The European Medicines Agency (EMA) announced on Tuesday that it is reviewing the available data on the risk of suicidal thoughts and self-harm associated with GLP1 analogue medicines, including Ozempic, Saxenda and Wegovy, which are used for weight loss and to treat type 2 diabetes.
The PRAC safety committee initiated this review after Iceland’s medicines agency looked at 150 reports of “suicidal ideation and self-harm” in people using GLP1 analogue drugs, including drugs available in the EU such as Ozempic (semaglutide), Saxenda ( liraglutide) and Wegovy (semaglutide).
“The drugs liraglutide and semaglutide are widely used, with an exposure of more than 20 million patients a year to date. It is not yet clear whether the reported cases are related to the drugs themselves or to the underlying conditions of the patients or other factors.
However, the PRAC is doing this review in the context of a signal about a ‘potentially caused adverse event’ by the medicine, but this ‘does not necessarily mean’ that the medicine in question caused it and may just be coincidental.
Saxenda and Wegovy are authorized in the EU for weight control, along with diet and physical activity in overweight or obese people when there is at least one weight-related health problem.
Ozempic is authorized for the treatment of adults with type 2 diabetes, also as a supplement to diet and exercise, but the EMA warns that “it has been used in an unauthorized way to lose weight.” So far, suicidal ideation does not currently appear as a side effect of GLP1 analogue drugs.
The review of Ozempic, Saxenda and Wegovy began on July 3 and has been expanded to include other similar drugs, although the review is not expected to conclude until next November.
