Information from the President of URPL regarding the European Medicines Agency's PRAC Committee's review of data on the risk of suicidal thoughts during therapy with GLP-1 receptor agonists.
Ozempic vs. suicidal thoughts. Polish government agency keeps its hand in. Reassured?
Published July 18, 2023 09:38
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The EMA's safety committee, PRAC, is reviewing data on the risk of suicidal thoughts and thoughts of self-harm associated with the use of drugs known as GLP-1 receptor agonists (dulaglutide, exenatide, liraglutide, lixisenatide and semaglutide), including Ozempic (semaglutide), Saxenda (liraglutide) and Wegova (semaglutide). These drugs are used to reduce weight and treat type 2 diabetes.
The review was initiated by Iceland's drug agency after reports of suicidal thoughts and self-harm in users of drugs containing liraglutide and semaglutide. To date, authorities have collected and are analyzing about 150 reports of possible cases of self-harm and suicidal thoughts.
Drugs containing liraglutide and semaglutide are widely used, and exposure to the drug has so far amounted to more than 20 million patient -years (one patient-year is the equivalent of one patient taking the drug for a year). It is not yet clear whether the reported cases are related to the drugs themselves or to patients' concomitant diseases or other factors.
The review is conducted in the context of a signal procedure. A signal is information about a new adverse event potentially caused by a drug or a new aspect of a known adverse event that requires further investigation. The presence of a signal does not necessarily mean that the drug caused the adverse event in question.
The drugs Saxenda and Wegova are approved for weight loss in combination with diet and physical activity in obese or overweight people with at least one weight-related health problem. Ozempic is approved for the treatment of adults with inadequately controlled type 2 diabetes as an adjunct to diet and exercise, but has been used outside of weight loss indications. Suicidal behavior is not currently listed as an adverse reaction in the EU product information for GLP-1 receptor agonists.
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The drug review of Ozempic, Saxenda and Wegova began on July 3, 2023, and has now been expanded to include other GLP-1 receptor agonists. The review is expected to conclude in November 2023.
Information on the start of safety signal reviews is available in the published agendas of monthly PRAC plenary meetings, and the results of the reviews are published on a special website. The results of some signal reviews will also be included in monthly PRAC highlights. In some cases, such as when there is strong public interest, the EMA may issue a news release during a signal review.
As with all medications, patients and healthcare professionals are advised to use GLP-1 receptor agonists according to the approved product information. Patients and healthcare professionals should also report suspected adverse reactions to authorities. Information on how to report suspected side effects is available in package inserts and on the websites of national drug authorities.
Read more: https://www.ema.europa.eu/en/news/ema-statement-ongoing-review-glp-1-receptor-agonists
Source: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
