Ozempic, Saxenda drugs under EU probe over reports of suicidal thoughts – National | 24CA News
The European Medicines Agency (EMA) is investigating Novo Nordisk’s NOVOb.CO diabetes drug Ozempic and weight-loss therapy Saxenda after Iceland’s well being regulator flagged three instances of sufferers desirous about suicide or self-harm.
Shares of the Danish drugmaker fell one per cent on Monday following the news.
An EMA security committee is wanting into antagonistic occasions raised by the Icelandic Medicines Agency, together with two instances of suicidal ideas in those that used Ozempic, which accommodates the energetic ingredient semaglutide, and Saxenda, the regulator stated.
Another affected person on Saxenda, Novo’s earlier and fewer efficient weight-loss drug that accommodates a unique energetic ingredient, reported ideas of self-injury, the company stated.
Novo Nordisk stated affected person security was high precedence and it handled all experiences about antagonistic occasions very significantly.
Safety information didn’t present any “causal association” between the suicidal or self-harming ideas and the medicine, it added in a press release.
The EMA’s investigation facilities on medicines that include both semaglutide or liraglutide. Novo’s weight problems therapy Wegovy, for which demand has surged within the United States, accommodates semaglutide, whereas Saxenda accommodates liraglutide.
The evaluate has been introduced weeks after the regulator raised a thyroid most cancers security sign, a way to watch probably antagonistic results, on a number of of Novo’s merchandise that include semaglutide.
Suicidal ideas will not be listed as a aspect impact within the EU product data of the remedies.
In the United States, nonetheless, directions for Wegovy suggest that sufferers are monitored for suicidal ideas or habits.
According to the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) Public Dashboard, there have been at the very least 60 experiences of suicidal ideation since 2018 from sufferers on semaglutide or their well being care suppliers.
In addition, FAERS has obtained at the very least 70 such experiences from customers of liraglutide or their well being care suppliers since 2010.
Information in FAERS experiences has not been verified and the existence of a report will not be proof of causation, the FDA says. The company didn’t instantly reply when requested whether or not it plans to check any hyperlink.
Side results have hobbled a number of earlier makes an attempt by the drug trade to develop profitable weight-loss medicine.
Sanofi’s SASY.PA Acomplia, which by no means received a U.S. approval, was withdrawn in Europe in 2008 after being linked to suicidal ideas.
Acomplia was designed to change elements of the nervous system that regulate urge for food. New weight-loss medicine corresponding to Wegovy, nonetheless, regulate urge for food by mimicking a intestine hormone, and never straight interfering with mind chemistry.
The EMA stated on Monday it could take into account whether or not the evaluate ought to be prolonged to different medicines of the identical class often known as GLP-1 receptor agonists.
Penny Ward, a visiting professor in pharmaceutical drugs at Kings College in London and an skilled on drug security monitoring within the EU, stated it was unclear why the very small variety of experiences triggered the EMA’s evaluate, however that it may lead to a severe motion corresponding to one of many merchandise being withdrawn from the market.
“It’s more likely that this results in a change to the labeling, so that prescribers are made aware of this possible effect so they can warn patients and look out for people who may be particularly susceptible to this kind of problem,” Ward stated.
