FDA evaluating miracle weight-loss drugs like Ozempic for suicide risk

By Brendan Keefe

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    ATLANTA, Georgia (WANF) — Clint Etheridge woke up after two days in the hospital. He had not expected to survive.

“I have zero doubt that this drug caused me to be suicidal and I almost lost my life from it,” Etheridge said, referring to semaglutide, the active ingredient in the blockbuster diabetes and weight-loss drugs Ozempic and Wegovy.

The drugs are so popular the exclusive patent holder, Novo Nordisk, has been ramping up production to meet extraordinary demand. Because of those shortages, Etheridge was not able to get the drug made by Novo Nordisk. Instead, his doctor prescribed semaglutide from a local compounding pharmacy.

“I know without a doubt that it made me violently depressed,” Etheridge said. “I wanted to remain on it, and thought I might stay on it for life, but it just got progressively worse and it led to a suicide attempt.”

Etheridge filed a report on the Food and Drug Administration’s Adverse Event Reporting System (FAERS), which is a self-reporting system. The claims made there are not confirmed by the FDA.

Atlanta News First Investigates reviewed FAERS reports for people taking Ozempic, Wegovy or compounded semaglutide. There were 262 self-reported cases mentioning suicide attempts, ideation, threats, behavior, treatment; or depression.

There were 20 reported suicides in the FAERS data.

Reports of suicidal ideation and depression are still extremely rare compared with other side effects, based on a review of 25,097 self-reported adverse events for semaglutide and brand-name equivalents.

Etheridge said he knows what those fellow patients experienced. “They feel strangely like kindred spirits who went through the same thing that I did [who] just didn’t make it,” he said.

The FDA “has been evaluating reports of suicidal thoughts or actions in patients treated” with this class of drugs, according to a drug safety communication released by the agency in January.

“Our preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions,” the FDA said, citing both large-outcome studies and the limited information in the FAERS reports.

The agency is still investigating because “we cannot definitively rule out that a small risk may exist; therefore, FDA is continuing to look into this issue,” the agency said, adding it would communicate its final conclusions once the review is complete.

Ozempic and Wegovy both use the active ingredient semaglutide delivered as once-weekly injections. Ozempic is approved for diabetes treatment, while Wegovy is approved for obesity and weight-loss treatment.

Both versions of the drug result in weight loss.

Until this month, the two products came with similar 15-page prescribing information sheets. Wegovy prescribers were told to “monitor for depression or suicidal thoughts” and “discontinue if symptoms develop.”

The sheet for Wegovy instructed medical professionals to “advise patients to report emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.”

The word “depression” appeared four times, while “suicidal” appeared 14 times in the Wegovy information. Those words do not appear in the documentation for Ozempic.

The Wegovy prescribing information sheet posted online was just updated this month. It is now 43 pages. References to depression and suicidal thoughts have not substantially changed.

Novo Nordisk told Atlanta News First Investigates, “Although Wegovy and Ozempic® both contain semaglutide, they are different products with different indications, dosages, prescribing information, titration schedules, and delivery forms. The products are not interchangeable and should not be used outside of their approved indications.”

One study analyzed Europe’s adverse event reporting system and found a correlation between patients taking this class of weight-loss drugs and psychiatric events. The study, published in the International Journal of Clinical Pharmacy, found they represented only 1.2 percent of all adverse events.

“However, the severity and fatal outcomes of some of these reports warrant further investigation,” the study said.

European regulators began inquiries to examine any potential link last summer. The FDA soon followed.

The most recent study, published in January by the journal Nature Medicine, found a much lower risk of depression and suicide compared with other weight-loss drugs.

The Nature Medicine study was conducted in cooperation with the National Institutes of Health. “Our findings do not support higher risks of suicidal ideation with semaglutide compared with non-GLP1R agonist anti-obesity or anti-diabetes medications,” the authors concluded.

Novo Nordisk response Atlanta News First Investigates reached out directly to the patent holder for semaglutide, Novo Nordisk.

The company confirmed people with suicidal or psychiatric histories were excluded from trials of Wegovy but not for Ozempic. Both drugs received full FDA approval as safe and effective.

Novo Nordisk issued a full statement for this article:

“Patient safety is the top priority for Novo Nordisk and we will continue to collaborate closely with the U.S. Food and Drug Administration (”FDA”) to continuously monitor the safety of all of our GLP-1RA medicines. We are aware that, as part of those monitoring efforts, FDA is evaluating several potential signals related to GLP-1RA medicines, including suicidal thoughts or actions, and has posted information about those ongoing assessments on its website. In this instance, the FDA states that their “preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions.” Similarly, our reviews of the clinical trials, including large outcome studies and observational studies, did not find an association between use of GLP-1 RA medicines and the occurrence of suicidal thoughts or actions. We look forward to working with FDA as they complete their review. The known risks associated with use of those medicines are reflected in their current FDA-approved product labeling. Novo Nordisk stands behind the safety and efficacy of all of our GLP-1RA medicines when they are used as indicated and when they are taken under the care of a licensed healthcare professional.”

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