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Weight-loss medications from Novo Nordisk A/S are being investigated by the European Union’s drugs regulator after several reports of suicidal risks were referred to the watchdog.
The European Medicines Agency is looking at adverse events noted by the Icelandic Medicines Agency, including two cases of suicidal thoughts linked to the drugs Saxenda and Ozempic, the EMA said in a statement Monday. One additional case relating to thoughts of self-injury has been raised in connection with Saxenda.
The agency is investigating the possible side effects in relation to patients who have used medicines containing the active ingredients semaglutide or liraglutide for weight loss. Novo’s latest hit weight-loss drug Wegovy also contains semaglutide.
Novo has burst into the limelight over the last two years after Wegovy and sister diabetes drug Ozempic were found to induce significant weight loss for people, with celebrities and high profile business personalities openly discussing their use of them. The popularity of the medicines has led to supply shortages and delays in launching the drugs in new markets.
The EMA said it would consider whether its review should be extended to other drugs in the same class, known as GLP-1 receptor agonists.
Novo said in a statement that patient safety is a “top priority” and it takes all reports of adverse events very seriously.
“GLP-1 receptor agonists have been used to treat type 2 diabetes for more than 15 years and for treatment of obesity for eight years, including Novo products such as semaglutide and liraglutide that have been on the market for more than 10 years,” a spokesperson for the company said.
Saxenda, which uses the active ingredient liraglutide, is a weight loss medication that was first approved for use in 2014. Ozempic is approved for use by people with type 2 diabetes and uses the same active ingredient, semaglutide, as Wegovy, which was authorized for use in 2021.
Wegovy is currently available in the US, Denmark and Norway and is set to go on the market in Germany this month. While the drug is not yet sold in the UK, the government announced last month it was looking at making it more widely available than originally planned with a pilot program aimed at expanding weight-loss services.
