Here's What Experts Say about the Potential Link between Ozempic and Suicidal Thoughts

European regulators are currently conducting a review of data concerning suicidal thoughts in individuals taking GLP-1 receptor agonists (GLP-1 RA), such as Ozempic, Wegovy, and Saxenda. The review, which began earlier this month, includes approximately 150 reports of possible cases in which individuals on these medications experienced self-injury or thoughts of self-harm. A conclusion regarding the review is expected to be reached in November.

The investigation was initiated due to three cases of suicidal thoughts and self-harm reported to the Icelandic Medicines Agency.

The agency is examining the adverse effects and has mentioned that the presence of reports concerning self-harm or thoughts of self-harm does not necessarily imply that the medications caused such events.

In the United States, only Wegovy and Saxenda have been approved by the Food and Drug Administration (FDA) for weight loss. Ozempic is approved for the treatment of type 2 diabetes (as is Wegovy), but it is occasionally prescribed off-label as a weight loss medication.

Dr. Andrew Kraftson, the director of the Weight Navigation Program at Michigan Medicine, explained that if the agency establishes a link between the medications and self-harm or suicidal thinking, the risk is likely to be low.

He stated that these medications are not new, as the FDA first approved GLP-1 RA medications in 2005, and he has been prescribing them to patients for 18 years.

Dr. Kraftson also noted that the change in the patient population, from those with type 2 diabetes to those with diabetes or obesity, could lead to changes in side effects. However, he believes that these changes would likely be minimal in this case.

He emphasized that obesity is a complex disease with a high incidence of coexisting mental health disorders. Sometimes, the focus is primarily on treating weight rather than addressing the mental health issues related to obesity.

For individuals seeking help, Dr. Kraftson mentioned that Wegovy includes a standard warning regarding the potential increased risk of suicide, which is present in most, if not all, weight loss medications. However, the drug's clinical trials did not demonstrate this risk.

Dr. Jaime Almandoz, the medical director of the Weight Wellness Program at UT Southwestern Medical Center in Dallas, pointed out that adverse side effects can emerge once a drug is approved for use by the general public, despite being monitored during clinical trials.

He explained that clinical trial enrollment criteria are usually stringent and may not represent the entire population that will eventually use the medication. Considering the significant prevalence of obesity in the United States, it is likely that previously unseen physical or mental health side effects may arise as medications are utilized by a larger population.

When adverse events occur, regulatory agencies worldwide, including the FDA, track the incidents and initiate investigations like the ongoing one in Europe if a pattern emerges.

Dr. Kraftson highlighted the fact that the drugs being reviewed are not new and have been taken by a large number of individuals with diabetes for many years. He suggested that the absence of these adverse events in the diabetic population is noteworthy.

Although type 2 diabetes and obesity are distinct conditions, they frequently overlap. As much as 90% of people with type 2 diabetes are also overweight or obese.

Dr. Kraftson stated that while he does not want to discount the experiences of those reporting symptoms, risks and benefits must always be considered with any medication. He emphasized that the benefits of using these medications have been significant.

He recommended having comprehensive discussions with healthcare professionals and implementing appropriate safety monitoring plans. Both Dr. Almandoz and Dr. Kraftson agreed that mental health care should be a fundamental aspect of obesity treatment, regardless of whether a direct link is found between thoughts of self-harm and GLP-1 RA medications.

Dr. Almandoz suggested that individuals prescribed these medications should undergo mental health screening before starting the treatment. He emphasized the importance of treating people holistically rather than solely focusing on laboratory values or numbers on a scale.

Dr. Kraftson stated that the investigation has not affected his current prescribing practices. He explained that if a patient has unstable mental health issues, he typically advises against starting them on a weight loss regimen. Instead, he recommends that they address their mental health concerns first and seek approval from a mental health team before embarking on a weight loss program.

All providers that prescribe weight loss medications should do a complete and thorough history of a patient, including their mental health history, Almandoz added.

Comparing information about a person’s weight gain and loss patterns throughout their lives to their life circumstances may also reveal triggers that play a role in a person’s obesity.

“Life is very stressful and people with obesity may face a variety of challenges as their obesity increases, including not being treated fairly or kindly because of their weight, which adds to their stress,” said Almandoz, adding that sometimes, people with mental health conditions are prescribed medications that cause weight gain.

“Knowing your patient is key, as is making sure you have an open dialogue where if things change, patients have the opportunity to talk about it,” he said.

Almandoz also recommends that practitioners should be checking in on patients’ stress, sleep, and mood as they progress through weight loss journeys.

“It’s a more holistic way of treating obesity,” he said, “and we can monitor people who may be at risk for people who are at higher risk for suicide ideation.”