Epilepsy drug linked to 4,000 birth defects
UP TO 4,100 children suffered major malformations in the womb after their mothers took a treatment against epilepsy and bipolar disorders known as valproate between 1967 and 2016, France’s drug regulator, ANSM, has said.
Valproate, which has been made in France by Sanofi under the brand Depakine for epilepsy and Depakote and Depamide for bipolar disorders, is also believed to cause slow neurological development, ANSM said yesterday.
Sanofi said it had been transparent with the authorities and that it had sought to keep doctors and patients abreast of medical information.
Parents of those affected, however, say the French state and Sanofi were too slow to warn of the side effects, after the risks to foetuses became clear by the early 1980s.
The French drug authority said it would also publish a study on neurological effects of valproate later this year.
Valproate was approved as an anti-epileptic drug in France in 1967 and has become one of the most widely prescribed treatments worldwide given its effectiveness on adult patients.
Depakine, which lost its patent in 1998, is prescribed in over 100 countries.