In USA is scarce Ozempica diabetes drug that is also used to lose weight, and sparked a boom in generic versions that were not approved, for which reason the regulatory bodies of that country express their “worry”.
In the midst of the shopping frenzy Ozempicpatients are turning to platforms of telehealth, medical spas and compounding laboratories to get what some people offer as generic versions of this drug.
But new nordiskthe company that manufactures Ozempicdoes not sell the semaglutide for the elaboration of master formulas and there is no generic form of the drug approved by the United States Food and Drug Administration (FDA, for its acronym in English).
Some mixtures that cause concern
According to American Pharmacists Associationin USA there are about 7,500 compounding pharmacies. Magistral formulations involve mixing and modifying medications and preparing them individually for patients based on their specific needs; for example, someone who is allergic to a certain ingredient in a drug may need a reformulated version.
As the scarce medicines website of the FDA classifies the Ozempic as “in short supply right now,” compounding pharmacies are allowed to buy the compound from you. semaglutide to pharmaceutical ingredient manufacturers and prepare it as an injectable drug that they distribute.
It is often also mixed with B vitamins or a metabolic compound called L-carnitine, which, according to some research, can help you lose weight. Some compounding pharmacies are distributing an entirely different active ingredient: semaglutide sodiumthe sodium salt form of the semaglutide.
In recent weeks, regulators have expressed “concern” about the semaglutide sodium, which is eventually sold as a research chemical. It does not appear to meet federal law standards for compounding, in part, because this substance is not listed as a drug approved by the FDA and the authorities expressed alarm at its widespread use.
The FDA does not veto compounded formulations and has not evaluated, approved, or tested (with respect to efficacy and safety) medicines from semaglutide offered by magisterial formula pharmacies. According to an agency representative, the semaglutide of the magistral formulas has “a higher risk” for patients, just like any other prepared medicine.
Source: Ambito
