FDA Investigating Reports of Alopecia and Suicidal Ideation as Possible Weight-Loss Drug Side Effects

The FDA is also investigating reported side effects of aspiration.

Boxes of the diabetes drug Ozempic rest on a pharmacy counter in Los Angeles, California, on April 17, 2023. Mario Tama/Getty Images

The U.S. Food and Drug Administration (FDA) is investigating whether three potential health issues or side effects, including suicidal ideation, hair loss, and aspiration, are linked to popular semaglutide and tirzepatide weight-loss drugs like Ozempic, Wegovy, and Mounjaro.

The investigation was unveiled on Tuesday with the agency’s quarterly report, which revealed that the FDA is looking into reports of the alleged side effects and if there is a need for regulatory action.

The FDA’s Adverse Events Reporting System (FAERS) Public Dashboard shows that since 2018, the agency has received 16,854 reports of adverse events from patients taking Ozempic. Of these, 108 were reports of suicidal ideation, nine were suicide attempts, and six were completed suicides. Fifteen reports of suicidal ideation were reported by Mounjaro users, and Wegovy users reported 14.

The FDA’s investigation is investigating 13 glucagon-like peptide-1 receptor agonist medications in all, which, like Ozempic, Mounjaro, and Wegovy, have been linked to potential suicidal ideation. In total, the FDA’s FAERS records show over 200 reports of suicide or suicidal ideation through September 2023 for semaglutides and tirzepatides.

The FDA’s newest actions align with other global medical communities. In July 2023, the European Medical Agencies began reviewing data on the risk of GLP-1 receptor agonists after receiving 150 reports of suicidal ideation and self-harm.

Only Wegovy, which has been approved for weight loss by the FDA, carries a warning for health care professionals to monitor patients for suicidal thoughts. Ozempic, approved to treat diabetes, does not carry a similar warning.

GLP-1 Medications Reported to Cause Alopecia, Aspiration

In addition to suicidal ideation, the FDA will also investigate whether the class of drugs used widely to manage diabetes and chronic weight issues leads to sudden hair loss and aspiration, or inhaling food or water into your windpipe instead of swallowing.

The FDA received close to 420 reports from patients through FAERS indicating they experienced alopecia after taking a semaglutide or tirzepatide GLP-1 agonist.

While there are fewer than 20 reports in FAERS of semaglutide or tirzepatide patients experiencing aspiration, one includes a patient whose doctors found food remains in the trachea and bronchi during surgery.

GLP-1 Agonists More Popular Than Ever

GLP-1 agonists have risen in popularity over the years due partly to their prevalence on social media and celebrity endorsements. In addition, they’ve been known to work for millions of people dealing with chronic weight management.

A September 2023 study noted the prescription weight-loss industry grew 72 percent more than expected in 2023, “ballooning to a $2.3 billion industry.” According to data from Epic Research, as reported by CNN, just over 5.6 million Americans were prescribed a type of semaglutide medication in 2023. CNN reported that prescriptions are up 40-fold from five years ago. The drugs’ popularity skyrocketed in 2022, with health care providers writing 9 million prescriptions for Ozempic and other semaglutides in the last quarter of 2022, according to a report from Trilliant Health.

However, researchers have warned the uptick comes with a cost.

“Many have voiced concerns about the availability and continuity of care interruptions inevitable for individuals with diabetes,” wrote the study authors of the September study. Other researchers and health care providers have expressed concerns regarding the drugs as a “quick-fix” solution without fully understanding the potential risks, especially as “Ozempic is intended for the treatment of type 2 diabetes but has been increasingly prescribed off-label without the benefit of an FDA-reviewed analysis of safety and efficacy data,” the researchers wrote.