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TUESDAY, July 11, 2023 (HealthDay Information) — The European Medicines Company is investigating considerations that well-liked weight-loss medicine like Ozempic and Saxenda could also be linked to suicidal ideas and ideas of self-harm.
Three case experiences from Iceland spurred the company’s security committee to conduct a drugs overview, CNN reported Monday. The EMA is Europe’s equal of the U.S. Meals and Drug Administration.
The Icelandic Medicines Company reported two instances of suicidal ideas. One occurred after use of Ozempic (semaglutide) and the opposite after taking Saxenda (liraglutide). The third report was about Saxenda and ideas of self-injury.
Each medicine are made by Novo Nordisk. The corporate mentioned, “affected person security is a prime precedence,” including it takes “all experiences about antagonistic occasions from use of our medicines very severely,” CNN reported.
Prescribing info in the USA for Saxenda features a suggestion to watch sufferers for despair or suicidal ideas, however Ozempic doesn’t carry an identical warning. The load-loss drug Wegovy (semaglutide, the identical energetic ingredient as in Ozempic) consists of in its prescribing info that experiences of suicidal habits and ideation have occurred in scientific trials with different weight-management drugs, the information report mentioned.
Scientific trials in adults for Saxenda discovered that 9 folks amongst 3,300 reported suicidal ideation, whereas two in 1,900 reported suicidal ideation whereas on a placebo in these drug trials, CNN reported.
One grownup taking Saxenda tried suicide, the prescribing info says.
In pediatric scientific trials, one individual died of suicide amongst 125 trial individuals. Nevertheless, “there was inadequate info to ascertain a causal relationship to Saxenda,” in line with the prescribing info.
The Wegovy prescribing info says that sufferers ought to be monitored for despair, suicidal ideas or habits, and weird adjustments in temper or habits.
These drugs are in a category of medication referred to as GLP-1 receptor agonists. Ozempic was authorised by the FDA in 2017 for diabetes. Saxenda and Wegovy had been authorised for weight reduction in 2014 and 2021, respectively.
GLP-1 drugs stimulate the discharge of insulin, reducing blood sugar and slowing meals because it passes by way of the intestine.
The FDA informed CNN mentioned it “routinely evaluates particular person antagonistic occasion experiences and antagonistic occasion experiences from the printed literature for all authorised medicine.”
Nevertheless, it doesn’t touch upon third-party analysis “as a common matter.”
The company is continuous to watch the drugs and consider them by way of its risk-assessment applications, CNN reported.
The EMA’s security committee will think about whether or not its overview ought to prolong past the medicine in query to different medicines within the class of GLP-1 receptor agonists. This might embody Wegovy and drug firm Eli Lilly’s Mounjaro.
Extra info
The U.S. Meals and Drug Administration has extra on semaglutide.
SOURCE: CNN
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