SPAIN’S Agency for Medicines and Health Products (AEMPS) has begun an investigation into weight-loss drugs Ozempic and Saxenda for possible side effects not mentioned in warning leaflets.
It follows an alert issued on Tuesday by the European Medicines Agency(EMA) after Iceland reported three patients taking these drugs had suicidal thoughts or self-harm.
Specifically, two who were taking Ozempic, a diabetes drug based on an active ingredient called semaglutide that is also used very frequently for weight loss, but brings on suicidal moods.
One person taking Saxenda, an older, less effective weight-loss drug (the active substance of which is liraglutide) had thoughts of self-harm.
At the moment, a causal relationship between those incidents and the taking of the drugs produced by Novo Nordisk and taken by 20 million people a year has not been confirmed.
The pharmaceutical company has issued a statement assuring that its priority is patient safety.
The procedure that is now being initiated in Europe will try to clarify to what extent medicines are causing these behaviours and, if so, what is the probability of their happening.
A spokesperson for the AEMPS explained that when a country detects an increase in the number of cases with a common factor, or patterns change, a warning signal is sent by the EMA;
That enables all countries to review possible cases and an investigation is carried out to see if there is a causal relationship between one event and another.
It essentially puts the focus on the drugs with exhaustive searches in databases to detect more anomalies and request more information, if necessary.
Although at the moment all the research is based on only three cases, there is already a history of weight loss drugs that produce these effects.
Those containing semaglutide were already in the spotlight after US health authorities detected at least 60 reports of suicidal ideation since 2018 from patients taking this active ingredient.