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FDA Looking Into New Risks With Popular Weight-Loss Drugs
  • Posted January 4, 2024

FDA Looking Into New Risks With Popular Weight-Loss Drugs

The U.S. Food and Drug Administration is investigating reports of additional dangers linked to several wildly popular weight-loss drugs.

In a quarterly report issued this week, the agency said it is investigating cases of hair loss; aspiration (when food or other objects get into the airways); and suicidal ideation in people who used the medications. Some of the drugs in this class, known as GLP-1 receptor agonists (GLP-1 RA), include Ozempic, Wegovy, Mounjaro and Zepbound.

While these reports can turn out to be false alarms, previous investigations have prompted the FDA to update a drug's labeling or call for additional study on the issue.

This isn't the first time the agency has looked into potential complications with these weight-loss drugs: Last year, the agency investigated reports of intestinal obstructions linked to the medications. Ozempic's labeling was subsequently updated to acknowledge that risk, CBS News reported.

"We are aware that, as part of those monitoring efforts, [the] FDA is evaluating several potential signals related to GLP-1 RA medicines and has posted information about those ongoing assessments on its website," a spokesperson for Novo Nordisk, which makes Ozempic and Wegovy, told CBS News.

"Novo Nordisk stands behind the safety and efficacy of all of our GLP-1 RA medicines when they are used as indicated and when they are taken under the care of a licensed healthcare professional," the spokesperson added.

A spokesperson for Eli Lilly, which produces Zepbound and Mounjaro, told CBS News the "FDA is reviewing data on certain potential risks for GLP-1 receptor agonist medicines. Patient safety is our priority, and we are collaborating with the FDA on these potential signals."

Through September, there have been 201 reports of suicide or suicidal ideation among patients taking medications with semaglutide, the key ingredient in Ozempic and Wegovy, or tirzepatide, the key ingredient for Zepbound and Mounjaro.

Meanwhile, there have been at least 422 reports of hair loss. A number of other medications have been linked to hair loss, including some antidepressants and birth control pills, CBS News reported.

A less common danger has also been reported to the FDA: There were 18 cases of patients taking semaglutide or tirzepatide that mention aspiration, when people accidentally inhale food or other objects into their airways.

In a case report published in March, Canadian doctors said a patient who had too much food left in the stomach despite fasting for 18 hours before an operation. Two months earlier, the patient had begun injections of semaglutide for weight loss.

In June, the American Society of Anesthesiologists called for patients to stop taking these weight-loss medications before elective operations because of this potential complication.

More information

Visit Drugs.com for more on weight-loss drugs.

SOURCE: U.S. Food and Drug Administration, quarterly report, FDA Adverse Event Reporting System, July-September 2023; CBS News

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