A mother holding the feet of a new baby Credit: Dominic Lipinski/PA
Up to 4,100 children in France suffered severe birth defects after their mothers took the epilepsy drug sodium valproate, the French health authorities said yesterday (Thurs).
The drug, also prescribed in France for bipolar disorder, was taken by up to 100,000 pregnant women between 1967 and 2016, according to a joint report by the French National Agency for the Safety of Medicines (ANSM) and the national health insurance body.
It is also believed to have been taken by thousands of pregnant women in the UK.
Marketed in France under the brand name Depakine for epilepsy and Depakote or Depamide for bipolar disorder, it is one of the most effective and widely prescribed drugs for controlling epileptic seizures. Its British equivalent is Epilim.
Parents of the children affected say the French government and the drugâs manufacturer, Sanofi, were too slow to warn of the drugâs side-effects although the risks to foetuses were known by the early 1980s.
Sanofi, was not immediately available for comment.File photo dated 01/04/14 of a pregnant woman.Â Credit: Andrew Matthews/PA
Some families of children born with birth defects to women who took the drug while pregnant are suing the company, claiming that it failed to warn them adequately of the risks.
Legal action against the company and authorities was brought with the help of members of an association aiding parents known as APESAC.Â
Dominique Martin, director-general of the ANSM, last year acknowledged on French television that âthere was a delay in informing mothers and families.â
The alarm was sounded and warnings issued in France in 2014 â and in 2016 in Britain.
The drug can cause spina bifida, a condition in which the spinal cord does not form properly and can protrude through the skin, as well as defects of the heart and genital organs. The risk of autism and developmental problems was also found to be higher, and will be quantified in a follow-up report due later this year.
An earlier estimate suggested that 30 to 40 percent of children exposed in the womb could suffer such disorders.Depakine
The drug has been on sale since 1967 in France and in Britain since 1973.
In France, the drug is no longer advised for pregnant women with epilepsy but may still be prescribed if all other treatments fail. The ruling has only been in place since 2015.
In Britain sodium valproate carries a warning that the risk of developmental problems in unborn babies is higher than for other anti-epileptic drugs if taken during pregnancy. The Epilepsy Society advises counselling before conception.
Women who took the drug during pregnancy to treat epilepsy were four times more likely to give birth to babies with congenital malformations, the report found. Bipolar women taking the drug were twice as likely to give birth to children with major birth defects.
Mahmoud Zureik, a co-author of the report and scientific director of the French drugs regulator, said the lower risk for bipolar women was probably because doctors tended to stop prescribing the drug earlier in the pregnancy.
Alain Weil, a researcher at the French health insurance administration who wrote the report with Dr Zureik, said: âThe risk of severe malformation is limited to the first six months of pregnancy.âÂ
Dr Zureik downplayed an earlier claim by APESAC that the number of victims since 1967 could be as high as 30,000, although he said: âThe study confirms the highly teratogenic [that is, capable of causing birth defects] nature of valproate.â
The study estimated the number of children who suffered birth defects as a result of the drug between 2,150 and 4,100.
In Britain, the campaign group In-Fact has long been urging doctors to give patients better information about the high risk to foetuses.