Tuesday, May 30, 2023

There is a shortage of a drug for weight loss and there is concern about the demand for unapproved generics

In the United States, Ozempic, a diabetes drug that is also used to reduce weight, is in short supply, and there has been a surge in generic versions that were not approved, for which regulatory bodies in that country expressed their “concern”. We do.

Amid the frenzy to buy Ozempic, patients are turning to telehealth platforms, medical spas and compounding labs to offer some as a generic version of the drug.

But Novo Nordisk, the company that makes Ozempic, does not sell semaglutide for use in compounding, and there is no FDA-approved generic form of the drug.

Certain compounds that cause concern

According to the American Pharmacists Association, there are approximately 7,500 compounding pharmacies in the United States. Magistral formulations involve mixing and modifying drugs and preparing them individually for patients based on their specific needs; For example, someone who is allergic to a certain ingredient of a drug may need a reformulated version.

Since Ozempic is classified as “currently in short supply” by the FDA’s drug shortage website, compounding pharmacies are permitted to purchase semaglutide from pharmaceutical ingredient manufacturers and prepare it as an injectable drug that they can dispense. distribute.

It’s often combined with a B vitamin or a metabolic compound called L-carnitine, which some research suggests may help with weight loss. Some compounding pharmacies are dispensing a completely different active ingredient: Semaglutide Sodium, the sodium salt form of Semaglutide.

In recent weeks, regulators have expressed “concerns” about semaglutide sodium, which is being sold as a research chemical. It appears to fall short of federal law standards for preparing the compound, as the compound is not listed as an FDA-approved drug and officials have expressed alarm over its widespread use.

The FDA does not veto compound formulations and does not evaluate, approve, or test (for efficacy and safety) semaglutide drugs offered by compounded formulation pharmacies. According to an agency representative, semaglutide in compounded formulations, like any other finished drug, has a “high risk” to patients.

Nation World News Desk
Nation World News Deskhttps://nationworldnews.com/
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