US regulators are monitoring international probes into patient reports of suicidal thoughts that may be associated with a new class of drugs from Novo Nordisk and Eli Lilly Co. used for diabetes treatment and weight loss.
(Bloomberg) — US regulators are monitoring international probes into patient reports of suicidal thoughts that may be associated with a new class of drugs from Novo Nordisk and Eli Lilly Co. used for diabetes treatment and weight loss.
Earlier this month, the UK Medicines & Healthcare Products Regulatory Agency received several reports of suspected adverse drug reactions associated with semaglutide — the active ingredient in Novo’s diabetes and weight-loss drugs Ozempic and Wegovy. The agency, known as MHRA, also received reports linked to liraglutide — the active ingredient in Saxenda.
The reports sparked an investigation into all so-called GLP-1 drugs available in the UK, including Sanofi’s lixisenatide, Eli Lilly’s dulaglutide, and a diabetes drug from AstraZeneca Plc, which uses the active ingredient exenatide.
The European Medicines Agency is also investigating suicide-related risks after receiving reports from the Icelandic Medicines Agency related to Saxenda and Ozempic.
The US Food and Drug Administration hasn’t launched its own investigation, but “regularly communicates with other regulatory agencies and is aware of these developments,” an FDA spokesperson confirmed in an email Thursday.
Suicidal behavior is not currently listed as a side effect in the EU product information of the drugs. However, in the US, the labels for Wegovy and Saxenda already include warnings for suicidal behavior and thoughts and recommend that patients using these drugs are monitored for worsening symptoms. Clinical trial data in the US did not support warnings for suicidal thoughts or behavior for the GLP-1s approved for diabetes indications.
The FDA routinely evaluates adverse event reports, the agency spokesperson said, and continues to monitor the safety of all approved products, including suicidal behavior and ideation associated with the use of GLP-1s.
“[The FDA] will inform the public and take regulatory action to protect the public health if appropriate, the agency said. “We continue to conclude that the benefits of these medications outweigh their risks when they are used according to the FDA-approved labeling.”
–With assistance from Madison Muller.
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