FDA approves labeling changes for fenofibrates due to lack of cardiovascular benefits
The U.S. Food and Drug Administration (FDA) has updated the labeling requirements for fenofibrates to highlight the fact that these medications are not associated with any specific cardiovascular benefits. Fenofibrates are primarily prescribed to lower a patient’s cholesterol. There was once a belief that they could protect against heart disease as well, but clinical trials have not supported that idea.
This labeling update comes after the FDA received a petition from HealthyWomen, a patient advocacy group focused on educating middle-aged women about their health, in 2024. The group asked that the labeling for these medications be revised in several ways to really emphasize that there is no proven cardiovascular benefit to treatment. One of its primary pieces of evidence was the PROMINENT clinical trial, which found that treatment with pemafibrate was not associated with significant cardiovascular risk reductions.[1]
After a lengthy review, the FDA ultimately agreed to the labeling revisions, noting that it had already been considering such revisions.
“I am so glad to see this positive response to the citizen petition by the FDA,” cardiologist Payal Kohli, MD, founder and medical director of Cherry Creek Heart in Aurora, Colorado, told Cardiovascular Business. “The FDA has acknowledged that the group most likely to benefit, as represented in the PROMINENT trial, didn’t show any benefit, which really reinforces to the practicing clinician that no fibrate should be used for cardiovascular risk reduction.”
The labeling update also highlights the risks patients may face when prescribed these medications. For example, the PROMINENT data found that pemafibrate was linked to an increased risk of venous thromboembolism compared to a placebo. The new labeling specifically calls out that risk for healthcare providers and patients alike.
“Not only do fibrates lack cardiovascular risk reduction data … they may also impose risk,” Kohli said. “They shouldn’t be used without serious thought.”
FDA denies request for additional communication
The petition also requested the FDA send out special communications to healthcare providers and patients about these labeling changes. The agency denied this request, however, saying it has already “taken multiple actions” to inform the public about this topic. According to Kohli, this makes it especially important to spread the word about this change.
“Since the letters aren’t being sent out by the FDA, these changes deserve to be in the spotlight so that they can get to the doctors and providers at the bedside to implement many of these changes,” she said.
The FDA’s full response to HealthyWomen can be read here. The original petition is available here.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.