EU health officials investigate weight loss drugs after reports of suicidal thoughts
Review comes after reports that some patients had reported suicidal or self-injury thoughts after using Ozempic and Saxenda
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European Union health officials are looking into possible adverse effects of certain popular weight loss drugs such as Novo Nordisk's Ozempic and Saxenda after reports of people having suicidal thoughts.
The European Medicines Agency (EMA), which is in charge of the evaluation and supervision of pharmaceutical products in the EU, told FOX Business that its safety committee is currently evaluating the risk of thoughts of suicide and self-harm in patients who used a semaglutide- or liraglutide-containing medicine for weight loss.
Semaglutide is the medicine sold under the brand names Wegovy and Ozempic. Liraglutide is the medicine sold under the name Saxenda. All the drugs are manufactured by Danish drugmaker Novo Nordisk.
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The EMA said the review was initiated after the Icelandic Medicines Agency flagged three cases where patients had reported thoughts of suicide or self-injury following the use of Saxenda and Ozempic.
Ozempic is made by Danish pharmaceutical company Novo Nordisk. (Joel Saget/AFP via / Getty Images)
The EMA said its safety committee "will consider whether the review should be extended to also include other medicines of the same class."
"Suicidal behaviour is not currently listed as a side effect in the EU product information of these medicines," the EMA said.
In the U.S., though, the "FDA requires medications for chronic weight management that work on the central nervous system, including Wegovy and Saxenda, to carry a warning about suicidal behavior and ideation," Novo Nordisk told FOX Business, adding that "this event had been reported in clinical trials with other weight management products."
Novo Nordisk said it "remains confident in the benefit risk profile of the products" but that it takes "reports about adverse events from use of our medicines very seriously."
The company noted that the GLP-1 receptor agonists "have been used to treat type 2 diabetes for more than 15 years and for treatment of obesity for 8 years." This includes Wegovy and Saxenda, which have been on the market for more than 10 years, Novo Nordisk continued.
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The U.S. Food and Drug Administration (FDA) approved Ozempic in 2017 and it is marketed for medical use in the treatment of Type 2 diabetes "with weight loss as a secondary effect of the drug’s effects and mechanism of action."
The Food and Drug Administration headquarters on July 20, 2020, in White Oak, Maryland. (Sarah Silbiger / Getty Images)
Wegovy was approved four years later, specifically for chronic weight management in adults who are obese or overweight and have at least one weight-related condition such as high blood pressure, Type 2 diabetes or high cholesterol, according to the FDA.
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Both have surged in demand in the U.S. after celebrities and high-profile figures boosted their impact as a weight loss treatment.
Saxenda has been approved since 2014 for chronic weight management, alongside a good diet and exercise, in adults with a certain BMI who have at least one weight-related condition. In 2020, federal health officials in the U.S. extended this approval to cover patients aged 12 and older who are obese.
Novo Nordisk says it's "continuously performing surveillance of the data from ongoing clinical trials and real-world use of its products and collaborates closely with the authorities to ensure patient safety."