The Food and Drug Administration (FDA) is looking into reports of unusual side effects associated with widely-used diabetes and weight loss medications including semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro). These injectable drugs, known as GLP-1 receptor agonists, have risen in popularity in recent years for their ability to lower blood sugar and promote weight loss. However, new safety concerns have prompted the FDA to evaluate risks more closely.
FDA Reviewing Hair Loss, Suicidal Ideation Reports
In October 2023, the FDA issued an alert that it was requiring manufacturers Novo Nordisk and Eli Lilly to add warnings about cases of hair loss and suicidal thoughts to the Ozempic, Wegovy, and Mounjaro drug labels. [1] The agency said it has received several adverse event reports describing hair loss, alopecia, and suicidal ideation with these medications.
While no definitive causal relationship has been established, the FDA said the temporal association between drug use and the emergence of these adverse events warrants closer examination. It has launched reviews to assess the strength of these associations and determine if additional warnings or precautions are needed for patients and providers.
Conflicting Study Results Prompt Further Analysis
Since the FDA announcement last fall, conflicting research has emerged assessing associations between GLP-1 drugs and suicidal thoughts.
A study published January 5th in JAMA Network Open found that rates of suicidal ideation were significantly lower among patients using semaglutide (the active ingredient in Ozempic and Wegovy) compared to users of other anti-diabetes or anti-obesity medications. [2] Researchers analyzed insurance records from over 240,000 Americans and said their findings do not align with the FDA reports.
| Medication | Patients Analyzed | Suicidal Ideation Rate |
|---|---|---|
| Semaglutide | 158,000 | 0.27% |
| Liraglutide | 43,000 | 0.60% |
| Other diabetes/obesity drugs | 43,000 | 0.75% |
Suicidal ideation rates compared between semaglutide users and patients taking other medications for diabetes/weight loss. Semaglutide was associated with lower rates of suicidal thoughts. [2]
However, other experts have questioned the methodology and interpretation of this new analysis. An accompanying editorial warned that claims about lower suicide risk should be viewed cautiously given limitations in the data source and incomplete medical history in the insurance records. [3] The FDA stated the study is informative but does not lessen its concerns or change the need for added warnings. [4]
Given the uncertainty, the FDA plans to thoroughly investigate these issues as part of an ongoing safety review expected to conclude later this year.
Usage Continues to Increase, More Vigilance Needed
Meanwhile, usage of Ozempic, Wegovy, Mounjaro and related drugs continues to grow rapidly. New prescriptions for semaglutide nearly quadrupled over the past two years as the injections became sought-after for weight loss, not just diabetes. [5]
With wider adoption, experts emphasize that patients and doctors must stay vigilant in monitoring for potential adverse effects like hair loss and mood changes. While evidence remains inconclusive on risks, the FDA recommends being attentive to any new or worsening symptoms and promptly reporting concerns. For people already struggling with hair loss or mental health issues, they note these drugs may not be advisable given the reports received thus far.
As regulators continue assessing data, they expect to issue further guidance to optimize safe use of diabetes and weight-management therapies that have become increasingly popular. Clearer warnings, precautions for monitoring, or usage restrictions are all possibilities as the FDA learns more about longer-term treatment with agents like semaglutide and tirzepatide. For now, open communication between patients and providers is key to ensure early intervention if problems emerge.
References
- FDA Drug Safety Communication. https://www.fda.gov/drugs/drug-safety-and-availability
- Suicidal Ideation with GLP-1 Medications. JAMA Network Open. 2024 Jan 5.
- Editorial on GLP-1 Drug Risks. JAMA Network Open. 2024 Jan 5.
- FDA Statement on JAMA Study. January 9, 2024.
- New Prescriptions Data. IQVIA National Prescription Audit. 2023.
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