EU investigates Ozempic, weight-loss drug Saxenda after suicidal
thoughts reported
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[July 11, 2023]
By Ludwig Burger and Maggie Fick
(Reuters) -The European Medicines Agency (EMA) is investigating Novo
Nordisk's 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.
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A pharmacist displays boxes of Ozempic,
a semaglutide injection drug used for treating type 2 diabetes made
by Novo Nordisk, at Rock Canyon Pharmacy in Provo, Utah, U.S. March
29, 2023. REUTERS/George Frey/File Photo
In clinical trials for Ozempic and
Saxenda, Novo excluded people with a history of psychiatric
disorders or recent suicidal behavior.
Sanofi's Acomplia, which never won U.S. approval, was withdrawn in
Europe in 2008 after being linked to suicidal thoughts.
Acomplia was designed to modify parts of the nervous system that
regulate appetite. New weight-loss drugs such as Wegovy regulate
appetite by mimicking a gut hormone, and not directly interfering
with brain chemistry.
Diet pills Contrave by Orexigen Therapeutics and Qsymia by Vivus
Inc, approved in the U.S. in 2014 and 2012, respectively, carry
warnings on their labels about increased risk of suicidal thoughts.
Markus Manns, senior portfolio manager at Union Investment and a
Novo shareholder, said that a low incidence of suicidal thoughts
might be acceptable for a drug against Type 2 diabetes but not for a
weight-loss drug.
The EMA said on Monday it would consider whether the review should
be extended to other medicines of the same class, known as GLP-1
receptor agonists.
The EMA's ongoing thyroid cancer investigation includes all GLP-1s.
Other drugs in the class include Eli Lilly and Co's Mounjaro. Lilly
did not respond to a question from Reuters on whether the EMA had
contacted them to provide data for the new investigation.
Penny Ward, a visiting professor in pharmaceutical medicine at Kings
College in London and an expert on EU drug safety monitoring, said
the most likely outcome of the investigation would be a change in
the drug's label in the EU to carry a warning of the possible side
effect of suicidal thoughts.
Another drug safety expert, who spoke on condition of anonymity,
said the small size of Iceland's population might have led
regulators to consider only a few adverse event cases were a
significant proportion and worth investigating.
(Reporting by Ludwig Burger in Frankfurt and Maggie Fick in London;
Additional reporting by Bhanvi Satija in Bengaluru, Michael Erman
and Patrick Wingrove in New York, Robin Respaut in San Francisco,
Louise Breusch Rasmussen in Copenhagen and Jennifer Rigby in London;
Editing by Savio D'Souza, Nivedita Bhattacharjee, Sriraj Kalluvila
and Barbara Lewis)
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