The Spanish Agency for Medicines and Health Products (AEMPS) warned this Thursday of the preliminary results of a study that suggest an increased risk of neurodevelopmental disorders in children whose male parents were treated with valproate in the 3 months prior to conception.
The study, noted the AEMPS, has certain limitations whose impact on the validity of the results is still unknown, for which reason the European authorities have requested additional information from the pharmaceutical companies that produce the drug to assess the robustness of the data.
What is valproate?
According to the Spanish Agency for Medicines and Health Products, medicines containing valproate and its derivatives are indicated for the treatment of epilepsy and as a second option in manic episodes of bipolar disorder.. There are 10 authorized presentations of these drugs in Spain, both in generic form and under the Depakine brand (Sanofi Aventis).
What should I do if I am a man and take valproate?
The health authorities indicate that if you are a man or a male adolescent and you are being treated with valproate you should not stop treatment without first talking to your doctor, as the symptoms of your disease could reappear.. The possible risks of the drug refer to the offspring, so the recommendation is to assess with your doctor the need to use effective contraceptive measures.. In the same way, it also recommends notifying your specialist of your intention to become a father if you are undergoing treatment with the drug.
Is there a risk also in women?
Teratogenic effects in case of maternal exposure to valproate were already known. In fact, there are preventive measures to avoid maternal exposure during pregnancy. In 2022, the court found a relationship between the neuronal damage of three children and the consumption of this antiepileptic by their mothers, for which reason the manufacturer of Depakine (Sanofi Aventis) was ordered to compensate the affected families.
Currently, the AEMPS establishes that valproate or valproic acid should not be used in girls and women with childbearing capacity, unless another therapeutic alternative can be used and the conditions of the established pregnancy prevention plan are met.. Likewise, it establishes that pregnant women should not use valproic acid in bipolar disorder and, in the case of epilepsy, it can only be used if no other therapeutic alternative is possible.. The pregnancy prevention plan includes the evaluation of the possibility of pregnancy in all women, and that the patient in treatment agrees to use contraceptives, undergo regular pregnancy tests and consult with the doctor in the case of planning a pregnancy or if it is she is pregnant. In addition, it is established that the treatment be reviewed at least once a year.
What risks have been verified in treated women?
Studies carried out show a risk of long-term neurodevelopmental disorders in children born to women treated with the drug (up to 40% of cases), as well as its known risk of congenital malformations (in approximately 10% of cases). the cases).