Tens of thousands of individuals who depend on lower-cost, compounded forms of Ozempic and Wegovy, the two medicines used to manage Type 2 diabetes and for weight loss, may be impacted by the FDA’s recent landmark ruling.
The active ingredient in each medication is semaglutide, and the generic versions of those medications have long been manufactured with it using compounding pharmacies. This technique, which offered a less expensive substitute for the original prescriptions, started in 2022 when there was a shortage of the brand-name medications. The FDA is now prohibiting the manufacture and distribution of these compounded versions, formally ending the shortage.
What Are Ozempic and Wegovy?
As GLP-1 receptor agonists, both Wegovy and Ozempic work through mimicking a hormone that helps control blood sugar as well as inducing hunger reduction. Wegovy is especially designed to result in patients becoming thinner, with Ozempic being approved for addressing Type 2 diabetes. While the drug was technically not prescribed for weight loss purposes, several of the patients utilized it for exactly the same, something that led to their widespread popularity now.
Both medicines control blood glucose and weight by slowing stomach emptying, prolonging sensations of fullness. The same category of medications, such as Mounjaro, is also prescribed to promote weight loss in the UK, but only for diabetes; in most parts is prescribed for Ozempic.
The FDA Choice’s Effect
Many people have found that the compounded forms of these medications are their lifeline. They are frequently easier to obtain and cheaper than name-brand versions. Americans expended a whopping $71 billion on diet drugs alone in 2023, evidencing the mounting demand for good treatments like Ozempic and Wegovy.
Compounded drug patients, though, might not be able to obtain their usual supplies after the FDA’s new regulation. Most are frantically looking for alternatives, while larger compounding pharmacies have until May 22 to comply with the new requirements.
What Should Patients Do Next?
As per NBC News’ medical contributor Dr. Natalie Azar, if you are on a compounded form of Ozempic or Wegovy, consult with your pharmacist. Moreover, patients may be able to work with their healthcare professionals for other options, perhaps switching medications or lowering the dose, although it is not clear how strictly we enforce this directive. Other options exist: Saxenda, Contrave, and Qsymia, all of which have their risks and side effects.
Owing to the high costs associated with the brand names, pharmaceutical companies such as Novo Nordisk, producers of Ozempic and Wegovy, offer patient assistance programs that may help reduce these costs for those worried about the cost.
While bariatric surgery may be an option in some cases after all other avenues of weight loss, whether diet and exercise, have been exhausted, it should typically be seen as a last resort.
What’s Next
The FDA’s move is just one part of a larger effort to oversee compounded drugs. With comparable due dates for compounding pharmacies, the FDA addressed its scarcity of another class of GLP-1 medications in December 2024, including Mounjaro, which is based on tirzepatide.
The discussions surrounding availability, affordability, and regulation are probably going to keep shifting as more patients use weight-loss drugs. In the meantime, patients relying on compounded drugs will have to adjust to a different landscape, which may involve switching drugs, changing dosages, or seeking alternative ways to lose weight.
