One week after the Food and Drug Administration published that it was investigating a link between popular weight loss drugs and suicidal ideation, the FDA said a preliminary evaluation found no evidence that the medicines cause suicidal thoughts or actions.
The FDA said that it has been reviewing reports of suicidal thoughts and ideation among users of weight loss and diabetes drugs that use GLP-1 RAs. Suicidal thoughts were not considered a common side effect during clinical studies.
"We determined that the information in these reports did not demonstrate a clear relationship with the use of GLP-1 RAs. Similarly, our reviews of the clinical trials, including large outcome studies and observational studies, did not find an association between use of GLP-1 RAs and the occurrence of suicidal thoughts or actions," the FDA said.
The FDA added that it cannot definitively rule out that a small risk exists, so the FDA cautioned that its evaluation is preliminary.
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The FDA's Adverse Event Reporting System report last week included popular drugs such as Mounjaro, Ozempic, Trulicity, Victoza and Wegovy. In addition to suicidal ideation, the FDA said it was investigating a connection between the drugs and hair loss and aspiration (the act of having food or drinks go down the wrong tube).
The FDA says just because a drug is on the report does not mean that the drug caused the reaction in question.
"While consumers and health care professionals are encouraged to report adverse events, the reaction may have been related to the underlying disease being treated, or caused by some other drug being taken concurrently, or occurred for other reasons. The information in these reports reflects only the reporter's observations and opinions," the FDA said.
Known side effects that presented themselves in clinical trials include numerous adverse gastrointestinal reactions. Headaches, sore throat and tiredness can also be side effects of these drugs.
Many of these drugs were initially prescribed to help manage Type 2 diabetes but have since gained popularity to help patients manage weight.
According to the Cleveland Clinic, these medications help manage blood sugar levels by triggering insulin release from the pancreas. The drugs also help slow digestion, which causes less glucose to enter the bloodstream. The medicine also affects satiety, allowing patients to feel full after eating, the Cleveland Clinic said.
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