The post-marketing Xeljanz drug safety study showed an increased risk of serious heart problems and stroke in a subgroup of patients treated with Xeljanz. The FDA issued a safety alert on the drug on February 4, 2021. The results of the study showed that the drug had a high risk of thrombosis. In response, Pfizer revised its label to warn of an increased risk of thrombosis.
This Unethical Behavior Exposed Thousands Of Consumers
After the Xeljanz drug safety study, the FDA ordered another one. In the first one, the FDA had approved the drug for use in the treatment of psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, and juvenile idiopathic arthritis. In the post-marketing Xeljanz safety study, it was found that the adverse effects were even worse than originally believed. The drug’s makers were aware of the side effects but failed to disclose them in order to protect their profits. This unethical behavior exposed thousands of consumers to an increased risk of harm.
A post-marketing Xeljanz drug safety study is necessary to assess the drug’s effects on heart attacks and cancer. Despite the Xeljanz drug’s success, the FDA has cited several safety warnings for JAK inhibitors. These include the increase risk of thrombosis and cardiovascular disease. Further, the FDA has slapped a “black box” warning on the drug.
