The Food and Drug Administration (FDA) announced this week that it is investigating potential safety concerns with popular diabetes and weight loss medications after receiving multiple reports of serious side effects. The agency said it has seen a rise in adverse events like hair loss and suicidal thoughts and behaviors associated with drugs like Ozempic, Wegovy, and Mounjaro.
Background on the Medications
Ozempic, Wegovy, Mounjaro and other similar medications belong to a class of drugs called GLP-1 receptor agonists. They work by mimicking a hormone called glucagon-like peptide-1 to lower blood sugar levels.
These injectable drugs have been growing in popularity over recent years as doctors increasingly prescribe them not just for type 2 diabetes, but also for chronic weight management. In 2021 and 2022 in particular, the drugs gained attention on social media among people taking them for weight loss purposes, which likely contributed to the uptake.
Overview of the Safety Investigation
In a safety announcement on January 3rd, 2023, the FDA stated it has received a number of reports of adverse events tied to Ozempic (semaglutide), Wegovy (semaglutide), and Mounjaro (tirzepatide). The most frequently reported issues include:
- Hair loss
- Suicidal thoughts and behaviors
- Diabetic retinopathy complications
The agency emphasized that it has not established a causal link between the drugs and these side effects. However, due to a rise in reports, it is now further evaluating the potential risks.
“We are requiring warnings about additional potential risks to health professionals and patients,” said Sally Hojvat, director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research.
Latest Updates on the Investigation
Since the FDA announcement earlier this week, new details have continued to emerge:
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On January 4th, Novo Nordisk, the manufacturer of Ozempic and Wegovy, stated it is working closely with the FDA on assessing any potential link between its drugs and psychological side effects. The company maintains the existing evidence does not establish causation.
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Poison control centers in multiple states like Arizona and Florida report spikes in calls for accidental Overdoses and side effects. They attribute this to growing off-label use of medications like Ozempic for weight loss.
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New analyses find these drugs lead to modest weight reduction (5-15% on average) for most patients taking them solely for obesity. Doctors advise combining the drugs with nutrition and lifestyle changes for optimal fat loss.
| Drug | Manufacturer | Approved Uses |
|---|---|---|
| Ozempic | Novo Nordisk | Type 2 diabetes, chronic weight management |
| Wegovy | Novo Nordisk | Chronic weight management |
Mounjaro | Eli Lilly | Type 2 diabetes |
Expert Analysis
Medical experts are urging caution until more evidence is available, though they continue to consider GLP-1 drugs promising for diabetes and obesity:
“We need more research to clarify if these medications directly cause psychological side effects and if so, what factors put certain patients more at risk,” said Dr. Meredith Hawkins, an endocrinologist at Albert Einstein College of Medicine.
Dr. Fatima Cody Stanford, obesity medicine specialist at Massachusetts General Hospital, stated: “While reports of suicidal ideation are concerning, current data is not conclusive… For appropriate patients, there is still demonstrated benefit for weight loss and diabetes control when combined with lifestyle improvements.”
Both doctors concurred patients should speak to their provider immediately if they experience any neuropsychiatric changes or rapid hair loss after starting GLP-1 drug treatment.
What Happens Next
In its safety announcement, the FDA shared several next steps:
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Manufacturers of GLP-1 drugs will be required to add warnings about potential adverse effects to prescription labels and medication guides
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Healthcare professionals are advised to monitor patients for side effects and report any incidents
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The agency will continue its epidemiological review to establish whether a causal relationship exists between the reported events and the medications
As the FDA gathers more data, there may be updated guidelines for safe prescribing of GLP-1 drugs for doctors. It remains unclear if use restrictions will be introduced for the general public depending on the strength of evidence for risks.
With obesity on the rise globally, regulators face pressure to balance this with safety oversight of new anti-obesity treatments entering the market. The FDA investigation into Ozempic, Wegovy and related drugs will likely influence the landscape for next-generation obesity pharmacotherapies.
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