The FDA is formally looking into reports that some people who took popular diabetes and weight loss drugs had suicidal thoughts or two other health problems.
A new FDA report listed potential links between the medications and a hair loss condition called alopecia, a swallowing problem that can occur during surgery called aspiration, or suicidal ideation, CBS News reported. The concern centers on reports of the health problems among people taking drugs known as GLP-1 receptor agonists, some of which are Ozempic, Wegovy, Mounjaro, and Zepbound. The drugs are used to treat diabetes and overweight or obesity.
An evaluation by the FDA doesn't mean that the FDA has concluded a risk exists, the FDA's webpage for risk evaluation cautions.
"It means that FDA has identified a potential safety issue, but it does not mean that FDA has identified a causal relationship between the drug and the listed risk," the FDA site states.
Possible next steps after the FDA looks into the reports could include updating drug labels with new information, putting a risk management plan in place to prevent or manage the health risks, or gathering more information.
"The FDA monitors the safety of drugs throughout their life cycle," even after the drugs are approved. In addition, the FDA uses "surveillance and risk assessment programs to identify and evaluate adverse events that did not appear during the drug development process," FDA spokesperson Chanapa Tantibanchachai said in an email published by multiple news outlets.
Although the review may lead to no changes in how a drug is regulated by the FDA, this isn't the first time that the popular medicines have landed on the FDA's radar for safety reevaluation. Last year, the label for the drug Ozempic was updated to acknowledge reports of intestinal obstructions, CBS News reported.
European regulators are also looking into reports of suicidal thoughts among people taking GLP-1 receptor agonists, although no link has been established.
Concerns about aspiration during surgery resulted in the American Society of Anesthesiologists advising in June that people should stop taking GLP-1 receptor agonists before they have elective surgeries.
"While there is currently a lack of scientific data on how GLP-1 receptor agonists affect patients having surgery and interact with anesthesia, we've received anecdotal reports that the delay in stomach emptying could be associated with an increased risk of regurgitation and aspiration of food into the airways and lungs during general anesthesia and deep sedation," the society's president, Michael W. Champeau, MD, said in a statement at the time.
According to CBS News, the FDA's drug reporting system links the medications to 201 reports of suicide or suicidal ideation, 18 reports that mention aspiration, and 422 reports that mention alopecia.
Drugmaker Novo Nordisk, whose portfolio includes Wegovy and Ozempic, told CNN that it works with the FDA to monitor safety and is aware of the reports of side effects.
"Novo Nordisk stands behind the safety and efficacy of all of our GLP-1RA medicines when they are used as indicated and when they are taken under the care of a licensed healthcare professional," the company said in a statement to CNN.
A spokesperson for Eli Lilly, which makes Mounjaro and Zepbound, told CBS News in a statement, "Currently, the FDA is reviewing data on certain potential risks for GLP-1 receptor agonist medicines. Patient safety is our priority, and we are collaborating with the FDA on these potential signals."
SOURCES:
CBS News: "Possible Ozempic side effects including hair loss and suicidal thoughts probed by FDA."
CNN: "FDA looking into reports of hair loss, suicidal thoughts in people using popular drugs for diabetes and weight loss."
European Medicines Agency: "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2023."
American Society of Anesthesiologists: "Patients taking popular medications for diabetes and weight loss should stop before elective surgery, ASA suggests."
Comments