Advocacy Group for Diabetes Urges Against Compounded GLP-1 Medications
The American Diabetes Association (ADA), an influential advocacy organization, is raising alarms regarding the increasing use of compounded formulations of well-known weight loss and diabetes medications like Wegovy and Zepbound.
On Monday, the ADA issued an official recommendation cautioning healthcare providers against prescribing non-approved, generic alternatives of these medications, which have become so popular that their manufacturers, Novo Nordisk and Eli Lilly, are struggling to maintain adequate supply levels.
“We strongly encourage healthcare professionals to heed this guidance statement, considering the potential safety, quality, and efficacy concerns linked to compounded versions of these medications,” remarked Joshua Neumiller, the ADA’s president-elect and an author of the guidance.
According to the ADA, these compounded drugs may not conform to Food and Drug Administration (FDA) standards concerning drug content, safety, or effectiveness. Compounding pharmacies may have introduced additional ingredients like vitamins B12 and B6 or altered the active ingredients’ salt forms, leading to dosage inaccuracies and adverse reactions, the organization noted.
“We advise both healthcare professionals and individuals living with diabetes or obesity to use this guidance alongside clinical judgment and personal preferences to make informed decisions about their care,” added Nuha ElSayed, the ADA’s senior vice president for health care improvement.
Wegovy comprises semaglutide, which is also marketed as Ozempic for managing Type 2 diabetes by Novo. Similarly, Eli Lilly offers tirzepatide under the brand Mounjaro for diabetes and Zepbound for obesity. Both of these medications are classified as incretin therapies or GLP-1 agonists.
These medications have shown remarkable effectiveness in weight management, and additional research has indicated further health advantages, including reducing cardiovascular risk with Wegovy and assisting in sleep apnea control with Zepbound. The soaring demand has contributed to frequent shortages over the past couple of years, as both Novo and Lilly have faced challenges in producing sufficient doses.
These shortages have led healthcare providers and patients to seek alternatives from compounding pharmacies, which prepare customized formulations of approved drugs under specific FDA regulations.
By releasing this statement, the ADA, which encompasses healthcare professionals, health educators, and community workers, has positioned itself as a significant voice in an ongoing debate involving the FDA and compounding pharmacies.
The FDA currently lists Wegovy and Ozempic as available and officially ended the shortage of Zepbound and Mounjaro in October. This announcement was followed by warnings to compounders that their formulations were subject to legal restrictions once again.
However, the Outsourcing Facilities Association, representing compounding pharmacies, swiftly initiated legal action against the FDA, resulting in the agency retracting its enforcement of the regulations. The FDA has committed to reviewing its decision regarding Zepbound and Mounjaro and has postponed any actions until December 19.
Former FDA commissioner Scott Gottlieb has criticized the FDA for allowing compounded formulations of tirzepatide to continue, claiming they leverage the prices of branded versions to evade compounding regulations set forth in the Drug Quality and Security Act.
In the meantime, Hims and Hers, which markets compounded versions of semaglutide, has been running advertisements in The New York Times concerning the obesity crisis, emphasizing the potential disruptions that could arise if the FDA takes action against compounded GLP-1 medications.