Buyer Beware: Compounded and Fake Semaglutide
Unfortunately, we are facing the new year with a great demand for advanced new obesity medicines and an inadequate supply. On the FDA drug shortages website, all strengths of the Wegovy brand, except 2.4 mg, have limited availability. Both Wegovy and Ozempic are “currently in shortage.” This opens the door for compounded semaglutide and a classic case of buyer beware.
On top of that, counterfeit semaglutide sneaks in to make the things worse – compounding the problem, so to speak.
A Legal Option Because of the Shortage
To be clear, compounding pharmacies are legally allowed to prepare doses of a drug like semaglutide when the FDA determined the drug is in shortage. Currently, this is the case for semaglutide. But it should not be a Wild West situation. State Boards of Pharmacy regulate compounding pharmacies. These pharmacies must meet provisions of the Federal Food, Drug, and Cosmetic Act. They have to use ingredients that are suitable for clinical applications.
Many or Most of These Offerings Are Sketchy
The fact is that many or perhaps most of the offerings of compounded semaglutide are sketchy. FDA has received numerous reports of adverse events. The agency has warned the National Association of Boards of Pharmacy that some pharmacies are illegally using semaglutide salts which have not been studied for safety and effectiveness.
Novo Nordisk, the maker of Ozempic and Wegovy, is taking aggressive legal action against compounding pharmacies, medical spas, and clinics for false advertising, trademark infringement, and unlawful sales of adulterated and misbranded drugs claiming to contain semaglutide.
Not Recommended
This situation is nothing short of an awful mess. The Obesity Society, the Obesity Medicine Association, and the Obesity Action Coalition all flatly say, “We do not recommend use of these alternatives.”
We Deserve Better
The present situation is deplorable and there is plenty of blame to go around. We will start with the inadequate supply situation. Novo Nordisk allowed itself to be surprised by the unmet need for obesity care and the demand for its products – even though the company spent years building this demand. This is the fundamental failure that opened the door to this problem.
Then we have the unscrupulous business practices of compounding pharmacies and medical spas that sell products with unverified quality, ingredients, and safety. In the words of FDA:
“Unnecessary use of compounded drugs unnecessarily exposes patients to potentially serious health risks.
“Because compounded drugs are not FDA-approved, FDA does not verify their safety, effectiveness, or quality before they are marketed. In addition, poor compounding practices can result in serious drug quality problems, such as contamination or a drug that contains too much active ingredient. This can lead to serious patient injury and death.”
The Alliance for Pharmacy Compounding naturally defends the dispensing of compounded semaglutide and suggests that patients can ask for a certificate of analysis and analytical testing results for such preparations.
In the end, buyer beware may not be adequate protection for people considering compounded semaglutide. It will be a rare patient who can decipher a certificate of analysis or analytical testing results.
Click here for perspective from Science, here for case reports of problems with compounded semaglutide, here for reporting from the New York Times, and here for a legalistic and thorough explanation from the New Jersey Attorney General. For information on this situation from the Obesity Medicine Association, click here.
Syringe, photograph by ZaldyImg, licensed under CC BY 2.0
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January 9, 2024
