Proactive compliance reviews of promotional materials may help reduce regulatory risk as FDA continues to monitor this evolving market. Rebecca Zadaka, Associate Attorney, Gardner Law How Gardner Law Can Help FDAs recent warning letters underscore the regulatory risk associated with compounded GLP-1 marketing, particularly where promotional claims overstate product status, safety, effectiveness, or comparability to approved drugs
Surprising Fact The weight loss drug Wegovy could lower the risk of adverse cardiovascular events by 20%, according to data from a trial shared by Novo Nordisk in August
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Even prior to the crackdown on compounded medications, there was a robust online ecosystem of unlicensed pharmacies selling counterfeit drugs or research-grade ingredients meant to be used in a lab rather than taken by humansand as compounded semaglutide and tirzepatide get harder to find, people who were previously taking legal copycats are considering more extreme options
This translates to stronger appetite suppression, more pronounced satiety signals, and greater reduction in food intake
Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic amounts of growth hormone
