The EU’s health watchdog is investigating Danish company Novo Nordisk over reported side effects from its products
The European Medicines Agency (EMA) is reviewing several weight-loss jabs for reported risks of inducing suicidal thoughts and self-harm among users. A potential problem with the drugs was first flagged by Iceland’s health watchdog, which reported at least three cases of such behavior.
The issue is reportedly connected with multiple jabs containing liraglutide which is produced by Danish pharmaceutical company Novo Nordisk, namely Wegovy and Saxenda, as well as a similar Ozempic type 2 diabetes jab. The matter is being reviewed by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC).
While the probe focuses on only on compounds that contain liraglutide, it may end up being expanded to other similar treatments in the same category of drugs, an EMA official told British state broadcaster BBC on Monday.
“The review is being carried out in the context of a signal procedure raised by the Icelandic Medicines Agency, following three case reports,” the official said.
“The case reports included two cases of suicidal thoughts – one following the use of Saxenda and one after Ozempic. One additional case reported thoughts of self-injury with Saxenda,” the official said.
All of the prescription drugs under review already carry warnings of a sizeable number of potential side effects, including vomiting, tiredness, diarrhea and constipation, among others. Depression and suicidal thoughts are also listed.
The manufacturer has acknowledged the EMA probe, stating that the company takes “all reports about adverse events from use of our medicines very seriously” and that patient safety remains its “top priority.”
“EMA continuously monitors for safety signals and so does Novo Nordisk. Novo Nordisk remains committed to ensuring patient safety,” a company spokesperson said.
The development has apparently already left a dent on Novo Nordisk’s market value, with shares of the Danish company falling some 1% on Monday after the news broke.