The Medicines and Healthcare Products Regulatory Agency (MHRA), the U.K.'s drug regulatory authority, is reportedly scrutinizing a category of drugs used in diabetes medication and a weight loss product sold by Novo Nordisk A/S (NYSE: NVO).
Ozempic and Wegovy have reportedly caused stomach paralysis in some users. Wegovy and Saxenda have made it to the FDA's list of drugs facing a supply crunch.
The agency is examining the safety data of Ozempic (semaglutide) and Saxenda (liraglutide), medications for Type 2 diabetes and weight loss, respectively.
In addition to Novo's drugs, AstraZeneca Plc's (NYSE: AZN) type 2 diabetes medication Bydureon (exenatide), Sanofi SA's (NASDAQ: SNY) lixisenatide, and Eli Lilly And Co's (NYSE: LLY) dulaglutide are also included in the MHRA's review.
The agency told Reuters the move follows reports of suicidal or self-harming tendencies from some patients two weeks after the European Union initiated a similar review.
Between 2020 and July 6, 2023, the MHRA received five reports of suspected adverse drug reactions involving semaglutide associated with "suicidal and self-injurious behavior" via its Yellow Card scheme for collecting and monitoring safety concerns such as side effects from medicines.
The MHRA also clarified that while Ozempic is not officially approved for weight loss, it is often used "off-label" for that purpose in the UK.
Novo Nordisk told Reuters they received the MHRA's request and would respond within the designated timeframe.
The EU's drugs watchdog, the European Medicines Agency, recently raised a thyroid cancer safety signal for Novo Nordisk's drugs, including the much talked semaglutide used in Ozempic and Wegovy for weight loss.
Price Action: NVO shares are down 3.04% at $157.37 on the last check Wednesday.