Wegovy, other weight-loss drugs scrutinized over reports of suicidal thoughts
- Dawn Heidlebaugh felt trapped in a disturbing pattern while taking Ozempic, the popular drug used to treat diabetes and obesity.
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.
The Reuters review is the first exhaustive examination of FDA adverse-event reports involving incidents of suicidal thinking linked to GLP-1 drugs. The news organization also filed public records requests to obtain 113 more-detailed narratives for individual incidents among the 265 reports in the FDA database. The experiences of the five patients who spoke with Reuters have not been previously reported.
It’s also possible that the reports identified in these searches contain multiple submissions describing the same incident. “That makes it harder to explain away the suicidality,” said Turner, a professor of psychiatry at Oregon Health & Science University. “It makes any occurrence of those safety signals more credible.”Millions of patients are being encouraged to try drugs such as Wegovy, which led to an average loss of 15% of a person’s body weight in clinical trials, making it the most effective approved weight-loss treatment to date.
Novo’s Saxenda, a GLP-1 approved in 2014 for weight loss and included in the Reuters analysis of adverse event reports submitted to the FDA, contains an FDA warning because suicidal thoughts or behaviors were seen in some patients during the company’s clinical trials. If the FDA finds that GLP-1 drugs increase suicide risk, it could also require warnings. In the case of Wegovy, the agency could strengthen the existing warning by requiring more explicit language linking the drug to suicide risk. The agency’s strongest action, short of banning a drug, is to issue a so-called black-box warning, which could prompt some doctors and patients to avoid the medicine.
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