(Provides particulars and background all through)
Dec 21 (Reuters) – The U.S. Meals and Drug Administration on Thursday warned customers to not use counterfeit variations of Novo Nordisk’s diabetes drug Ozempic which were discovered within the nation’s drug provide chain.
The well being regulator stated it would proceed to research counterfeit Ozempic 1 milligram injections and has seized 1000’s of models, however flagged that some should be out there for buy.
Danish drugmaker Novo Nordisk and the FDA are testing the seized merchandise and don’t but have details about the medicine’ id, high quality or security, the company stated.
Novo stated the seizures befell in warehouses outdoors the corporate’s licensed provide chain.
The company stated the needles from the seized injections are counterfeit and their sterility can’t be confirmed, which presents an extra threat of an infection for sufferers.
Different confirmed counterfeit parts from the seized merchandise embrace the pen label and accompanying details about the healthcare skilled and affected person in addition to the carton.
The FDA urged drug distributors, retail pharmacies, healthcare practitioners and sufferers to examine the drug they’ve acquired and to not distribute, use or promote the models labeled with lot quantity NAR0074 and serial quantity 430834149057.
The regulator stated it was conscious of 5 hostile occasions ensuing from use of the drug belonging to this lot, however all of them had been in keeping with recognized side-effects associated to genuine Ozempic.
Demand for Wegovy and Ozempic is exceeding Novo’s provide of the medicine in the USA, Germany and Britain, main the corporate to limit provides of sure doses of Wegovy to the U.S. market.
Although solely Wegovy is accepted for weight problems, its diabetes counterpart Ozempic additionally results in dramatic weight reduction, which has led folks in the USA and Europe to make use of the drug “off-label”, that means not for its accepted use.
(Reporting by Sriparna Roy and Bhanvi Satija in Bengaluru; Modifying by Shounak Dasgupta and Krishna Chandra Eluri)
