Popular weight-loss drugs included in FDA investigation: What to know
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Key takeaways:
- An FDA quarterly report showed that the agency is investigating potential safety signals of some headline-making weight-loss drugs.
- The agency is not suggesting PCPs stop prescribing the drugs in the meantime.
An FDA investigation of popular weight-loss drugs has generated a storm of media attention and prompted patient questions.
In its quarterly report, which was released on Jan. 2, the agency revealed it is looking into potential safety signals of popular weight-loss drugs like Ozempic (semaglutide, Novo Nordisk), Wegovy (semaglutide, Novo Nordisk) Mounjaro (tirzepatide, Eli Lilly), Zepbound (tirzepatide, Eli Lilly) and Saxenda (liraglutide, Novo Nordisk). Semaglutide and liraglutide are both GLP-1 receptor agonists, whereas tirzepatide is a GIP/GLP-1 dual agonist, which has a different mechanism of action.
According to the quarterly report, the FDA is investigating reports of the hair loss condition alopecia, suicidal ideation and aspiration. The weight-loss medications are not the only ones being investigated; many others for a variety of conditions are also on the list.
Notably, a drug’s appearance on the list does not mean that the agency has concluded that the drug has the listed risk — a point the agency wrote it “wants to emphasize.”
“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,” according to the report. “FDA is not suggesting that health care providers should not prescribe the drug or that patients taking the drug should stop taking the medication while an evaluation of the potential safety issue is being conducted.”
Research was published Jan. 5 in Nature Medicine evaluating concerns of suicidal ideation associated with semaglutide treatment. The retrospective cohort study, including 240,618 patients, revealed that, compared with non-GLP-1 agonist anti-obesity medications, semaglutide was linked to a lower risk for both recurrent suicidal ideation (HR = 0.44) and incident suicidal ideation (HR = 0.27). The researchers wrote that their findings “do not support higher risks of suicidal ideation with semaglutide compared with non-GLP1R agonist" anti-diabetes or anti-obesity drugs.
In a statement to Healio, Novo Nordisk (Ozempic, Saxenda and Wegovy’s manufacturer) said the safety of patients “is the top priority” for the company, and that it “works closely with the U.S. FDA to continuously monitor the safety of all of our GLP-1RA medicines.”
“We are aware that, as part of those monitoring efforts, FDA is evaluating several potential signals related to GLP-1RA medicines and has posted information about those ongoing assessments on its website,” according to the statement. “Novo Nordisk stands behind the safety and efficacy of all of our GLP-1RA medicines when they are used as indicated and when they are taken under the care of a licensed health care professional.”
A spokesperson for Eli Lilly, the manufacturer of Zepbound and Mounjaro, told Healio “patient safety is our priority.”
“Following rigorous study for many years in clinical trials and a robust approval process, medicines continue to be monitored by the FDA and manufacturers for safety. When the FDA identifies a potential safety issue, it creates a Newly Identified Safety Signal for evaluation. Currently, the FDA is reviewing data on certain potential risks for GLP-1 receptor agonist medicines,” the spokesperson said. “We are collaborating with the FDA on these potential signals.”
An open letter from the company also stated that it “stands against the use of its medicines for cosmetic weight loss.”
If the FDA determines after further evaluation that the drugs are linked to any of the risks being investigated, the agency “may take a variety of actions, including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy, or gathering additional data to better characterize the risk,” according to the report.
Editor’s note: On Jan. 11, 2024, the FDA announced that a preliminary review of evidence did not identify a causal link between popular weight-loss drugs and suicidal thoughts or actions. Read more.
References:
- FDA. https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/july-september-2023-potential-signals-serious-risksnew-safety-information-identified-fda-adverse. Published Jan. 2, 2024. Accessed Jan. 4, 2024.
- Open letter regarding the use of Mounjaro (tirzepatide) and Zepbound (tirzepatide). https://investor.lilly.com/news-releases/news-release-details/open-letter-regarding-use-mounjaror-tirzepatide-and-zepboundtm. Published January 4, 2024. Accessed Jan. 4, 2024.
- Potential signals of serious risks/new safety information identified from the FDA Adverse Event Reporting System (FAERS). https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/potential-signals-serious-risksnew-safety-information-identified-fda-adverse-event-reporting-system. Accessed Jan. 4, 2024.
- Wang W, et al. Nat Med. 2023;doi:10.1038/s41591-023-02672-2.
Perspective
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Fatima Cody Stanford, MD, MPH, MPA, MBA, MACP, FAAP, FAHA, FAMWA, FTOS
I am unsurprised that the FDA has chosen to investigate the safety of GLP-1 single and dual agonist medications. These medications gained tremendous popularity in 2023, but unfortunately, they were often used in unsafe manners for various reasons. For example, many medications are being compounded due to high costs and lack of availability. Yet, these medications have never been studied. We don’t know if they are safe. Also, there have been major shortages of the medications manufactured by key pharmaceutical companies. Patients often skip over to high doses secondary to these shortages, leading to significant side effects.
The medications being investigated are safe — they reduce the risk of major adverse coronary events, heart attacks, strokes, all-cause mortality and other issues. These medications are approved for patients with obesity and type 2 diabetes.
PCPs should be aware that these medications are a tool for the treatment of obesity and type 2 diabetes, but they need to be aware of the side effects and contraindications. They should also be aware that the medications should be used long term if they are efficacious for weight or blood sugar improvement.
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Potential signals of serious risks/new safety information identified from the FDA Adverse Event Reporting System (FAERS). https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/potential-signals-serious-risksnew-safety-information-identified-fda-adverse-event-reporting-system. Accessed Jan. 4, 2024.
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