Ozempic ‘Fatal Outcomes’ Study Raises Serious Concern

Scientists have issued a warning over TikTok’s latest fat-melting “miracle” after it was linked to a series of rare but potentially fatal psychiatric episodes in a concerning new study.

Ozempic is an injectable prescription drug developed to manage blood sugar levels in patients with Type 2 diabetes. However, the diabetes drug has gained popularity due to one sought-after side effect: weight loss.

Ozempic is based on a naturally occurring human hormone called glucagon-like peptide 1 (GLP-1), which plays an important role in regulating appetite and blood sugar levels. Its active ingredient is a molecule called semaglutide, which mimics the structure of this GLP-1 hormone and activates its receptors.

By activating these receptors, semaglutide induces feelings of fullness while delaying the emptying of our stomach, making us less hungry and therefore less likely to overeat.

Semaglutide is also used in Ozempic’s sister drug, Wegovy, which has been approved by the FDA for chronic weight management. Between the start of 2020 and end of 2022, prescriptions of GLP-1 mimic medications like semaglutide increased by 300 percent across the U.S., according to healthcare analytics firm Trilliant Health.

The drug has since been endorsed by celebrities and influencers, with #ozempic reaching over 1.4 billion views on TikTok. However, when used as a weight loss drug, semaglutide has been shown to have some uncomfortable side effects.

Most studies into its side effects have focused on gut problems, but a new study, published in the International Journal of Clinical Pharmacy, has highlighted a concerning association between semaglutide and adverse psychiatric events, including depression, anxiety and suicidal thoughts. Pharmaceutical manufacturer Novo Nordisk, which produces Ozempic and Wegovy, cited the FDA saying that no evidence was found regarding suicidal thoughts or actions caused by these medicines.

“We believe that our findings, which highlight potential mental health issues associated with new anti-obesity medications, are of significant importance to both healthcare providers and patients,” the study’s first author, Mansour Tobaiqy, an associate professor in clinical pharmacology at the University of Jeddah in Saudi Arabia, told Newsweek. “These medications have become some of the most commonly used. The adverse events reported in this study serve as a reminder to physicians to carefully assess a patient’s mental health before prescribing these medications.”

To come to these results, Tobaiqy and co-author Hajer Elkout combed through the European Medicines Agency’s system for managing and reporting medication side effects, EudraVigilance. The pair analyzed case reports linked to semaglutide (Ozempic and Wegovy) as well as the related GLP-1 mimic drugs liraglutide (brand name Saxenda) and tirzepatide (brand name Mounjaro) between January 2021 and May 2023.

Over this period, 31,444 adverse events were reported, with 481 reports of adverse psychiatric episodes in total.

“According to the study’s findings, women made up 65 percent (n = 242) of the reports, while men accounted for 29 percent ( n=108),” Tobaiqy said. “Fatal outcomes were predominantly among men (eight out of nine), resulting from completed suicide attempts and depression. This is a serious matter that warrants attention.”

While more research is needed to confirm these results, Tobaiqy said that their findings warrant serious consideration by medical professionals when considering whether or not to prescribe these medications to their patients.

“Doctors should take into consideration any past suicidal thoughts or attempts by the patients,” he said. “Logically, if patients have these mental health issues, they should engage in a dialogue with their doctors to discuss alternative medications or interventions. Patients are also encouraged to report any changes in mood, behavior, or negative thoughts to their doctors…and health authorities.

“While I believe that the benefits of these medications, such as reducing the risk of cardiovascular disease, outweigh the risks, we must take the potential harm seriously, given the types and severity of the events reported.”

Michael Bloomfield, excellence fellow, head of the Translational Psychiatry Research Group and consultant psychiatrist at University College London, who was not involved in the study, echoed this sentiment.

“Given the potential severity of these side effects, I agree with the authors that further research into this is needed,” he told Newsweek. “It is difficult at this stage [to know] who may be particularly vulnerable nor how people can protect themselves without further research.

“In the meantime, people experiencing symptoms of depression including lowering of mood and suicidal thoughts during treatment with these drugs should consult their doctor. It may be that people with pre-existing depression or suicidal thoughts are more vulnerable to these potential side-effects, however that remains an open question.”

Bloomfield and Tobaiqy also emphasized that, while potentially significant, the rate of these psychiatric side-effects was very low. “It is [also] unclear whether these patients had pre-existing mental health conditions when they started using these medications,” Tobaiqy said. “[Therefore] we must exercise caution when interpreting these findings.”

Naveed Sattar, a professor of metabolic medicine at the University of Glasgow in Scotland, added that, without clear comparisons, it is difficult to confirm whether these psychiatric effects have anything to do with the medication or are simply a coincidence.

“There is no comparator of psychiatric risks in people with similar characteristics who had started on non-[GLP-1] therapy,” he told Newsweek. “Only by having some form of comparator does one get closer to the truth as psychiatric conditions are not uncommon in general. This does not mean further robust studies in this area are not needed. They are, but they should be high scientific quality and enable robust comparisons.”

Sattar also pointed to a recent, large-scale study from the Case Western Reserve University of Medicine in Ohio which did use such a comparison and found no higher risk of suicidal ideation after taking semaglutide-based drugs. “More similar studies would be helpful,” he said.

Newsweek spoke to pharmaceutical manufacturer Novo Nordisk, producer of Ozempic and Wegovy, to hear their thoughts on Tobaiqy and Elkout’s recent study. “Analyses of spontaneously-reported adverse event data (such as that performed by Tobaiqy and Elkout) are informative but suffer from numerous inherent limitations which preclude drawing conclusions about association or causation,” a spokesperson for Novo Nordisk told Newsweek in a statement. “Novo Nordisk is not aware of any reliable evidence linking semaglutide with suicidal ideation or behavior, or with other adverse psychiatric events.

“The FDA recently stated 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 receptor agonist medicines and the occurrence of suicidal thoughts or actions.

“Novo Nordisk is continuously performing surveillance of the data from ongoing clinical trials and real-world use of our products and collaborates closely with authorities to ensure patient safety and adequate information to healthcare professionals.

“Novo Nordisk stands behind the safety and efficacy of semaglutide and of all our other GLP-1 receptor agonist medicines when they are used as indicated and when they are taken under the care of a licensed healthcare professional.”

However, Tobaiqy also stressed that their findings draw on a wider issue surrounding the use of these drugs for “off label” applications. “I believe there is currently a worldwide misuse of these medications by individuals seeking to achieve slimness, even when they don’t necessarily need them,” Tobaiqy said. “Some counterfeit medications, available on the internet or black markets, may even lack active ingredients. Some are being sold without prescriptions, which poses a significant risk to patients’ health.

“My message is this: these medications are beneficial and efficient in treating type 2 diabetes and obesity. However, they should only be used under the supervision of medical professionals, whether they are endocrinologists or family doctors. All potential side effects, including mental health issues, must be closely monitored due to the novelty of these medicines.”