The Food and Drug Administration (FDA) has announced it is investigating potential safety concerns involving popular injectable diabetes and weight loss medications including Ozempic, Wegovy, Mounjaro, and Zepbound. Specifically, the agency is looking into post-marketing reports of hair loss and suicidal ideation.
Background on the Medications Under Investigation
Ozempic (semaglutide) and Wegovy (higher dose semaglutide) are glucagon-like peptide-1 (GLP-1) receptor agonists approved for treatment of type 2 diabetes and chronic weight management, respectively. Mounjaro (tirzepatide) is a dual GIP and GLP-1 receptor agonist also approved for type 2 diabetes and weight loss. Zepbound (lusdapatide) is a twice-weekly injection for type 2 diabetes.
These injectable medications mimic natural hormones that target receptors in the brain that regulate appetite and food intake. By activating these receptors, the drugs suppress appetite and promote feelings of fullness.
| Drug | Active Ingredient | Manufacturer | Approved Uses |
|---|---|---|---|
| Ozempic | semaglutide | Novo Nordisk | Type 2 diabetes |
| Wegovy | semaglutide | Novo Nordisk | Weight management |
| Mounjaro | tirzepatide | Eli Lilly | Type 2 diabetes, weight loss |
| Zepbound | lusdapatide | Eli Lilly | Type 2 diabetes |
Reports of Hair Loss and Suicidal Thoughts
In recent months, the FDA has received a number of adverse event reports related to hair loss and suicidal ideation with these medications.
The agency said it has received over 169 reports of people who experienced alopecia (hair loss) from Nov 2021 to Nov 2022 while being treated with the drugs. There were also 14 reports of suicidal thoughts or suicidal behavior with Ozempic from Jan 2018 to Nov 2022, and 109 reports involving Wegovy from June 2021 to Nov 2022.
Ongoing FDA Safety Review
Given the increasing use of these medications, the FDA said it considers the number of adverse event reports received so far to be low. However, it has prompted the agency to further investigate these potential signals.
“The FDA takes all reports of adverse events seriously,” said FDA spokesperson Lauren-Jei McCarthy. “We are continuing to monitor the safety profiles of semaglutide and other GLP-1 receptor agonists as part of our ongoing, routine safety monitoring.”
The agency said its adverse event reporting system collects information about possible side effects or other safety issues with FDA-regulated products. However the reports themselves do not mean the events were actually caused by the drug.
Additionally, the FDA stressed that suicidal ideation has been observed with many medications used to treat diabetes and weight loss, not just semaglutide formulations.
“We have not established a causal association between these diabetes and weight management medicines and suicidal ideation or alopecia,” McCarthy said.
What Consumers Should Know
Healthcare providers are advised to consider the benefits and risks when prescribing these medications to individual patients. People currently taking Ozempic, Wegovy, Mounjaro or Zepbound should not stop using their prescribed medications without first consulting their doctor.
Patients are also encouraged to contact their doctor right away if they experience any new, unusual or sudden changes in their mental health while undergoing treatment. Signs to watch for include anxiety, panic attacks, trouble sleeping, hostile behavior and impulsiveness. Hair loss or thinning hair should also be reported to one’s physician.
What Happens Next
The FDA review of post-marketing adverse events is ongoing. The agency said it will communicate findings and recommendations to the public as necessary.
Additionally, a large study published this week in JAMA Network Open found no evidence that semaglutide raises the risk of suicidal thoughts compared to other diabetes drugs. Researchers analyzed private insurance claims data on over 300,000 U.S. adults who began treatment with semaglutide or other medications. During an average of 10 months follow-up, patients using Ozempic/Wegovy actually had an 11% lower risk of suicidal ideation codes compared to those taking other treatments.
While positive, the FDA said longer-term safety data is needed. “We will continue to monitor and evaluate all data as they become available to us,” McCarthy noted.
The agency has called upon the drug manufacturers Novo Nordisk and Eli Lilly to conduct additional analyses on any potential suicidal ideation and alopecia risks. This could lead to revisions in the products’ labeling to better inform healthcare providers and patients. However there are currently no plans to restrict access or issue any recalls.
Going forward, the fate of these widely-used diabetes and obesity medications will depend on the what further investigation reveals about frequency and mechanisms of the reported adverse events. With more than 16 million prescriptions written in a year, the stakes remain high and all eyes are on the FDA review process. Patients and doctors alike anxiously await clarity around the safety profiles of Ozempic, Wegovy, Mounjaro and Zepbound.
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