Thursday, September 28, 2023
Dawn Heidlebaugh, who experienced distressing side effects while using Ozempic, a drug for diabetes and obesity, along with four others shared their struggles with Reuters, all reporting suicidal thoughts linked to drugs like Novo Nordisk's Ozempic and Wegovy, or Eli Lilly's Mounjaro.
These drugs, GLP-1 receptor agonists, slow digestion and reduce hunger.
Reuters found 265 cases of suicidal thoughts or behaviour related to these drugs in the US FDA's database since 2010, with 36 involving suicide. European regulators initiated an investigation in July.
Experts like Thomas J. Moore from the Johns Hopkins Bloomberg School of Public Health stress the importance of clear warnings when drugs carry rare but dangerous side effects. The FDA is evaluating these reports and considering actions.
This is the first extensive analysis of FDA reports on GLP-1 drug-related suicidal thoughts. More than half of the cases saw such thoughts shortly after starting or increasing the drug, but they often ceased when discontinuing or lowering the dose.
Novo Nordisk is taking these reports seriously, cooperating with authorities, and sees no causal link between the drugs and self-harm. Eli Lilly is working with regulators and reviewing relevant data.
Dr. Erick Turner, a former FDA medical officer, is concerned about patients without depression histories experiencing suicidal thoughts upon drug initiation, calling for regulatory attention.
The scrutiny comes as drugs like Wegovy gain popularity for their weight loss benefits. Ozempic, Wegovy, and Mounjaro showed no inherent suicide risk in FDA trials. However, healthcare professionals remain cautious.
Wegovy's US label mentions suicidal thoughts in trials for other weight-loss drugs and suggests monitoring at-risk patients. No such language appears on Ozempic's US label, approved for diabetes treatment in 2017. EU GLP-1 drug labels also lack such warnings.
The European Medicines Agency is investigating suicide risk for Ozempic, Wegovy, Saxenda, and other GLP-1 drugs. The UK and Canada are also reviewing these drugs. Manufacturers are cooperating with these inquiries.
The European regulator expects a conclusion in November. The FDA may act similarly if it finds increased suicide risk 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 detail for determination. The FDA's timeline for action is uncertain, as seen with past 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 might reach the brain, potentially explaining their appetite control but increasing neuropsychiatric side effect risks.
Patients experiencing suicidal thoughts need awareness and stronger warnings.