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(Reuters) -The U.S. Meals and Drug Administration on Friday warned sufferers and medical doctors about dosing errors related to compounded variations of Novo Nordisk (NYSE:)’s weight-loss and diabetes medication.
The well being regulator stated it had obtained experiences of adversarial occasions, some requiring hospitalization, that could be associated to overdoses as a consequence of sufferers incorrectly self-administering the compounded drug and healthcare suppliers miscalculating doses.
The FDA flagged the upper danger to sufferers from using compounded medication, which can include further components, and will contribute to potential treatment errors. It urged healthcare suppliers and compounders to supply the suitable syringe measurement and counsel sufferers on find out how to measure the dose.
Overdoses with these medication may trigger adversarial results together with extreme nausea, vomiting and low blood sugar ranges.
The explosive demand has created an enormous scarcity and fueled a booming world marketplace for cheaper variations, typically even counterfeits.
The FDA has additionally expressed critical considerations in regards to the prevalence of faux variations of Novo’s diabetes drug Ozempic and different medication accredited for weight reduction, together with Novo’s Wegovy and Eli Lilly (NYSE:)’s Zepbound.
Semaglutide, the important thing ingredient in Wegovy and Ozempic, belongs to the GLP-1 class of medication, which work by serving to management blood sugar ranges and triggering a sense of fullness.
Novo’s Wegovy is out there as single-dose pre-filled pens that ship a preset dose for as soon as weekly dosing, whereas Ozempic is out there as multiple-dose pre-filled pens for single-patient use, designed for once-weekly dosing.
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