FDA Investigating Reports of Scary New Ozempic Side Effects
The agency is evaluating unintended reactions associated with popular weight-loss drugs.
Ozempic's rise to fame in the last year has been undeniable—but it hasn't been without controversy. While some celebrities have praised the diabetes drug for helping them drop pounds, others like Sharon Osbourne and Jillian Michaels have warned about the hidden dangers of using it. Many people taking Ozempic and other similar weight-loss drugs have also spoken out about the unpleasant side effects they've experienced. The more alarming claims have prompted a new investigation from the U.S. Food and Drug Administration (FDA). Now, the agency is looking into a few scary side effects in particular, all of which have been linked to popular weight-loss medications.
In a quarterly report released on Jan. 2, the FDA revealed that it's looking into health problems that could be linked to a group of drugs known as GLP-1 receptor agonists. The agency said that it is investigating multiple semaglutide and tirzepatide medications on the market—including Ozempic, Wegovy, Mounjaro, and Zepbound—due to "potential signals of serious risks [and] new safety information identified by the FDA Adverse Event Reporting System (FAERS)."
Between July and Sept. 2023, some patients using these weight-loss and diabetes medications sent reports into FAERS regarding their experience with three specific side effects: alopecia, aspiration, and suicidal ideation. As a result, the FDA said it is now "evaluating the need for regulatory action" in regards to GLP-1 receptor agonists and these reported reactions.
"The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk," the FAERS website states. "It means that FDA has identified a potential safety issue, but it does not mean that FDA has identified a causal relationship between the drug and the listed risk."
As FDA spokesperson Chanapa Tantibanchachai explained to CBS News, this system helps the agency monitor "the safety of drugs throughout their life cycle, including post-approval," as well as "identify and evaluate adverse events that did not appear during the drug development process."
It's not immediately clear if these reactions were caused by the medication, the FDA emphasizes.
"While consumers and healthcare 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 agency says.
When these reactions are determined to be caused by the medication, they can lead the FDA to update the drug's label or call for more research into the reactions.
"If newly identified safety signals are identified, the FDA will determine what, if any, actions are appropriate after a thorough review of available data," Tantibanchachai told CBS News.
In Sept. 2023, for example, the FDA identified several reports of a different side effect from people using semaglutide medications: intestinal obstruction. As a result, the agency issued an update to Ozempic's drug label in Sept. 2023 that mentions adverse reaction reports of ileus, which is the medical term for intestinal obstruction.
Both Novo Nordisk, which manufactures Ozempic and Wegovy, and Eli Lilly, which produces Zepbound and Mounjaro, have acknowledged the FDA's investigation into alopecia, aspiration, and suicidal ideation in people who have used these medications.
"We are aware that, as part of those monitoring efforts, 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 told CBS News.
The company said that it "works closely" with the agency to monitor the safety of their medications.
"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 said.
Meanwhile, a spokesperson for Eli Lilly told the news outlet that these concerns come after "rigorous study for many years in clinical trials and a robust approval process" of their medications.
"Currently, 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," they said.
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