Reuters – The European Medicines Agency (EMA) announced Novo Nordisk Diabetes after Icelandic health regulators reported three cases of suicidal or self-harm thoughts in patients taking the drug. The drug Ozempic and the weight loss drug Saxenda are being investigated.
Shares of the Danish pharmaceutical company fell about 1.5% on Monday following the news.
The EMA safety committee is investigating adverse events brought by the Icelandic Medicines Agency, including two cases of suicidal ideation that may be linked to Ozempic and Saxenda, the regulator said.
One Saxenda patient also reported thoughts of self-harm, the agency said.
The EMA investigation is focused on drugs containing the active ingredients semaglutide or liraglutide for weight loss.
The review comes after regulators warned of the thyroid cancer safety of several Novo products, including the active ingredient semaglutide, which is used in the diabetes drug Ozempic and the obesity drug Wegobee, which is in high demand in the United States. It happened a few weeks later. Saxenda contains liraglutide.
Currently, suicidal ideation is not listed as a side effect in the EU product information for these treatments.
Side effects have hampered some previous attempts by the pharmaceutical industry to develop profitable weight loss drugs.
Sanofi’s Acomplia failed to gain approval in the United States, but was withdrawn from Europe in 2008 after it was linked to suicidal ideation.
Acomplia was designed to alter the part of the nervous system that regulates appetite. However, newer weight-loss drugs such as Wegovy regulate appetite by mimicking gut hormones and do not directly interfere with brain chemistry.
The EMA said Monday it would consider whether to expand its review to include other drugs in the same class known as GLP-1 receptor agonists.
Novo Nordisk said patient safety is a top priority and the company takes all reports of adverse events very seriously.
Safety data did not show any “causal link” between suicidal ideation or self-harm and drugs, he added.
(Reporting by Bambi Satya, Bangalore and Ludwig Berger, Frankfurt; Editing by Savio D’Souza, Nivedita Bhattacharjee, Sriraj Karvilla)
