FDA Says Patients May Be Overdosing on Some Weight Loss Drugs – Journal Important Online

• The bureau said grouping haw be overdosing on knock-off semaglutide weight-loss drugs.
• Consumers are self-administering inaccurate doses.
• Reports institute whatever grouping administered 5 to 20 nowadays more semaglutide than intended.

The US Food and Drug Administration says whatever grouping hit been hospitalized with symptoms that haw be attendant to overdoses from injectable weight-loss drugs.

The authority alerted aid providers and patients on Friday, locution it conventional reports that whatever grouping wanted scrutiny tending or required hospitalisation after attractive inaccurate doses of “compounded” semaglutide products.

Compounded pharmaceuticals are essentially copies of authorised medications that the bureau allows during a insufficiency but which hit not absent finished the customary bureau support process. This is currently the housing for semaglutide, which is oversubscribed low the sort obloquy Ozempic and Wegovy.

Compounded semaglutide is a slightly more Byzantine story, however. The Nordic caregiver consort Novo Nordisk has a papers on the semaglutide mote and doesn’t substance it for understanding for compounding. This has caused fault over where whatever pharmacies are sourcing ingredients.

“Compounded drugs bear a higher venture to patients than FDA-approved drugs because compounded drugs do not participate bureau premarket analyse for safety, calibre or effectiveness,” the signal said.

The diet business has exploded in past eld in conception cod to the FDA’s 2021 selection to okay semaglutide — a take originally witting to impact identify 2 diabetes — for blubber management. Novo Nordisk’s injectable medications, Wegovy and Ozempic, apace gained tending from consumers, modify among those who couldn’t give the precipitous toll tag.

The bureau did not deal the sort of reports it conventional but said the inauspicious upbeat events haw be attendant to inaccurate dosing of compounded semaglutide products.

“Dosing errors hit resulted from patients activity and self-administering inaccurate doses of the take and upbeat tending providers miscalculating doses of the drug,” the bureau said.

The signal additional that whatever patients administered 5 to 20 nowadays more than intended, and digit aid bourgeois formal at small threesome patients 20 units instead of two.

The bureau also said there are no business standards regarding compounded semaglutide since products crapper become in assorted concentrations, containers, syringe sizes, and instructions.

“FDA encourages compounders, upbeat tending providers, and patients to inform inauspicious events and take errors related with compounded semaglutide products to FDA’s MedWatch Adverse Event Reporting program,” the authority said.