Diabetes and Obesity Treatment at Risk:  FDA’s Warning on Semaglutide’s Impact in Treatment”

Doctors primarily use semaglutide as a key drug for the treatment of obesity and diabetes. However, in a noteworthy development. FDA issued a warning on Tuesday specifically regarding the compounded version of the drug semaglutide.

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

FDA’s Warning:

The FDA approves semaglutide, a GLP-1 agonist, under the brand names Ozempic and Rybelsus for the treatment of type 2 diabetes, and as Wegovy for the treatment of obesity. The two drugs Wegovy and Ozempic have been in shortage since last year by the FDA list.

If a  drug is in shortage the compounders have the authority to prepare the compounded version of the drug. If the needed requirements of the federal Food, drug, and cosmetic act are met. However, it is important to note that the agency does not approve these compounded versions of semaglutide for quality, safety, and effectiveness.

The FDA confirms that they received reports of undesirable events in patients who consumed compounded semaglutide. And that patients “should not use a compounded drug if an approved drug is available.”

Compounders might be using a medication, such as semaglutide acetate and semaglutide sodium, which contains various ingredients from that of the approved drugs. The agency has no idea about using salt forms that meet the FD&C requirements. Research has demonstrated that semaglutide acetate and semaglutide sodium salts are not deemed safe for consumption.

Patient Safety and Regulations:

FDA confirms that healthcare providers and patients should have a good understanding of the variation of these compounded medicines.

Patients must ensure that they purchase drugs containing semaglutide only after receiving a prescription from a licensed healthcare provider. They must buy it from a state-licensed pharmacy or outsourcing facilities registered with the FDA.

The Alliance for Pharmacy Compounding issued a statement recently. They have mentioned not buying any sort of medicine with semaglutide compounds online. without a prescription and if unable to verify if the seller is a licensed pharmacy in the US. 

Due to its mixture with other ingredients, compounded semaglutide can potentially induce harmful effects. As a consequence, it becomes essential to be cautious and mindful of the potential risks associated with its usage.

Therefore, it is crucial to understand the use of medications that contain semaglutide. After getting a proper analysis from a pharmacist or a result from any lab report.

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