UK Probes Weight Loss, Diabetes Drugs for Suicidal Ideation and Self-Harm Risk
26 Jul 2023
Drug Approval
Pictured: A silhouette of a woman sitting on the floor with her head in her hands/iStock, simpson33
The UK’s Medicines and Healthcare products Regulatory Agency said Wednesday that it is reviewing a class of drugs used for obesity and diabetes treatment after reports of self-injury and suicidal thoughts in patients.
The probe by the MHRA comes shortly after the European Medicines Agency (EMA) expanded its own investigation into the GLP-1 receptor agonistGLP-1 receptor agonist class of drugs. This includes medications like Saxenda (liraglutide), Wegovy (semaglutide) and Ozempic (semaglutide) produced by Danish pharma company Novo Nordisk. According to reporting by Reuters, the MHRA also confirmed AstraZeneca’s Bydureon (exenatide), Sanofi’s lixisenatide, and Eli Lilly’s dulaglutide were also being included in the review.
Novo Nordisk told Reuters that it had received a request from the MHRA about the investigation. “The review is ongoing and a response will be provided within the requested timelines,” Novo Nordisk said in a statement.
The MHRA review kicked off July 12, though the agency could not specify when it would conclude. The agency received five reports of suspected adverse reactions involving suicidal and self-injury behaviors for patients taking semaglutide between 2020 and July 6 of this year. Over the same timeframe, the regulator received 12 reports of suspected adverse reactions involving thoughts of suicide and self-harm behavior for patients taking liraglutide.
The drugs work by suppressing appetite and encouraging insulin release from the pancreas, making them useful as treatments for weight loss as well as helping patients manage Type 2 diabetes.
Wegovy was approved in the UK in 2021 for weight-loss treatment, though Novo has held off launching the product, focusing instead on its burgeoning U.S. market. In its statement to Reuters, MHRA added that Ozempic is commonly used off-label for weight loss in the UK, though it hasn’t been approved for such use.
The EMA kicked off its own investigation on July 3, focusing on Ozempic, Saxenda, and Wegovy, after receiving 150 reports of possible cases of self-injury or suicidal thoughts among patients taking semaglutide or liraglutide.
“Liraglutide and semaglutide medicines are widely used, with an exposure of over 20 million patient- years to date,” the EMA said in a statement. “It is not yet clear whether the reported cases are linked to the medicines themselves or to the patients’ underlying conditions or other factors.”
Saxenda and Wegovy are approved for weight loss in the EU, and Ozempic is approved for treatment of Type 2 diabetes, though both are paired treatments with diet and exercise. The EMA also noted that Ozempic is used in the EU off-label for weight loss and suicidal behavior is not listed as a side effect for any GLP-1 receptor agonistsGLP-1 receptor agonists approved in the EU.
That European investigation is expected to be completed by November.
Connor Lynch is a freelance writer based in Ottawa, Canada. Reach him at lynchjourno@gmail.com.
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