EU Investigating Ozempic After Suicidal Thoughts Reported
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2023-10-10
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EU Investigating Ozempic After Suicidal Thoughts Reported.
The European Medicines Agency (EMA) is investigating Novo Nordisk's (NOVOb.CO) diabetes drug Ozempic and weight-loss treatment Saxenda after Iceland's health regulator flagged three cases of patients thinking about suicide or self-harm.
Shares of the Danish drugmaker fell 1% on Monday following the news.
An EMA safety committee is looking into adverse events raised by the Icelandic Medicines Agency, including two cases of suicidal thoughts in those who used Ozempic, which contains the active ingredient semaglutide, and Saxenda, the regulator said.
Another patient on Saxenda, Novo's earlier and less effective weight-loss drug that contains the active ingredient liraglutide, reported thoughts of self-injury, the agency said.
Iceland's drugs regulator did not immediately respond to requests for details.
Novo Nordisk said patient safety was top priority and it treated all reports about adverse events very seriously. Its own safety monitoring so far found no "causal association" between the self-harming thoughts and the drugs, it said in a statement.
The EMA's investigation centres on medicines that contain either semaglutide or liraglutide. Novo's obesity treatment Wegovy, for which demand has surged in the United States, contains semaglutide.
The review was announced weeks after the regulator raised a thyroid cancer safety signal, a means to monitor potentially adverse effects, on several of Novo's products containing semaglutide.
Suicidal thoughts are not listed as a side effect in the EU product information for either drug.
In the United States, however, prescribing instructions for Wegovy recommend that patients are monitored for suicidal thoughts or behaviour.
According to the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) Public Dashboard, there have been at least 60 reports of suicidal ideation since 2018 from patients on semaglutide or their health care providers.
FAERS has received at least 70 such reports since 2010 from users of liraglutide or their health care providers.
Information in these reports has not been verified and the existence of a report is not proof of causation, the FDA says.
The FDA said it monitors safety of drugs throughout their life cycle. Wegovy's trials did not suggest increased risk of suicidal behavior, but the drug's label contains a warning for suicidal behavior and ideation because of risks associated with other weight management drugs, the regulator said.
SENSITIVE
Although Iceland's regulator has flagged only three cases, the issue of suicidal thoughts linked to weight-loss drugs is sensitive and has hobbled previous attempts by the drug industry to develop lucrative weight-loss drugs.
In clinical trials for Ozempic and Saxenda, Novo excluded people with a history of psychiatric disorders or recent suicidal behavior.
Sanofi's (SASY.PA) Acomplia, which never won U.S. approval, was withdrawn in Europe in 2008 afte
The European Medicines Agency (EMA) is investigating Novo Nordisk's (NOVOb.CO) diabetes drug Ozempic and weight-loss treatment Saxenda after Iceland's health regulator flagged three cases of patients thinking about suicide or self-harm.
Shares of the Danish drugmaker fell 1% on Monday following the news.
An EMA safety committee is looking into adverse events raised by the Icelandic Medicines Agency, including two cases of suicidal thoughts in those who used Ozempic, which contains the active ingredient semaglutide, and Saxenda, the regulator said.
Another patient on Saxenda, Novo's earlier and less effective weight-loss drug that contains the active ingredient liraglutide, reported thoughts of self-injury, the agency said.
Iceland's drugs regulator did not immediately respond to requests for details.
Novo Nordisk said patient safety was top priority and it treated all reports about adverse events very seriously. Its own safety monitoring so far found no "causal association" between the self-harming thoughts and the drugs, it said in a statement.
The EMA's investigation centres on medicines that contain either semaglutide or liraglutide. Novo's obesity treatment Wegovy, for which demand has surged in the United States, contains semaglutide.
The review was announced weeks after the regulator raised a thyroid cancer safety signal, a means to monitor potentially adverse effects, on several of Novo's products containing semaglutide.
Suicidal thoughts are not listed as a side effect in the EU product information for either drug.
In the United States, however, prescribing instructions for Wegovy recommend that patients are monitored for suicidal thoughts or behaviour.
According to the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) Public Dashboard, there have been at least 60 reports of suicidal ideation since 2018 from patients on semaglutide or their health care providers.
FAERS has received at least 70 such reports since 2010 from users of liraglutide or their health care providers.
Information in these reports has not been verified and the existence of a report is not proof of causation, the FDA says.
The FDA said it monitors safety of drugs throughout their life cycle. Wegovy's trials did not suggest increased risk of suicidal behavior, but the drug's label contains a warning for suicidal behavior and ideation because of risks associated with other weight management drugs, the regulator said.
SENSITIVE
Although Iceland's regulator has flagged only three cases, the issue of suicidal thoughts linked to weight-loss drugs is sensitive and has hobbled previous attempts by the drug industry to develop lucrative weight-loss drugs.
In clinical trials for Ozempic and Saxenda, Novo excluded people with a history of psychiatric disorders or recent suicidal behavior.
Sanofi's (SASY.PA) Acomplia, which never won U.S. approval, was withdrawn in Europe in 2008 afte
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