According to the U.S. Food and Drug Administration, drugs like Wegovy and Ozempic, which have gained immense popularity as weight loss or diabetes management tools, have no connection to suicidal thoughts or behaviors of FDA
An FDA analysis published on Thursday said, “Our preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions.” Nevertheless, the agency stated that it cannot completely rule out the possibility that “a small risk may exist” and that it will keep an eye on any further reports pertaining to this class of weight-loss treatments, also known as GLP-1 therapies.
Following a National Institutes of Health-funded study, patients receiving semaglutide—the active component of both Ozempic and Wegovy—had a decreased risk of suicidal thoughts compared to those on other medications for diabetes and obesity. This information is relevant to the FDA review.
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In that study, researchers tracked over 240,000 obese people and more than 1.5 million people with type 2 diabetes. They looked at the risk of suicidal ideation within six months of starting the medicines, as well as at later times. At six months, it was found that among people taking the drug for weight loss, semaglutide was linked to a 73% lower risk of first-time suicidal ideation and a 56% lower risk of recurrent suicidal ideation. The drugs that semaglutide was compared to included bupropion, naltrexone, orlistat, topiramate and phentermine. For people with type 2 diabetes, the reductions were 64% and 49%, respectively. Here, the drugs that semaglutide was compared to included insulin, metformin and newer classes of medications known as DPP-4 and SGLT-2 inhibitors.
The author of the study, Dr. Rong Xu, a biomedical informatics professor at Cleveland’s Case Western Reserve University School of Medicine, told CNN that she became interested in the subject last summer when European regulators launched an investigation into semaglutide and complaints of suicidal thoughts. In a research briefing, the researchers stated that although semaglutide was linked to a decreased incidence of suicidal ideation in the NIH study, the data “do not yet justify off-label treatment” for suicidal thoughts. The U.S. prescribing material for Zepbound, a recently approved weight-loss medication, and Wegovy both have cautions regarding the possibility of suicide behavior and ideas.
Frequently asked questions
What are the newest weight-loss drugs?
Over the last decade, the FDA has approved several new weight-loss medicines, including:
- Tirzepatide, or Zepbound.
- Semaglutide, or Wegovy
- Liraglutide, or Saxenda
- Contrave (naltrexone and bupropion)
- Qsymia (topiramate and phentermine)
Some agents have also been prescribed “off-label” for weight loss; that is, your doctor may prescribe an agent for a generally accepted use that is not specifically approved by the FDA or listed on the package labeling. Examples of these agents are Mounjaro (tirzepatide) and Ozempic (semaglutide), which are approved for blood sugar control in type 2 diabetes.
When diet and exercise are insufficient to control weight in adults or children with major health risks (e.g., high blood pressure, type 2 diabetes, high cholesterol), prescription weight-loss medicines may be a viable choice. Medication for weight loss usually entails a regular exercise regimen and a diet with fewer calories and fat.
Do medications for weight loss work?
Wegovy (semaglutide) and Saxenda (liraglutide) are two GLP-1 (glucagon-like peptide-1) receptor agonists that have been approved for the purpose of weight loss. Zepbound (tirzepatide), a GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 receptor agonist, received FDA approval in November 2023. Subcutaneous injections are used to administer them, and they have the potential to cause substantial weight loss. Saxenda is injected once daily, and Wegovy and Zepbound once every seven days.
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Disclaimer: The opinions and suggestions expressed in this article are solely those of the individual analysts. These are not the opinions of HNN. For more, please consult with your doctor
