Diabetes advocacy group discourages use of compounded GLP-1 drugs
The American Diabetes Association recommended doctors prescribe alternative FDA-approved drugs as Wegovy and Zepbound remain difficult to reliably obtain.
The American Diabetes Association, a high-profile advocacy group, is warning against widespread use of compounded versions of popular weight loss and diabetes drugs like Wegovy and Zepbound.
The group on Monday released an official guidance statement that recommends doctors avoid prescribing unapproved, off-brand versions of the medicines, which have been so in demand their manufacturers, Novo Nordisk and Eli Lilly, have had difficulty keeping up supply.
“We urge health care professionals to consider this guidance statement due to concerns around the safety, quality, and effectiveness of compounded versions of these products,” said Joshua Neumiller, the ADA’s president-elect and a 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. Compounders have added extra ingredients like vitamins B12 and B6, or have used salt forms of the active prescribing ingredients, leading to dosing errors and adverse events, according to the group.
“We encourage health care professionals and people living with diabetes and obesity to consider this guidance in conjunction with clinical judgment and individual preferences when making informed care decisions,” said Nuha ElSayed, the ADA’s senior vice president for health care improvement, said in a statement.
Wegovy contains semaglutide, a drug ingredient also marketed by Novo as Ozempic for use treating Type 2 diabetes. Similarly, Eli Lilly sells the compound tirzepatide as Mounjaro for diabetes and Zepbound for obesity. Both drugs are also known as incretin therapies or, alternatively, GLP-1 agonists.
They’ve proved powerfully effective at controlling weight and further testing has shown other notable health benefits, such as reducing heart risk for Wegovy and helping control sleep apnea for Zepbound. Demand has soared as a result, leading to periodic short supply over the past two years as Novo and Lilly have struggled to make enough doses.
The shortages have prompted physicians and patients to turn to compounding pharmacies, which make custom preparations of approved products under specific FDA rules permitting their production.
In making the statement, ADA, which includes physicians, health educators and community health workers in its membership, has added a major voice over a dispute that has gripped the FDA and compounding pharmacies over the past few months.
Filed under: General Problems
My husband tried Ozempic. It caused him immediate GI problems. When looking into it, it appears that when people take Ozempic they will immediately drop about 12 pounds. Then they revert back to one to 4lbs a month just like they would if they were just eating a good diet and exercising. Considering the horrific potential side effects and the astronomical cost, my own personal opinion for what it’s worth is that it’s not worth it.