FDA links weight loss pill to ‘unexpected’ cardiovascular risks
Orforglipron, Eli Lilly and Company’s new GLP-1 receptor agonist pill being sold under the brand name Foundayo, made headlines in early April when it received U.S. Food and Drug Administration (FDA) approval for treating weight-related medical problems in obese adults. It was the second GLP-1 pill to secure FDA approval, following Nova Nordisk’s oral semaglutide/Wegovy.
Now, it turns out that the FDA has unanswered questions about the pill’s potential cardiovascular side effects. According to the agency’s approval letter, early clinical research on orforglipron was associated with an “unexpected serious risk for major adverse cardiovascular events” as well as increased risks of retained gastric contents, drug-induced liver injury and exposure to orforglipron during lactation.
It is not necessarily unusual for the FDA to seek additional information after initially approving a drug or medical device. Considering the widespread use of GLP-1 drugs, however, this is a topic cardiologists and primary care physicians alike will want to watch closely in the months ahead.
FDA wants more data on orforglipron
As a result of these concerns, the FDA has urged Lilly to complete its ongoing ACHIEVE-4 study and share data on the potential cardiovascular impact of taking once-daily orforglipron. The agency wants data on specific outcomes, including cardiovascular death, nonfatal myocardial infarction, hospitalization for unstable angina and nonfatal stroke. A final report is expected by July.
The FDA also told Lilly to conduct a series of other clinical trials, with the latest expected to be completed in June 2029.
Lily, meanwhile, has confirmed it will be monitoring these risks.
“Patient safety is Lilly’s top priority and we actively monitor, evaluate, and report safety information for all our medicines,” a company spokesperson told NBC News.
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.