“Possible Self-harm and Suicidal Side Effects of “Miracle Weight-Loss Drug”?
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“Possible Self-harm and Suicidal Side Effects of “Miracle Weight-Loss Drug”?
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“Possible Self-harm and Suicidal Side Effects of “Miracle Weight-Loss Drug”? UK Joins EU in Conducting Review.
According to media reports, following the European Medicines Agency (EMA), the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has also initiated a review of GLP-1 class drugs produced by the Danish pharmaceutical company Novo Nordisk.
Previous reports indicated a potential risk of patients experiencing self-harm or suicidal tendencies due to the medication.
On Tuesday (July 25th), the MHRA confirmed to the media that they are examining data from two drugs, Ozempic (used for diabetes) and Saxenda (used for weight loss), both containing the active ingredients semaglutide and liraglutide, respectively, which are part of Novo Nordisk’s GLP-1 drugs.
In simple terms, these drugs mimic a hormone called GLP-1 produced in the intestines, sending signals to the brain that make the person believe they are “full,” thereby controlling their diet.
The MHRA stated that the review process was initiated earlier on July 12th, and it includes not only the two mentioned drugs but also AstraZeneca’s exenatide, Sanofi’s lixisenatide, and Lilly’s dulaglutide.
The MHRA’s review will consider safety data, including reports of adverse drug reactions from patients, clinical professionals, and other undisclosed regulatory authorities.
Reports indicate that between 2020 and July 6th, 2023, the MHRA received five reports related to “suspected adverse drug reactions of self-harm or suicidal behavior” associated with semaglutide through its drug side-effect reporting system, known as the “Yellow Card scheme.”
Furthermore, between 2010 and July 6th, 2023, the MHRA received twelve cases involving liraglutide, with suspected adverse drug reactions linked to “self-harm or suicidal behavior.” However, the agency emphasized that the reports alone cannot establish a causal relationship.
Alison Cave, Chief Safety Officer at MHRA, stated, “Patient safety is our top priority. We will carefully assess all available evidence and provide further advice to patients and healthcare professionals accordingly.” The MHRA also noted that although Ozempic is not approved for weight loss in the UK, it is often used off-label for this purpose.
Two weeks ago, the European Medicines Agency (EMA) also launched an investigation into Ozempic and Saxenda after Iceland’s regulatory authorities reported three cases of patients having suicidal thoughts after using these drugs, including two cases involving Ozempic and one involving Saxenda.
It is worth noting that suicidal tendencies have not been listed as side effects in the product information within the European Union. However, in the United States, for the weight-loss indication of semaglutide (branded as Wegovy), monitoring of patients for suicidal thoughts or behaviors is advised in the prescription information.”
“Possible Self-harm and Suicidal Side Effects of “Miracle Weight-Loss Drug”?
(source:internet, reference only)
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