Ozempic: EU interested in new reported side effect

Ozempic EU interested in new reported side effect

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    The European Medicines Agency is investigating a possible side effect of Ozempic and Saxenda, drugs used to treat obesity and type 2 diabetes, and increasingly popular among young people for weight loss. . This investigation follows the report by the Icelandic Medicines Agency of two people who had suicidal thoughts after taking these drugs.

    Ozempic and Saxenda are medications that stimulate insulin secretion after a meal, thus helping to regulate blood sugar levels. They are used in the treatment of obesity and type 2 diabetes. They are also said to promote weight loss. In a press release published on July 11, 2023, the European Medicines Agency (EMA) indicates that one of its committees is investigating a possible risk of thoughts of self-harm and suicide linked to taking Ozempic and Saxenda. This follows the Icelandic Medicines Agency’s report of two people experiencing suicidal thoughts after taking Ozempic and Saxenda.

    A risk currently being assessed

    This investigation was started in the context of the adverse reaction reporting procedure. A report constitutes information on the occurrence of a new adverse effect which may have been caused by a medicinal product or on a new event concerning a known adverse effect requiring further research”, wrote the EMA in its press release. “The presence of a report does not mean that the medicine is actually responsible for the side effect in question”she added.

    The medicines regulator in Europe also reveals that its safety committee is assessing the risk of thoughts of self-harm and suicide in people who use a medicine containing semaglutide (the molecule contained in Ozempic) or liraglutide (molecule contained in Saxenda) to lose weight.

    Further monitoring of people at risk?

    Interviewed by Healthline, Dr. Kishore M. Gadde, a psychiatrist in California, said that the cases identified by the Icelandic Medicines Agency suggest a possible link between these drugs and an increased risk of suicidal thoughts, but do not show in no case a cause and effect effect. These events coincide with the results of several clinical trials of the drug Saxenda which showed that less than 1% of people taking this treatment reported suicidal thoughts. This information is also included in the medication leaflet. “Although these clinical trials showed a possible link, it was not strong enough to establish a cause and effect link.”, commented Dr Gadde.

    Note, however, that the drug Rimonabant (treatment for obesity) was recently withdrawn from the market after a clinical trial showed that this drug was associated with an increased risk of anxiety, depression and suicide.

    Another doctor interviewed by the Healthline site recommends that doctors prescribing these drugs only warn patients with a history of depression or mood disorders. Dr. Mir Ali, a bariatric surgeon in California, doesn’t see these isolated cases as a major threat to people who take these drugs. “Ozempic and other drugs like it have been sold for many years, and thoughts of self-harm and suicide have never been considered a common side effect.”, he concluded.

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