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FDA Issues Warning About Compounded Diabetes Drug Semaglutide Products

by Dr. Jayashree Gopinath on Jun 5 2023 11:23 PM
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 FDA Issues Warning About Compounded Diabetes Drug Semaglutide Products
The U.S. Food and Drug Administration issued a warning on 30th May about compounded versions of the drug semaglutide, which is approved for the treatment of diabetes and excess weight.
Semaglutide, a type of drug called a GLP-1 agonist, is FDA-approved as Ozempic and Rybelsus to treat type 2 diabetes and as Wegovy to treat overweight and obesity. Ozempic and Wegovy have been on the FDA's Drug Shortages list since last year.

Semaglutide belongs to a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. It mimics the GLP-1 hormone that is released in the gastrointestinal tract in response to eating (1 Trusted Source
Semaglutide for the treatment of obesity

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).

One role of GLP-1 is to prompt the body to produce more insulin, which reduces blood glucose (sugar). GLP-1 in higher amounts also interacts with the parts of the brain that reduce appetite and signal a feeling of fullness.

Ozempic injection and Rybelsus tablets are approved to lower blood sugar levels in adults with type 2 diabetes mellitus, in addition to diet and exercise. Ozempic is also approved to reduce the risk of heart attack, stroke, or death in adults with type 2 diabetes mellitus and known heart disease.

Wegovy injection is approved to help adults and children aged 12 years and older with obesity or some adults with excess weight (overweight). All three medications are only available with a prescription, and there are no approved generic versions.

Safety Concerns Over Some Compounded Versions of Semaglutide for Diabetes, Weight Loss

When a drug is in shortage, compounders may be able to prepare a compounded version of that drug if they meet certain requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act. But the agency does not review these compounded versions for safety, effectiveness, or quality.

Compounding "is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Compounding includes the combining of two or more drugs.

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The FDA has received reports of adverse events in people who used compounded semaglutide. Patients and healthcare professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality (2 Trusted Source
Pharmaceutical Compounding: a History, Regulatory Overview, and Systematic Review of Compounding Errors

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).

Additionally, FDA has received reports that in some cases, compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate. The salt forms are different active ingredients than is used in the approved drugs, which contain the base form of semaglutide.

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The agency is not aware of any basis for compounding using the salt forms that would meet the FD&C requirements for types of active ingredients that can be compounded. On April 27, 2023, FDA wrote to the National Association of Boards of Pharmacy expressing the agency’s concerns with use of the salt forms in compounded products.

What Should Patients Know?

Patients should be aware that some products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products and maybe salt formulations. Products containing these salts, such as semaglutide sodium and semaglutide acetate, are not safe and effective.

Patients should only obtain drugs containing semaglutide with a prescription from a licensed health care provider, and only obtain medicines from state-licensed pharmacies or outsourcing facilities registered with FDA.

Purchasing medicine online from unregulated, unlicensed sources can expose patients to potentially unsafe products that have not undergone appropriate evaluation or approval, or do not meet quality standards. If you choose to use an online pharmacy, look for more informed decisions when purchasing prescription medicine online.

Healthcare professionals who are considering working with compounders to obtain semaglutide products should be aware that compounders may be using salt forms of semaglutide.

References:
  1. Semaglutide for the treatment of obesity - (https://www.sciencedirect.com/science/article/abs/pii/S1050173821001584)
  2. Pharmaceutical Compounding: a History, Regulatory Overview, and Systematic Review of Compounding Errors - (https://link.springer.com/article/10.1007/s13181-020-00814-3)


Source-Medindia


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