Effects of Depakine on pregnant women

26.6.2018

Question for written answer E-003501-18
to the Commission
Rule 130
Marina Albiol Guzmán (GUE/NGL)

Depakine is a drug that has been on the market since 1980. Initially approved for the treatment of epilepsy, it was later used to treat bipolar disorder and, from 1996, was also prescribed for migraines.

It was not until December 2014 that the Sanofi laboratory alerted health practitioners to its possible effects on pregnant women or the risks of foetus malformation. A number of organisations have expressed concern that it is, even now, used for emergency treatment without strict supervision. The Pharmacovigilance and Risk Assessment Committee (PRAC) has now issued instructions for more information to be given to women.

According to a press statement issued by the French association of people affected by the drug, 14 000 cases have been registered.

1. Have medication assessment protocols been reviewed or revised to analyse possible shortcomings, especially during the post-marketing period and with regard to information for health practitioners?

2. Does the Commission have any estimates or records of the number of people affected in the Union and the nature of the resulting disorders?

3. What has been done or will be done to treat those affected?