BFMTV INFO. Anti-obesity drugs: EU investigates "cases of adverse effects in pregnant women"

Caution is advised. The French drug regulatory authority announced this Friday, June 20 , that it is authorizing all French doctors to prescribe anti-obesity medications (without reimbursement). Until now, only specialists in endocrinology, diabetology, and nutrition could prescribe them.

But, as BFMTV learned from the European Medicines Agency (EMA), these treatments are not without risks. GLP-1 drugs have reportedly caused adverse effects in pregnant women.

"The EMA is investigating reports of adverse events occurring during pregnancy and will review the need to regulate or communicate" these events, the agency explained in a message.

Asked to specify the number, nature, or location in Europe of these incidents, the EMA declined to comment until it had completed its investigations. However, similar problems have been reported in the United Kingdom, according to the British health authority (MHRA) quoted by Skynews .

40 problematic cases have been brought to the attention of the MHRA, the vast majority of which were in mothers who had taken Mounjaro (26) compared to 8 for Ozempic and Wegovy. Note that Ozempic is not indicated in France for the treatment of obesity, only diabetes.

These adverse events, currently under investigation, are regrettable, but they are not part of normal product use. Thus, as the French agency reminded BFMTV, "if you are planning to become pregnant or if you become pregnant, semaglutide treatment must be discontinued. Semaglutide must be stopped at least two months before planning to become pregnant due to its long half-life."

The same applies to breastfeeding, as the risk to the breastfed child "cannot be excluded", it is therefore recommended not to combine taking this medication with breastfeeding.

How can we explain serious cases when their use is clearly contraindicated? Because recommendations are not always followed, particularly due to a parallel circuit specific to these fashionable products, with cases of self-medication, as the French Society of Encrinology had deplored.

According to health insurance data, at least 1.5% of patients taking Ozempic misuse it. These figures are "very likely underestimated," according to the ANSM, which noted in July 2024 that these figures "only take into account medications dispensed in pharmacies and reimbursed."

While the EMA indicates it is working on the issue of adverse effects during pregnancy, other potential problems have already been identified. In July 2023, the European agency announced it was examining a possible correlation between taking the treatment and "the risks of suicidal thoughts and self-harm with medications."

Other notable side effects include pancreatitis and intestinal obstruction, while other potentially more serious disorders are being studied. "These are prescription drugs that require medical supervision, including blood tests. These are not harmless drugs," insisted Bruno Maleine, a member of the National Order of Pharmacists, speaking to BFMTV.com in December 2022.