Dawn Heidlebaugh, who experienced painful side effects while using Ozempic, a diabetes and obesity drug, along with four others shared their struggles with Reutersall reports of suicidal thoughts linked to drugs such as Novo Nordisk’s Ozempic and Wegovy or Eli Lilly’s Mounjaro.
These drugs, GLP-1 receptor agonists, slow down digestion and reduce hunger.
Reuters found 265 cases of suicidal thoughts or behavior related to these drugs in the US FDA database since 2010, with 36 involving suicide. European regulators launched an investigation in July.
Experts like Thomas J. Moore of the Johns Hopkins Bloomberg School of Public Health stress the importance of clear warnings when drugs have rare but dangerous side effects. The FDA is evaluating these reports and considering actions.
This is the first comprehensive analysis of FDA reports of suicidal thoughts associated with the drug GLP-1. More than half experienced such thoughts shortly after starting or increasing the drug, but they often stopped when the dose was stopped or reduced.
Novo Nordisk takes these reports seriously, is cooperating with the authorities and sees no causal link between drugs and self-harm. Eli Lilly is cooperating with regulatory authorities and reviewing relevant data.
Dr. Eric Turner, a former FDA physician, is concerned about patients without a history of depression who experience suicidal thoughts when starting the drug, calling for regulatory attention.
The review comes as drugs like Wegovy gain popularity for their weight loss benefits. Ozempic, Wegovy, and Mounjaro showed no inherent risk of suicide in FDA trials. However, health professionals remain cautious.
Wegovy’s US label reports suicidal thoughts in trials of other weight-loss drugs and suggests monitoring patients at risk. No such language appears on the US label for Ozempic, which was approved for diabetes treatment in 2017. EU GLP-1 drug labels also lack such warnings.
The European Medicines Agency is investigating the risk of suicide for Ozempic, Wegovy, Saxenda and other GLP-1 drugs. The UK and Canada are also looking at these drugs. Manufacturers are cooperating with these investigations.
The European regulator expects a conclusion in November. The FDA may act similarly if it finds an increased risk of suicide with GLP-1 drugs, potentially mandating warnings or stronger language linking the drugs to suicide risk.
Novo Nordisk submitted 180 of the 265 reports, but most had insufficient details for identification. The FDA’s timeline for action is uncertain, as seen with older drugs like Singulair, which took 12 years to receive a black box warning for suicidal thoughts.
Weight loss drugs have faced similar concerns. Sanofi’s Acomplia was withdrawn in Europe in 2008 due to suicidal thoughts. Contrave carries a black box warning and Qsymia advises discontinuation if suicidal thoughts occur.
GLP-1 drugs can reach the brain, possibly explaining their appetite control, but increasing the risks of neuropsychiatric side effects.
Patients experiencing suicidal thoughts need awareness and stronger warnings.
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