UK Investigating Novo’s Ozempic and Saxenda for Suicidal and Self-Harm Ideas

LONDON (Reuters) – Britain is conducting a review of a category of drugs used in a diabetes medication and a weight-loss treatment produced by Novo Nordisk, following reports of suicidal or self-harming thoughts from some patients. This action comes two weeks after a similar review was initiated by the European Union.

The Medicines and Healthcare products Regulatory Agency (MHRA) announced on Tuesday that it is assessing the safety data on a class of drugs known as GLP-1 receptor agonists. Included in this review is Novo’s Ozempic, which is used for the treatment of Type 2 diabetes and contains the active ingredient semaglutide. The review also covers Novo’s Saxenda, which is approved as a weight-loss treatment, containing the active ingredient liraglutide. Saxenda, an older GLP-1 drug, has lower effectiveness compared to Novo’s newer obesity treatment Wegovy, which contains semaglutide.

Novo confirmed that they received a request from the MHRA on Monday regarding the agency’s review of potential suicidal and self-harming thoughts associated with GLP-1 drugs. In a statement, Novo mentioned that the review is ongoing and they will respond within the requested timelines.

The MHRA stated that AstraZeneca’s GLP-1 drug for type 2 diabetes, Bydureon, which is marketed as exenatide, is also being reviewed. AstraZeneca has not yet responded to the request for comment. Sanofi’s lixisenatide and Eli Lilly’s dulaglutide, two other GLP-1 drugs, are also included in the review. As of now, Sanofi and Lilly have not provided any comments regarding the review.

Originally developed for the treatment of type 2 diabetes, GLP-1 receptor agonists mimic a gut hormone that suppresses appetite and promotes the feeling of fullness.

The MHRA informed Reuters that the review was initiated on July 12 and mentioned that the agency cannot provide a specific timeline for its conclusion or predict the potential results. The review will consider safety data, including reports of adverse drug reactions submitted by patients and clinicians to the MHRA.

Between 2020 and July 6, 2023, the MHRA recorded five reports of suspected adverse drug reactions involving semaglutide associated with “suicidal and self-injurious behavior” through its Yellow Card scheme. Within the same period, the MHRA received 12 suspected adverse drug reactions involving liraglutide associated with similar behavior.

Dr. Alison Cave, the MHRA’s chief safety officer, emphasized that patient safety is their top priority. The agency will carefully consider all available evidence and communicate any appropriate advice to patients and healthcare professionals.

In 2021, Wegovy was approved by the MHRA, but the drug has not yet been launched in Britain. Novo has prioritized supplying the United States, where there has been high demand since the drug’s launch two years ago. The weekly injection of Wegovy leads to an average weight loss of around 15%, in addition to dietary and exercise modifications.

The MHRA noted that although Ozempic is not approved for weight loss, it is commonly used off-label for that purpose in Britain.

The European Medicines Agency (EMA) also initiated an investigation into GLP-1 drugs after Iceland’s health regulator reported three cases of patients experiencing suicidal or self-harming thoughts. The EMA is additionally investigating GLP-1 drugs for potential risk of thyroid cancer.

(Reporting by Maggie Fick; Editing by Josephine Mason and Mark Potter)