The FDA has added boxed warnings on the labels of Pfizer’s Xeljanz, Eli Lilly’s Olumiant, and AbbVie’s Rinvoq, JAK inhibitors used to treat conditions such as rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, Reuters reports. The serious warnings flag risks of cardiovascular death and stroke in high-risk patients who are aged 50 and above and are current or past smokers.
The added warning follows the agency’s review of results from a February trial of Xeljanz, which showed increased risks of serious heart problems and cancer in some patients.
