The review of the safety data was triggered following reports of suicidal thoughts and self-injury in people using Ozempic and Saxenda drugs, Reuters reported
A image of semaglutide in a tablet. (Credit: Novo Nordisk A/S)
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has started a probe into the use of Novo Nordisk’s Ozempic (semaglutide) and Saxenda (liraglutide) drug over suicidal and self-harming ideation.
Ozempic and Saxenda, a class of drugs known as GLP-1 receptor agonists, are indicated for the treatment of treating type 2 diabetes (T2D) and as a weight-loss treatment respectively.
The review of the safety data was triggered following reports of suicidal thoughts and self-injury in people using Ozempic and Saxenda drugs, Reuters reported.
The probe follows the recently announced investigation of the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) over the risk of suicidal and self-harming thoughts associated with the use of Ozempic, Saxenda and Wegovy (semaglutide).
According to EMA, suicidal behaviour is not currently registered as a side effect in the EU product information for any of the GLP-1 receptor agonists.
Wegovy is Novo’s latest weight-loss treatment that is said to be more effective than Saxenda.
Novo informed Reuters that it had received a request from the MHRA on Monday regarding the agency’s investigation of the drugs.
The Danish pharmaceutical company was quoted by the news agency as saying: “The review is ongoing and a response will be provided within the requested timelines.”
The MHRA review also includes AstraZeneca’s GLP-1 drug for type 2 diabetes, dubbed Bydureon (exenatide), Sanofi’s lixisenatide and Eli Lilly’s dulaglutide.
To Reuters, Sanofi said: “We are working with the MHRA. Sanofi confirms our continuous patient safety and pharmacovigilance monitoring system has not identified any safety concerns.”
According to the news agency, the MHRA’s review was started on July 12. The agency stated that it was unable to provide an estimated completion date or potential outcomes.
It stated that safety information, such as adverse medication responses recorded by patients and physicians to the MHRA and other medicine regulators it did not identify, will be taken into consideration.
MHRA chief safety officer Alison Cave said: “Patient safety is our top priority. We will carefully consider all available evidence and communicate any further advice to patients and healthcare professionals as appropriate.”