European Union well being officers are trying into doable hostile results of sure fashionable weight reduction medicine comparable to Novo Nordisk’s Ozempic and Saxenda after experiences of individuals having suicidal ideas.
The European Medicines Company (EMA), which is accountable for the analysis and supervision of pharmaceutical merchandise within the EU, instructed FOX Enterprise that its security committee is at present evaluating the chance of ideas of suicide and self-harm in sufferers who used a semaglutide- or liraglutide-containing drugs for weight reduction.
Semaglutide is the drugs bought beneath the model names Wegovy and Ozempic. Liraglutide is the drugs bought beneath the title Saxenda. All of the medicine are manufactured by Danish drugmaker Novo Nordisk.
WEGOVY, OZEMPIC: THE BARRIERS TO ACCESSING THESE WEIGHT LOSS DRUGS
The EMA stated the evaluation was initiated after the Icelandic Medicines Company flagged three instances the place sufferers had reported ideas of suicide or self-injury following using Saxenda and Ozempic.
The EMA stated its security committee “will think about whether or not the evaluation must be prolonged to additionally embrace different medicines of the identical class.”
“Suicidal behaviour shouldn’t be at present listed as a aspect impact within the EU product info of those medicines,” the EMA stated.
Within the U.S., although, the “FDA requires medicines for persistent weight administration that work on the central nervous system, together with Wegovy and Saxenda, to hold a warning about suicidal habits and ideation,” Novo Nordisk instructed FOX Enterprise, including that “this occasion had been reported in scientific trials with different weight administration merchandise.”
Novo Nordisk stated it “stays assured within the profit threat profile of the merchandise” however that it takes “experiences about hostile occasions from use of our medicines very critically.”
The corporate famous that the GLP-1 receptor agonists “have been used to deal with sort 2 diabetes for greater than 15 years and for remedy of weight problems for 8 years.” This consists of Wegovy and Saxenda, which have been available on the market for greater than 10 years, Novo Nordisk continued.
PATIENTS STOP WEGOVY, OTHER WEIGHT LOSS-RELATED DRUGS SHORTLY AFTER STARTING, DOCTORS SAY
The U.S. Meals and Drug Administration (FDA) accepted Ozempic in 2017 and it’s marketed for medical use within the remedy of Sort 2 diabetes “with weight reduction as a secondary impact of the drug’s results and mechanism of motion.”
Wegovy was accepted 4 years later, particularly for persistent weight administration in adults who’re overweight or chubby and have at the least one weight-related situation comparable to hypertension, Sort 2 diabetes or excessive ldl cholesterol, in response to the FDA.
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Each have surged in demand within the U.S. after celebrities and high-profile figures boosted their affect as a weight reduction remedy.
Saxenda has been accepted since 2014 for persistent weight administration, alongside an excellent weight loss plan and train, in adults with a sure BMI who’ve at the least one weight-related situation. In 2020, federal well being officers within the U.S. prolonged this approval to cowl sufferers aged 12 and older who’re overweight.
Novo Nordisk says it is “repeatedly performing surveillance of the information from ongoing scientific trials and real-world use of its merchandise and collaborates intently with the authorities to make sure affected person security.”