a new class of treatments, known as JAK inhibitors, which was approved for treatment of rheumatoid arthritis, psoriatic arthritis and ulcerative colitis.

The drug joined a lucrative market for rheumatoid arthritis drug, which already included blockbuster treatments like Humira, Enbrel and other similar medications, known as tumor necrosis factor (TNF) inhibitors. Xeljanz was marketed as a safer and more convenient treatment option, and quickly grew to become a top selling drug, with annual sales of more than $2 billion worldwide. However, data from a recently completed study raised questions about serious side effects of Xeljanz which are not disclosed on the drug’s warning label.

In February 2021, the FDA issued a safety communication about a potential link between Xeljanz and cancer, heart attacks and other cardiovascular heart risks, following a preliminary review of data from a recently completed post-marketing study. Since then, other JAK inhibitors have come under examination.

Last month, the FDA extended the review period of Incyte’s Jakafi, a bone marrow disease drug seeking expanded approval for steroid-refractory chronic graft-versus-host disease, due to concerns over potential heart and cancer risks.

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.

This month, media reports indicated Lilly and Incyte also announced the FDA has 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.

Xeljanz Heart and Cancer Lawsuits

The study behind the FDA 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.

Although the drug maker disclosed that lung cancer on Xeljanz was the most frequently reported malignancy identified in the study, no information has been provided about other types of cancer identified, or potential signs and symptoms for which former users should be monitored. In addition, it remains unclear how the Xeljanz cancer cases were distributed in time and across different doses of the medication, as well as how long users were monitored.

While awaiting access to the full data, rheumatologists and other experts have raised serious concerns about how the medication should be prescribed and question whether the FDA will be required to further restrict user of the medication, or even potentially recommend a Xeljanz recall. However, health experts caution that users should not stop taking the medication without first consulting with their own healthcare provider.

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.