The diabetes advocacy group recommends against the use of compounded GLP-1 medications

The American Diabetes Association, a high-profile advocacy group, is warning about the widespread use of compounded versions of popular weight-loss and diabetes medications like Wegovy and Zepbound.

The group released an official guidance statement Monday recommending that doctors avoid prescribing unapproved brand-name versions of the drugs, which have been in such demand that their makers, Novo Nordisk and Eli Lilly, have struggled to maintain supplies.

“We urge healthcare professionals to consider this guidance because of concerns about the safety, quality and effectiveness of compounded versions of these products,” said Joshua Neumiller, the ADA’s president-elect and co-author of the statement.

Compounded versions of the drugs may not meet Food and Drug Administration standards for drug content, safety, quality or effectiveness, the ADA said. Manufacturers have added additional ingredients such as vitamins B12 and B6 or used salt forms of the prescription active ingredients, leading to dosing errors and adverse events, according to the group.

“We encourage healthcare professionals and people with diabetes and obesity to consider these guidelines in conjunction with clinical judgment and individual preferences when making informed care decisions,” said Nuha ElSayed, ADA vice president for health care improvement, in a statement.

Wegovy contains semaglutide, an active ingredient also marketed by Novo as Ozempic for the treatment of type 2 diabetes. Similarly, Eli Lilly sells the active ingredient tirzepatide as Mounjaro for diabetes and Zepbound for obesity. Both medications are also referred to as incretin therapies or alternatively as GLP-1 agonists.

They have proven to be extremely effective in weight management and further testing has shown other notable health benefits such as: B. reducing heart risk with Wegovy and helping to control sleep apnea with Zepbound. As a result, demand has skyrocketed, leading to periodic supply shortages over the past two years as Novo and Lilly struggled to produce enough doses.

The shortages have led doctors and patients to turn to compounding pharmacies, which make customized preparations of approved products under specific FDA regulations that permit their manufacture.

In issuing this statement, the ADA, whose members include physicians, health educators and community health workers, has cast an important voice in a dispute that has engulfed the FDA and drug pharmacies in recent months.

The FDA currently lists Wegovy and Ozempic as available and officially ended the shortage of Zepbound and Mounjaro in October. This latest move came with a warning to compounders that legal bans on their formulations were back in effect.

But the Outsourcing Facilities Association, an industry group representing compounders, quickly sued the FDA, and the agency stopped enforcing the law. It has promised to review its decision to remove Zepbound and Mounjaro from the shortage list and has agreed to postpone any action until December 19.

Former FDA Commissioner Scott Gottlieb has criticized the FDA for continuing to approve compounded versions of tirzepatide, accusing it of using the price of brand-name drugs as an excuse to roll back compounding regulations mandated by the Drug Quality and Security Act.

Meanwhile, Hims and Hers, which sells compounded semaglutide, has been running weekly ads in the New York Times about the obesity epidemic, highlighting the disruption that could occur if the FDA cracks down on compounded versions of GLP-1.