File picture of a 0.25 mg injection pen of Novo Nordisk’s weight-loss drug Wegovy
| Photo Credit: Reuters
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.
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.
More than half of the narrative summaries describe suicidal thoughts appearing shortly after the person started the medicine or increased the dose. About two fifths of them said symptoms ceased after the patient stopped taking the drug or lowered the dose.
Thirty of the 113 narratives described patients with a history of depression, suicidal thinking or another mental-health condition. Another five reports explicitly said the patient had no history of psychological issues. Most reports don’t address that medical history.
Adverse-event reports provide a warning system for the medical community but aren’t considered definitive scientific evidence.
Submitted by doctors, patients, drugmakers and others, they often lack key details and do not on their own establish that a drug caused the potentially dangerous health events. Reuters identified the 265 reports by searching the government database for key words involving suicide and self-harm; it’s possible that additional reports of these side effects exist.
It’s also possible that the reports identified in these searches contain multiple submissions describing the same incident.
In a statement, Novo said it takes “all reports about adverse events from use of our medicines very seriously,” and that it would continue to monitor clinical data and collaborate with authorities. The company said it remains confident in the benefit-risk profile of the products and that its own safety monitoring has found no “causal association” between the drugs and thoughts of self-harm.
Cause for alarm
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.
Its 2021 approval kickstarted a new market for obesity drugs that is estimated to reach $100 billion within a decade.
Wegovy’s U.S. prescribing label, produced with FDA approval, says suicidal thoughts or attempts have been reported in clinical trials for other weight-loss medicines.
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