Rising popularity of Novo Nordisk's Ozempic is making it more difficult to find, leaving some patients to turn to unauthorized alternatives, The New York Times reported May 16.
Originally developed as a treatment for Type 2 diabetes, Ozempic and Eli Lilly's Mounjaro have both proven to be effective for aiding patients with weight loss, fueling the rise in demand. While neither are officially approved for that purpose, an April 3 report from The Wall Street Journal predicted "In the coming months, it is widely expected to get the go-ahead from U.S. health regulators to be prescribed for losing weight and keeping it off."
While current supply of the drug is not keeping up with demand, patients seeking a solution have sometimes turned to promises from individuals claiming to be physicians on social media who promise a generic form of it, according to the Times.
The issue though is two-fold in that there is currently not an FDA-approved generic version of Ozempic and Novo Nordisk also does not sell semaglutide — what the drug is made from — to any pharmacy for compounding or mixing purposes. Regulators worry that individuals receiving what was promised to be an Ozempic alternative on social media may be at risk, according to the Times.
Since a shortage of Ozempic is occurring, compounding pharmacies that reformulate drugs are allowed to purchase ingredients and compounds — including semaglutide — to aim to curb the shortage. However, experts are concerned since "semaglutide sodium does not appear to meet standards for compounding in federal law, in part because the substance is not part of any F.D.A.-approved medication," the Times article states.
"The F.D.A. does not vet compounded medications, and has not reviewed, approved or tested — for safety or effectiveness — the semaglutide drugs compounding pharmacies offer," according to the Times.
Several states have begun to issue warnings and statements on the matter in the hopes that it will deter compounding pharmacies from continuing their production of the off-brand, unapproved Ozempic-like medications. To crack down further, Novo Nordisk is also taking action and may even issue cease-and-desist orders to the compound makers, the Times reported.