Popular Weight-Loss Drugs Distributed In IE Flagged By FDA

ONTARIO, CA — Popular weight-loss treatments — like Lilly's Zepbound and Novo Nordisk's Wegovy — have fueled demand from consumers who want to shed unwanted pounds. As a result, many drug-compounding companies have jumped on the revenue bandwagon to distribute generic products.

But the U.S. Food and Drug Administration on Friday once again warned that these compounded weight-loss drugs could harm patients.

The latest federal red flag stems from contamination concerns at a Southern California compounding facility. According to the FDA, injectable semaglutide and tirzepatide compounded and distributed by Ontario, Calif.-based Fullerton Wellness LLC may not be sterile.

"Based on conditions observed by FDA and information provided by California regulatory authorities, FDA has concerns about the sterility of drugs distributed by Fullerton Wellness," according to a Nov. 1 FDA warning. "Fullerton Wellness used non-sterile ingredients to make these injectable drugs and took no steps to sterilize them which could introduce health risks.

"Administration of a non-sterile drug intended to be sterile may result in serious and potentially life-threatening adverse health consequences including infections and sepsis," the FDA warned.

Injectable tirzepatide is marketed under Lilly's Mounjaro and Zepbound products, and injectable semaglutide is marketed under Novo Nordisk's Ozempic and Wegovy. The GLP-1 (glucagon-like peptide-1 receptor agonists) drugs are FDA-approved and no safety warnings were issued for them as part of the Nov. 1 announcement.

Instead, it's the compounded versions of the drugs that are prompting alerts. Drug compounding is the process of mixing, combining or altering ingredients. Compounding can be a critical safety net when FDA-approved drugs are unavailable, but compounded drugs aren't FDA-approved and are instead state-regulated.

Concerns about Fullerton Wellness date back to August 14, after the FDA received a complaint from a patient who noticed "a black particulate" in a vial of compounded semaglutide distributed by the company. Then, on September 23, the FDA received information from California regulatory authorities about "deficiencies" at Fullerton Wellness during a state inspection, the FDA reported.

On October 17, the FDA joined state authorities at the Ontario facility and "observed conditions that could cause the drugs produced by the company to become contaminated," the FDA advised.

Patch called Fullerton Wellness on Monday, but the phone number was disconnected. According to the FDA, Fullerton Wellness voluntarily ceased operations.

The FDA urges healthcare professionals to check their medical supplies and stop administering any Fullerton Wellness products.

"Patients who have received compounded drugs distributed by Fullerton Wellness should stop using them and contact their health care professional," according to the FDA.

The recent advisory about compounded GLP-1 drugs wasn't the first. In July, the FDA issued a warning to patients and healthcare professionals using unapproved versions of the drugs for weight loss.

"This can be risky for patients, as unapproved versions do not undergo FDA’s review for safety, effectiveness and quality before they are marketed," according to the federal agency.

The FDA said in July that it is working with its state regulatory partners and "will continue to communicate with compounders regarding these concerns."

Patients and healthcare professionals should report any adverse drug reactions to FDA’s MedWatch program:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm
• Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178.