Hundreds of people taking compounded GLP-1 drugs — unapproved versions of brand-name weight loss medications — have reported “adverse events,” with some health issues requiring hospitalization, according to the U.S. Food and Drug Administration (FDA).
Dosing Errors May Be More Common With Compounded GLP-1s
Multiple adverse event reports were related to dosing mistakes with compounded semaglutide injections, which resulted from patients self-administering incorrect doses or healthcare providers miscalculating doses, the FDA said.
Melanie Jay, MD, a professor at New York University and the director of the NYU Langone Comprehensive Program on Obesity Research, points out that most brand-name drugs come in prefilled pens that make it relatively simple to “dial up” the right dose by twisting a knob. People using compounded GLP-1s, however, typically draw the medication from a vial with a syringe.
“When patients have to fill their own syringes, there are more opportunities for dosing errors,” Dr. Jay says.
Some adverse event reports were also related to patients being prescribed doses of compounded semaglutide or tirzepatide that were higher than those for the FDA-approved versions of these drugs, the FDA said.
In some instances, the side effects were serious enough for patients to require medical treatment for symptoms such as nausea, vomiting, diarrhea, abdominal pain, and constipation, the FDA said. Other patients experienced side effects such as redness, swelling, or pain at the injection site.
How Common Are Adverse Events From Compounded GLP-1s?
An FDA spokesperson contacted by Everyday Health didn’t provide additional information to quantify the risk of compounded GLP-1 drugs, such as the total number of people taking compounded GLP-1 medicines or the proportion of these patients who experienced adverse events.
“It’s really hard to get a handle on the actual number of prescriptions and adverse events, including serious adverse events, among people who use compounded semaglutide and tirzepatide,” says Jody Dushay, MD, an endocrinologist and an assistant professor at Harvard Medical School and Beth Israel Deaconess Medical Center in Boston.
“If I had to guess, I’d say this is the tip of the iceberg in terms of adverse events, and I think there is an even larger number of people who are not getting any benefit from these medications,” Dr. Dushay says.
One reason adverse events for compounded GLP-1 drugs are probably underreported is that people who prescribe or sell these drugs don’t hear from patients when there are problems, Dushay says. It’s also likely that some places selling compounded GLP-1 drugs don’t report side effects they learn about to the FDA, Dushay adds.
How to Spot a Fraudulent Compounded GLP-1
The FDA encourages the following safety measures:
- Carefully check labels of compounded GLP-1 drugs for warning signs of a counterfeit medication, such as spelling errors or incorrect addresses, and ensure your medicine is from a licensed pharmacy and prescribed by a licensed healthcare provider.
- If you receive a product with a licensed pharmacy name on the label that you think might be fraudulent, contact the pharmacy to ask if it is their product.
- Talk to your doctor if you have questions about your medicines.