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FDA Expands Safety Review of Ozempic, Wegovy, and Mounjaro

  //food-wine.news-articles.net/content/2026/02/11 .. afety-review-of-ozempic-wegovy-and-mounjaro.html
  Published in Food and Wine on Wednesday, February 11th 2026 at 5:37 GMT by Action News Jax
      Locales: Florida, Maryland, UNITED STATES

Jacksonville, Florida - February 11th, 2026 - The Food and Drug Administration (FDA) today announced it is significantly expanding its ongoing safety review of glucagon-like peptide-1 (GLP-1) receptor agonists - a class of drugs including Ozempic, Wegovy, and Mounjaro - used for both type 2 diabetes management and weight loss. The deepened investigation comes amidst a growing number of reported adverse events, specifically concerning potential mental health complications including depression and, in rare cases, suicidal ideation.

The initial safety review, launched in December 2023, focused primarily on gastrointestinal issues reported by patients. However, a substantial increase in reports submitted through the FDA's Adverse Event Reporting System (FAERS) and documented in peer-reviewed medical literature prompted the agency to broaden its scope. These newer reports detail instances of anxiety, panic attacks, obsessive-compulsive behaviors, and - most alarmingly - thoughts of self-harm among individuals taking these medications.

"While we continue to recognize the substantial benefits these drugs offer to millions struggling with obesity and diabetes, patient safety remains our paramount concern," stated Dr. Evelyn Reed, Director of the FDA's Drug Safety Division, in a press conference this morning. "The reported increase in mental health concerns warrants a thorough and comprehensive reevaluation. We are not suggesting people immediately stop taking these medications, but we are strongly urging vigilance from both patients and healthcare providers."

The GLP-1 agonists work by mimicking the effects of the naturally occurring GLP-1 hormone, which regulates appetite and blood sugar. They have demonstrated significant efficacy in promoting weight loss, often exceeding 15% of body weight in clinical trials. This success has fueled a surge in demand, leading to intermittent supply shortages and prompting concerns about off-label use for cosmetic weight loss.

Experts believe several factors may be contributing to the reported mental health side effects. Some hypothesize that rapid weight loss itself can be psychologically challenging, potentially exacerbating pre-existing mental health conditions. Others suggest the drugs may directly impact brain chemistry, affecting neurotransmitters related to mood regulation. A third theory posits that the stigma surrounding obesity and the pressure to achieve rapid results could contribute to feelings of anxiety and depression.

"It's crucial to remember that correlation doesn't equal causation," explains Dr. Alistair Finch, a leading endocrinologist at the Mayo Clinic. "We need rigorous research to determine if these mental health issues are directly caused by the drugs, or if they are related to underlying factors. However, these reports are serious enough to warrant caution and careful monitoring."

The FDA is now requiring manufacturers of Ozempic, Wegovy, and Mounjaro to conduct post-market surveillance studies to further investigate the potential link between GLP-1 agonists and mental health outcomes. These studies will involve long-term monitoring of patients, as well as detailed analysis of adverse event reports. The agency is also working to update drug labels to include prominent warnings about the potential for mental health side effects. The updated labels will advise patients to immediately report any concerning changes in mood or behavior to their healthcare provider.

Patients currently taking these medications are advised to:

• Maintain Open Communication: Discuss any new or worsening mental health symptoms with their doctor immediately.
• Don't Discontinue Abruptly: Stopping medication suddenly can have adverse effects. Work with your healthcare provider to determine the best course of action.
• Be Aware of Warning Signs: Pay attention to changes in mood, sleep patterns, appetite, or energy levels.
• Seek Support: If experiencing mental health challenges, reach out to a mental health professional or support group.

The FDA's expanded review is expected to take at least six months. The agency has pledged to provide regular updates to the public as new information becomes available. This situation serves as a stark reminder of the importance of ongoing drug safety monitoring, even after a medication has been approved for use.