Xarelto and the FDA: An Uneasy Relationship
Since the U.S. Food and Drug Administration (FDA) first approved Xarelto for use in 2011 after hip or knee surgeries, the drug has been placed under intense scrutiny by the agency. Even though the FDA granted approval for the medication to prevent pulmonary embolism (blood clots in the lung) and deep vein thrombosis after hip and knee procedures, the agency had serious concerns about the protocols used in conducting certain clinical studies. Over the years, the FDA has had some reservations regarding Xarelto. Here are a few examples.
The FDA required new language be added to Xarelto labeling in regard to warnings and precautions. This new verbiage notified doctors, caregivers and patients about possibly dangerous side effects and risks associated with the drug. For example, a warning was added informing patients of the risks of using Xarelto after receiving epidural anesthesia for a spinal procedure. There was also a warning added about the lack of an antidote should excessive bleeding occur in a patient taking the drug.
The agency sent a letter to Johnson & Johnson (the parent company of Xarelto manufacturer Janssen Pharmaceuticals) informing the company that its advertising was misleading. According to the agency, the ads, which occurred in WebMD magazine, downplayed the potential risks of taking the drug. It also found that the ad mistakenly claimed that Xarelto needed no dosage adjustments.
The FDA’s Cardiovascular and Renal Drugs Advisory Committee met to discuss whether the uses of Xarelto should be extended. The committee could not agree on whether to grant the new uses or to wait for further information; some of the members said the evidence presented by Johnson & Johnson was unreliable. It eventually voted 6-4 against allowing these uses. However, the FDA ultimately allowed some expansion in November of that year.