UK probes Novo Nordisk Ozempic, Saxenda over suicidal, self-harming thoughts

The Medicines and Healthcare products Regulatory Agency (MHRA) said in a statement to Reuters late on Tuesday it was reviewing safety data on a class of drugs known as GLP-1 receptor agonists.

This includes Novo's Ozempic, which contains the active ingredient semaglutide and is approved to treat Type 2 diabetes.

Another drug being reviewed is Novo's Saxenda, which contains the active ingredient liraglutide and is approved as a weight-loss treatment. Saxenda is Novo's older GLP-1 drug and has lower effectiveness than its newer obesity treatment Wegovy, which contains semaglutide.

Novo told Reuters it had received a request on Monday from the MHRA about the agency's review of potential suicidal and self-harming thoughts related to GLP-1 drugs.

"The review is ongoing and a response will be provided within the requested timelines," it said in a statement.

The MHRA said AstraZeneca's GLP-1 drug for type 2 diabetes, called exenatide and marketed as Bydureon, was also included in the review. AstraZeneca did not immediately respond to a request for comment on Wednesday.

The MHRA said two other GLP-1 drugs, Sanofi's lixisenatide and Eli Lilly's dulaglutide, were also included.

Sanofi told Reuters it is aware that the MHRA is conducting the review.

"We are working with the MHRA," it said. "Sanofi confirms our continuous patient safety and pharmacovigilance monitoring system has not identified any safety concerns."

"We are aware of the MHRA’s review," Eli Lilly said in a statement to Reuters. "Patient safety is Lilly’s top priority, and we will respond to the review regarding safety signals related to dulaglutide (Trulicity) as part of our routine regulatory review processes."

GLP-1 receptor agonists were originally developed to treat type 2 diabetes. They mimic a gut hormone that suppresses appetite, promoting a feeling of fullness.

The MHRA told Reuters that its review was initiated on July 12. The agency said it could not specify when it would conclude or what the results might be.

It said the review would consider safety data including adverse drug reactions reported by patients and clinicians to the MHRA and other medicines regulators that it did not name.

Between 2020 and July 6 this year, the MHRA received five reports of suspected adverse drug reactions involving semaglutide associated with "suicidal and self-injurious behaviour", via its Yellow Card scheme for collecting and monitoring safety concerns such as side effects from medicines.

Between 2010 and July 6 this year, the MHRA received 12 suspected adverse drug reactions involving liraglutide also associated with "suicidal and self-injurious behaviour".

"Patient safety is our top priority," said Dr Alison Cave, the agency's chief safety officer. "We will carefully consider all available evidence and communicate any further advice to patients and healthcare professionals as appropriate."

The existence of a report is not proof of causation, the MHRA says.

The agency approved Novo's Wegovy in 2021 for weight-loss treatment, but the drug has not yet launched in Britain. Novo has put off introducing the drug in much of Europe to prioritise supplying the United States, where demand has surged since its launch two years ago.

The weekly injection leads to an average weight loss of around 15%, alongside changes to diet and exercise.

The MHRA said in its statement that though Ozempic was not approved for weight loss, "it is commonly used off-label for that purpose" in Britain.

The European Medicines Agency (EMA) said earlier this month it had begun investigating GLP-1 drugs after Iceland's health regulator flagged three cases of patients thinking about suicide or self-harm.

It is also investigating GLP-1 drugs for possible risk of thyroid cancer.

Read also: Obesity drugs could be added to WHO essential medicines list