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FDA Tracking Hundreds of Reports on Compounded Weight-Loss Drugs and Unapproved Peptides

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The FDA is tracking hundreds of reported problems involving compounded weight-loss medications, WBAY reports, as unapproved peptide products marketed for weight loss, muscle growth and recovery become easier to buy. The agency says some of the reported dosing errors have required hospitalization.

The drugs at the center of this are the GLP-1s, used for diabetes and weight loss, in compounded form. Compounding means a pharmacy makes a medication for a patient with a specific medical need, and compounded drugs are not FDA approved. Peptides, the other category here, are short chains of amino acids that act as messengers in the body.

The numbers so far

As of the end of May, the FDA had received 990 adverse-event reports associated with compounded semaglutide and more than 730 involving compounded tirzepatide. The agency says that does not mean the drug caused every reported problem, and it says the totals may be underreported, which cuts in both directions.

Shabbir Imber Safdar, executive director of Partnerships for Safe Medicines, told WBAY that poison control calls have spiked over the last four years among people misdosing themselves with compounded products. He also pointed to standout individual incidents of harm.

Advertised is not legal

The most useful line in the coverage is Safdar's point that visibility gets mistaken for legitimacy. "What people are being misled by is the idea that because they are being advertised, they must be legal. They're not," he said, naming retatrutide, also called triple G, and products marketed as the Wolverine or the GlowStack as things that are not legal to distribute to Americans.

Some peptides on sale are labeled "research use only" or "not for human consumption." Experts quoted say those should not be treated as approved medications, and that a product being purchasable says nothing about whether it has been shown safe.

What the experts tell people to ask

For a compounded GLP-1, the questions are why that version was prescribed and which pharmacy is making it. The FDA has found fraudulent compounded products listing pharmacies that never made them.

Safdar also flagged the speed of the prescriber. "If you have like an email consultation or like a 30-second conversation or even a chat diagnosis and medical consult, that's not sufficient," he said.

Bottom line

Cost is driving demand, and experts say prices for some approved options have come down. What remains unsettled is how much of the reported harm traces back to the compounded products themselves, and how much of the total the FDA is still not seeing.

Source: RSS.app — Peptides bundle. Read the original.

Filed under: fda, muscle, recovery

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