“There are still too many pregnancies taking carbamazepine” warns the National Medicines Safety Agency (ANSM). However, this medication marketed under the name Tegretoland prescribed against epilepsy or bipolar disorders, puts the baby at risk of malformation.
Due to these risks, it is recommended not to use these medications during pregnancy. However, data from the national health system (SNDS) showed that in 2022, 274 pregnant women took it, and were therefore exposed to the risk, without necessarily knowing it.
“In order to ensure patients are fully informed about these risks, we would like to set up a shared information certificate which will be co-signed every year by the doctor and his patient. without this certificate, the pharmacist will not be able to dispense the medication” explains the ANSM.
What are the risks faced by the baby?
Carbamazepine is a “teratogenic” drug, meaning that it exposes children to a high risk of major malformations in the event of pregnancy: this risk is multiplied by 3 compared to children not exposed to an antiepileptic drug.
The malformations can be in particular: , , a malformation
- a neural tube defect (opening of the spine)
- a facial malformation, such as a cleft upper lip and palate
- a skull malformation
- heart abnormalities
- a malformation of the penis involving the urinary opening (hypospadias)
- abnormalities in the fingers.
“In this context, we remind health professionals and patients of the importance of taking these risks into account when prescribing and dispensing carbamazepine in a woman of childbearing age as well as in the event of pregnancy” insists the ANSM.
Source : ANSM press release from October 12, 2023
