OR WAIT null SECS
The ongoing shortage of GLP-1 receptor agonists, namely semaglutide, has prompted the US Food and Drug Administration to issue a warning to patients and providers related to use of compounded semaglutide.
The rapid ascent of the class into the public spotlight as an obesity medication, combined with the strain of the COVID-19 pandemic, has created a historic shortage of multiple GLP-1 receptor agonists.
As of June 7, 2023, dulaglutide (Trulicity), semaglutide injection (Ozempic), and semaglutide injection (Wegovy) were all listed as being currently in shortage according to the US Food and Drug Administration (FDA) Drug Shortages list. Still, the desire for the agents has been so great, the FDA has also released a warning to address use of unapproved, compounded medications containing semaglutide.1,2
“Health care professionals who are considering working with compounders to obtain semaglutide products should be aware that compounders may be using salt forms of semaglutide. FDA is not aware of any basis for compounding a drug using semaglutide salts that would meet federal requirements,” reads the FDA warning.2
The FDA describes drug compounding as “process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient”. The FDA points out the agency does allow for cofounder to prepare compounded version of drugs in shortage if they meet certain requirements in the Federal Food, Drug, and Cosmetic Act.2
According to the FDA Drug Shortages webpage, the shortage of Wegovy began in March 2022 while the shortage of dulaglutide (Trulicity) was first posted in December 2022.The FDA also urged patients to only obtain medicines from state-licensed pharmacies or outsourcing facilities registered with FDA.1
In an update posted on May 04, 2023, Novo Nordisk noted only being able to supply limited quantities of 0.25 mg, 0.5 mg, and 1 mg dose strengths to wholesalers for distribution to retail pharmacies, which will result in many patients having difficult filling prescriptions at those doses through September. In an attempt to quell further demand, the company announced it would be pausing promotional efforts and had plans to work with wholesalers to create a steadier level of inventory.3
In their statement on semaglutide compounding, the FDA called attention to compounding performed with use of salt forms of semaglutide, which the agency indicates does not meet the FD&C requirements for types of active ingredients that can be compounded. The agency directed readers to an April 2023 letter to the National Association of Boards of Pharmacy expressing concerns over use of the salt forms in compounded products.2
“Patients should be aware that some products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products and may be the salt formulations. Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective," warned the FDA.2
When asked, HCPLive Endocrinology advisory board member Diana Isaacs, PharmD, expressed concern over the potential threat posed by the safety of compounded agents.
“The high cost of GLP-1 agonists and recent shortages have created a market for compounded GLP-1s. But these products do not have clinical trials and FDA oversight to guarantee safety and efficacy,” said Isaacs, an endocrine clinical pharmacist and coordinator of the Remote Monitoring Program at the Cleveland Clinic. “I worry about safety since there are reports of alternative semaglutide salts being used with no guarantee it acts the same way as Ozempic and Wegovy. There are also no assurances that compounded semaglutide has enough of the active ingredient to have an effect, and it’s unknown how adding additional ingredients like vitamin B12 affects the molecule.”
The FDA encouraged health care professionals, patients, and compounders to report adverse events or quality problems with semaglutide or any medications to the agency’s MedWatch Adverse Event Reporting program.