Wegovy, other weight-loss drugs, scrutinised over reports of suicidal thoughts

Dawn Heidlebaugh felt trapped in a disturbing pattern while taking Ozempic: lethargic, depressed and suicidal thoughts on Tuesdays, then repeating each week. 265 reports of suicidal thoughts/behavior linked to GLP-1 drugs since 2010, incl. 36 deaths by suicide/suspected suicide. FDA evaluating reports, assessing risk & deciding on action. Reports don't establish drug caused events, but warnings essential. Novo confident in drug's benefit-risk profile. Seek help if in distress.

Dawn Heidlebaugh felt trapped in a disturbing pattern while taking Ozempic, the popular drug used to treat diabetes and obesity.

Each Sunday for more than a year, the 53-year-old Ohio real estate agent took her weekly injection to help control her blood sugar. Then every Tuesday, she felt lethargic, depressed and sometimes suicidal, thinking her husband and four children might be better off without her. These feelings would last a few days, and the cycle repeated every week — except when she skipped a dose.

“I knew it was the drug,” said Ms. Heidlebaugh, who said she had not previously suffered from depression.

Ms. Heidlebaugh is one of four U.S. patients who told about experiencing suicidal thoughts while taking Novo Nordisk’s popular Ozempic drug, approved to treat type 2 diabetes, or Wegovy, another Novo top-seller approved for weight loss. A fifth patient said he experienced depression and suicidal thoughts after taking Mounjaro, a similar diabetes medicine from Eli Lilly, which is also used for weight loss. All three drugs are GLP-1 receptor agonists, which slow digestion and reduce hunger.

The U.S. Food and Drug Administration has received 265 reports of suicidal thoughts or behavior in patients taking these or similar medicines since 2010, Reuters found in an examination of the agency’s adverse-event database. Thirty-six of these reports describe a death by suicide or suspected suicide. The FDA monitors such reports to help decide whether to further investigate a drug’s safety and take action to protect patients, such as mandating a warning label.

Accounts of suicidal thoughts linked to this class of drugs are drawing increasing scrutiny, including an investigation by European regulators announced in July. In a statement, the FDA said it is evaluating such reports and will decide on what action, if any, to take after a thorough review.

Many beneficial drugs have rare and sometimes dangerous side effects that have to be carefully assessed by regulators and managed by physicians, making clear warnings essential in such cases, said Thomas J. Moore, faculty associate at the Johns Hopkins Bloomberg School of Public Health.