FDA hits Ozempic and Mounjaro counterfeit compounders with warning letters
Some counterfeits contain bacteria and have high impurity levels or different chemical structures to FDA-approved medicines.
The US Food and Drug Administration (FDA) has sent numerous warning letters to compounding pharmacies for illegally selling semaglutide and tirzepatide, or producing adulterated or misbranded versions. The FDA told the Washington Post that between August 2021 and mid-July 2024, it reviewed 288 reports of patients having bad reactions to compounded semaglutide and 108 such reports for tirzepatide. Some patients required hospitalisation.
Although GLP-1 agonist shortages have been improving recently, manufacturers are still struggling to keep up with high demand for these weight-loss drugs. Some patients are turning to compounding pharmacies when they cannot access the branded version of these drugs due to a shortage or other barriers such as cost and insurance coverage. However, the FDA, Eli Lilly (Indianapolis, IN, US), and Novo Nordisk (Bagsvaerd, Denmark) have all expressed quality and safety concerns with compounded weight loss drugs. The organisations found that some compounded versions of semaglutide and tirzepatide were counterfeit, contained too little, too much or no active ingredient at all, or contained the wrong or harmful ingredients.
Compounding is a well-established practice that allows for the customisation of dosage, formulation and delivery method to meet the specific needs of individual patients, such as for patients with an allergy to one of the inactive ingredients in the approved drug or for a patient who has trouble swallowing a tablet or capsule and needs medicine in a liquid form that is not otherwise available. In certain situations, compounding can be cheaper than purchasing FDA-approved medications, especially for patients who require specialised formulations or dosages. FDA-approved drugs can legally be compounded under certain conditions, though not if patented. The same is true for unapproved drugs. The FDA does allow compounders to make their own version if a drug is in shortage. In May 2023, Ozempic and Wegovy were both listed on the FDA’s drug shortages list, although shortages have lessened since then.
The FDA recognises the substantial consumer interest in using compounded semaglutide products. However, compounded drugs pose a higher risk to patients than FDA-approved drugs because they do not undergo pre-market review for safety, effectiveness or quality. In July 2023, the FDA issued a warning after receiving several reports of adverse effects from people who used compounded semaglutide. It had received reports of dosing errors related to these compounded products. Some patients even sought medical attention or required hospitalisation after the medication error.
In August 2024, Endpoints News reported that Novo had filed 11 new lawsuits against medical spas, weight loss clinics and telehealth companies advertising compounded versions of its semaglutide products for diabetes and weight loss. The lawsuits were filed in California, Florida, Michigan, New Jersey, Oklahoma, Pennsylvania and Washington. The company has now filed a total of 34 legal actions against compounders, six of which have resulted in permanent injunctions.
