A California-based entity is selling compounded drugs used for weight loss and diabetes management that could pose serious health issues for people, according to a warning from the U.S. Food and Drug Administration (FDA).
“Fullerton Wellness is a facility that compounds drugs intended to be sterile, including semaglutide and tirzepatide injections,” the FDA said.
Semaglutide is the active ingredient in the drugs Wegovy and Ozempic manufactured by Novo Nordisk. Tirzepatide is the active ingredient in Mounjaro and Zepbound manufactured by Eli Lilly. While Ozempic and Mounjaro are prescribed for diabetes, Wegovy and Zepbound are for weight loss.
“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,” said the statement.
Administering a non-sterile drug that is intended to be sterile could end up causing “serious and potentially life-threatening” adverse health reactions, the agency warned. Such effects include infections and sepsis, a condition under which the body’s immune system reacts dangerously against an infection.
The FDA said it received a complaint from a patient in August who noticed that a vial of semaglutide distributed by Fullerton had a black particulate.
In September, the agency was informed by California regulatory authorities that deficiencies were found at the company when conducting a state inspection. After the inspection was completed, Fullerton ceased its operations voluntarily.
On Oct. 17, the FDA joined California authorities to inspect the Fullerton facility and check for conditions that could cause the company’s medications to get contaminated.
“Fullerton Wellness used non-sterile ingredients to make these injectable drugs and took no steps to sterilize them which could introduce health risks,” the agency said.
The FDA advised health care professionals to “immediately check” their medical supplies, quarantine any medications from Fullerton, and not to administer these drugs to their patients. Patients who have received supplies from the company were urged to stop using it and consult a health care professional.
The agency noted that it is not aware of any adverse reactions associated with these compounded drugs.
Ongoing Safety Concerns
Last month, the FDA raised concerns about unapproved drugs such as semaglutide and tirzepatide for weight loss purposes. The agency warned that these unapproved versions could be risky since they do not undergo an FDA review checking for safety, quality, and effectiveness.Some of the adverse event reports received by the FDA included people getting hospitalized, which may be related to dosing errors linked to compounded semaglutide, it said. The dosing errors resulted in patients administering themselves with an incorrect dosage of the drug.
In certain cases, the doses exceeded levels approved by the FDA. “Some of the adverse events are serious and some patients reported seeking medical attention for their symptoms, including nausea, vomiting, diarrhea, abdominal pain, and constipation.”
The company said it had conducted tests on the compounded drugs which revealed that they were “adulterated and misbranded.”
Jason Brett, executive director of Medical Affairs at Novo Nordisk, said the corporation saw “concerning levels of unknown impurities” in the compounded semaglutide drugs that could “potentially put patient’s health at risk.”
One of the targets of the legal action was Wells Pharmacy. Certain samples obtained from the pharmacy were found to contain peptide BPC-157, which the FDA had said cannot be used in compounded drugs because of safety issues.
