TGA confirms surveillance of Novo Nordisk medicines for risk of suicidal thoughts

Pharma News: The Therapeutic Goods Administration (TGA) has responded to investigations into the potential risk of suicidal thoughts and self-injury among patients taking obesity and diabetes medicines manufactured by Novo Nordisk.

The European Medicines Agency’s (EMA) investigation has expanded to encompass Novo Nordisk’s Ozempic, Wegovy, and Saxenda drugs, along with other weight loss and diabetes medications. The decision came after Iceland’s health regulator also raised concerns over patients experiencing thoughts of suicide or self-harm while on these medications.

Liraglutide, the active ingredient of Novo Nordisk’s weight loss drug Saxenda, and semaglutide, found in their weight loss injection Wegovy and diabetes counterpart Ozempic, belong to a class of drugs known as GLP-1 receptor agonists.

A spokesperson from the TGA told Health Industry Hub, “We are currently aware of ongoing investigations into potential psychological reactions related to semaglutide and liraglutide. While we cannot confirm these as safety issues at this point, the TGA is closely monitoring all available evidence, including adverse event reports, medical literature, and discussions with international regulators. If any safety issues are confirmed, prompt regulatory actions will be taken as necessary.”

TGA’s Database of Adverse Event Notifications (DAEN) revealed relevant data for Saxenda (Liraglutide) and Ozempic/Wegovy (Semaglutide) between certain time periods. For Saxenda, there were 39 reported cases of psychiatric disorders, including 19 instances of suicidal ideation, which accounted for 8.2% of all adverse events reported for this drug between April 2017 and June 2023. Meanwhile, Ozempic and Wegovy showed 17 reported cases of psychiatric disorders, with four cases of suicidal ideation, making up 4.9% of all adverse events reported for these drugs between October 2020 and May 2023.

In response to the investigations, Novo Nordisk issued a statement emphasising that safety data from large clinical trials and post-marketing surveillance have not indicated a causal association between semaglutide or liraglutide and suicidal or self-harming thoughts.

Interestingly, individuals with a history of psychiatric disorders or recent suicidal behaviour were excluded from clinical trials for Ozempic and Saxenda. While Wegovy’s trials did not suggest an increased risk of suicidal behaviour, the drug’s label contains a warning for suicidal behaviour and ideation.

Novo Nordisk reaffirmed its commitment to patient safety and assured that it continuously monitors data from ongoing clinical trials and real-world use of its products.

As the investigations progress, it is likely that the outcome will involve a change in the drug labels to include a warning about the potential side effect of suicidal ideation.

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