Drug executives say only their GLP-1 drugs are safe for treating obesity and diabetes as they wage a yearlong campaign to stop independent labs from producing cheaper versions.

Former Novo Nordisk CEO Lars Jorgensen testified before Congress last year that these independently compounded GLP-1 drugs have sickened 100 patients and killed 10. He based those numbers on the Food and Drug Administration’s Adverse Event Reporting System, or FAERS.

But advocates for independent pharmacy labs say his conclusion is based on flawed data.

Scott Bruner, CEO of the Alliance for Pharmacy Compounding, told The Baltimore Sun that even the FDA cautions against drawing such conclusions from its adverse event reporting data.

The FDA website states that the self-reporting system includes duplicate and incomplete reports, that no effort is made to verify the events, and that the reports should not be taken to imply a cause-and-effect relationship between the drug and reported effects.

Similarly, like FAERS, in the United Kingdom, data from its self-reporting adverse events to the Medicines and Healthcare Products Regulatory Agency (MHRA) show drugs have been linked to 82 deaths. The study does not differentiate legal or illegal compound drugs. The study reported “22 deaths from adverse reactions associated with use of GLP-1 agonists for weight loss and 60 linked to use for treating type 2 diabetes.”

Alison Cave, MHRA chief safety officer, is quoted in that study as saying, “The decision to start, continue, or stop treatments should be made jointly by patients and their doctor, based on full consideration of benefits and risks.”

While deaths from diseases like flu, RSV and COVID-19 are well documented, no verified reporting covers Americans dying from drugs, including GLP-1s, said Dr. Rozalina McCoy, a practicing adult endocrinologist and researcher at the University of Maryland School of Medicine.

“FAERS is the only FDA sentinel system for approved drugs,” she said. “We need to have pharmacovigilance systems for all medications.”

This type of reporting system would provide a comprehensive, dependable framework for pharmaceutical companies and regulators to detect, assess, understand and prevent adverse effects of medicines.

The FDA first approved GLP-1 drugs – glucagon-like peptide-1 receptor agonists – in 2005 to treat diabetes. Prescriptions took off when they were approved for weight loss in 2014, triggering a national shortage through 2025. About 12% of the adult population or 32 million people in the U.S., take some form of GLP-1. During a shortage, or when patients need a special formulation not otherwise available, independent labs called compounding pharmacies can fill that prescription.

A 2024 paper published by the Cureus Journal of Medical Science analyzed FDA adverse event reporting data to zero in on deaths connected to GLP-1 drugs.

The authors, from Miller Scientific and the University of California, Los Angeles, found an increased possibility of deaths related to the earliest approved GLP-1 drugs: Byetta, with 1,571 related deaths over 20 years, and Victoza, with 1016 deaths in 15 years.

Higher levels of negative reactions were associated with semaglutide products Ozempic, Rybelsus, and Wegovy, as well as liraglutide products Victoza, Saxenda, and Byetta.

The approved versions of GLP-1 drugs carry other risks, and perhaps benefits.

A January update to an FDA drug safety statement suggested doctors monitor patients for depression or suicidal thoughts as a precaution in line with the product labeling.

“Our preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions,” the statement says.

A Feb. 20 explainer in the journal Nature said previously reported warnings about deaths from inflammation of the pancreas cannot be clearly connected to GLP-1 use.

On the other hand, a Nov. 11, 2025 study by the University of California, San Diego found compelling evidence that colon cancer patients on GLP-1 drugs had a reduced chance of dying from the cancer within five years — 15.5% for those taking the drugs, compared with 37.1% otherwise.

These reports involve FDA-approved GLP-1 drugs.

Recent agency moves to restrict compounded versions prompted pushback from those representing compounders, who say their products are being mischaracterized.

“Compounding pharmacies can document their process, potency and the purity of the active ingredient they have used,” Bruner told The Sun. “Part of the concerns about what is going on related to compounded GLP-1 drugs is related to substances that aren’t compounded drugs at all.”

Many questionable online sources offer versions of these drugs, he said, and nobody knows what they contain.

While the FDA declared the GLP-1 shortage over, that does not mean the medications are easy to obtain for all patients, said Dr. McCoy.

“Now it’s really a matter of access, because of the cost,” McCoy told The Sun. “Many insurance companies are not covering these drugs for weight loss.”

Novo Nordisk now offers its medications at $150 per month to people without insurance approval.

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