The regulator says drug compounders are selling products that falsely claim to contain the same active ingredient, semaglutide, as the blockbuster diabetes and obesity drugs.
Pictured: FDA sign in front of building/Adobe Stock/Grandbrothers
The FDA has warned that drug compounders are selling products that falsely claim to contain semaglutide, the same active ingredient as Novo Nordisk’s blockbuster diabetes and obesity drugs Ozempic and Wegovy their oral sibling Rybelsus.
U.S. law allows pharmacies to manufacture and provide unapproved versions of drugs in short supply under certain circumstances. Demand for products containing semaglutide has surged as evidence of its effect on obesity has emerged, creating supply issues for Novo Nordisk and an opportunity for compounders.
Wednesday, the FDA published a notice about compounders that have stepped in to meet demand for the glucagon-like peptide-1 receptor agonist semaglutide. The agency released the statement after receiving reports that some drug compounders may be using unapproved salt forms of semaglutide. Only the base form of the ingredient is approved in the U.S.
Different salt forms can have various effects, leading the FDA to categorize them as distinct active pharmaceutical ingredients. The regulator wrote to the National Association Boards of Pharmacy in late April to discuss reports that compounders are using unapproved forms of semaglutide, stating that there is no basis in U.S. law for compounding a drug using the salts, as far as it is aware.
In going public with its concerns, the FDA reiterated the message it sent to the pharmacy association. The agency has received adverse event reports after patients used compounded semaglutide, although it has yet to say whether the cases involved the salt form of the ingredient. It is also unclear whether the side effects were linked to the compounding process or the risks inherent to all forms of semaglutide.
The situation may resolve itself as the supply of Ozempic and Wegovy improves. While both products are still listed in the FDA’s shortage database, Novo Nordisk has gone some way to ensuring patients can get hold of the products. Three of the four doses of the diabetes drug Ozempic are available, with the fourth being discontinued and patients transitioned to the other products.
According to the FDA, the two highest doses of the weight management drug Wegovy are available but supply of the three lower doses will be limited until September. Novo Nordisk has said that, while it has “taken significant measures to increase capacity,” it can currently only provide limited quantities of the three lower doses and will not meet anticipated demand through September.
Nick Paul Taylor is a freelance pharmaceutical and biotech writer based in London. He can be reached on LinkedIn.
