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New warning issued about compounded version of weight loss drugs

Health officials are cautioning patients using the semaglutide medications Ozempic and Wegovy that companies could be creating knockoff versions.

AUSTIN, Texas — The U.S. Food and Drug Administration (FDA) has issued a new warning to patients taking semaglutides Ozempic and Wegovy for Type 2 diabetes or weight loss.

Experts say patients need to be cautious about where they get the medications. Because of drug shortages, some companies are making compounded versions of the drugs, which means they're combining or mixing ingredients. 

Dr. Kajal Shah with Texas Diabetes & Endocrinology said semaglutide medications increase the production of insulin in your body, decreasing appetite and making the food in the stomach stay longer. 

"Because of all these effects, it helps in reducing blood sugars as well as losing weight. And because of these effects, FDA approved these medications under the brand name of Ozempic and Wegovy for the treatment of Type 2 diabetes and for the treatment of obesity," Shah said.

The medications are only available by prescription through a licensed health care provider. Shah said there aren't any generic versions of the drugs available on the market that are FDA-approved. 

"These drugs also are available in different dose strengths, and it requires very careful titration by a health care provider and constant supervision for some of the serious side effects," Shah said.

Before starting a medication, it's recommended that you discuss with a health care provider if you actually qualify for using that medication. Then, after starting the medication, because they work on the hormones in the gut, patients need to watch out for some gastrointestinal-related side effects like nausea, vomiting, diarrhea and feeling run down. 

"There's also some association with pancreatitis risk if they use a lot of alcohol or they have really high cholesterol issues. So a lot of serious side effects need to be discussed and warned about before starting these medications," Shah said.

Shah said the problem with compounded medications is the actual medication may not be authentic and the ingredients compounding pharmacies add to make the compounding version have little transparency about the ingredients. She said patients might be putting themselves at incalculable risk by using these medications.

"The compounding pharmacies have started making compounded versions of these medications, which are not FDA-approved. FDA specifically issued a warning this month regarding these certain salts of semaglutide, which are being sold and manufactured in these pharmacies. So these salts are actually different from the semaglutide, which is present in the FDA-approved versions of these medications. And therefore they have not gone through the rigorous safety trials," Shah said.

She said patients should avoid using these medications in a nontraditional way or as a fast-track approach to weight loss when they don't know what other health risks they're incurring as a part of the process. Also, prescription-based medication should only be prescribed by a certified health care provider. 

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