Sanofi Depakote epilepsy drug that reportedly caused birth defects in 10,000 unborn babies

Valproate Semisodium, better known as Depakote, has reportedly put more than 10,000 pregnant women at risk in France, and there are raising concerns that the same amount of women in the U.K. may also be affected by the epilepsy drug.

Our Group Action Lawyers are investigating the issues, and anyone affected here in the U.K. is free to come forward for confidential and no obligation advice.

Epilepsy drug and its risks

Depakote is a well-known drug widely used for patients as treatment for epilepsy, bipolar disorders, and as a prevention for migraines. Recently, reports have shown that taking the epilepsy drug during pregnancy could have adverse effects on the baby, where the baby is at a higher risk of developing seizures when they’re older, as well as possibly numerous birth defects, such as cleft lip, cleft palate, spina bifida, and atrial septal defect.

Some other reports have revealed that mothers taking the drug put their baby at risk of mental health problems as well. According to the Telegraph, 40 percent of the babies who were exposed to the drug developed neuro-developmental disorders like autism, which is a very concerning statistic.

The report’s findings…

The report published by the French Agency for the Safety of Health Products – ANSM – and its national health insurance body – CNAMTS – saw the government accused of being a party to a nationwide “cover up”.

The report was leaked to Le Canard Enchaine, who undertakes investigative journalism in France. According to the report, 10,000 women have taken the drug between 2007 and 2014 even though there were well-known high risks of birth defects among new-born babies.

Class-action

A French association reports that around 2,900 families affected by the drug have “launched a class action against pharmaceutical company Sanofi”. The action taken against Sanofi is for the failure “to properly inform users about the drug’s potential risks for developing foetuses”.

Does this affect individuals the U.K.?

Research in the U.K. suggests that children born to mothers who took the epilepsy drug during pregnancy are six to ten times more likely to have a neuro-developmental disorder.

Online magazine Epilepsy Today didn’t mention any birth defect risks, but did detail that babies were more likely to develop autism, attention deficit hyperactivity disorder (ADHD), and/or dyspraxia.

Although there has been a reportedly long-established risk to pregnant women, pharmaceutical companies apparently didn’t display the risk until July this year.

The Electronic Medicines Compendium (EMC), who keeps up-to-date about prescription medicines, highlights the risks associated with taking the Depakote. They strictly warn that pregnant women shouldn’t take the drug ‘unless alternative treatments are ineffective’ because it can expose their unborn baby to developmental disorders.

They also note that there is limited data on the long term outcomes. The warning derived from meta-data analysis shows that 10.73% of babies exposed to the epilepsy drug during the pregnancy will suffer from congenital malformations, ranging from facial dysmorphism, cleft lip and palate, to multiple anomalies involving various body systems.

Depakote has been on sale in the U.K. since 1973, meaning it could have affected thousands of babies, as users have only been informed of the health warnings and risks recently. However, a British awareness group, FACSA, allege that women are still not well-informed of the risks of taking the drug.

A British woman, Janet Williams, whose two sons suffered birth defects – allegedly from taking the drug – has been campaigning for the Medicines and Healthcare products Regulatory Agency (MHRA) to put warnings on the boxes. It took the health agency more than six months to produce these warning labels, and the government believe that around 7,000 babies may have been harmed from the drug. However Mrs Williams believes the figure to be much higher.

Sources:

https://www.medicines.org.uk/emc/medicine/25947

http://www.telegraph.co.uk/news/2016/08/10/ten-thousand-pregnant-frenchwomen-took-epilepsy-drug-that-raises/

https://www.epilepsy.org.uk/news/news/epilim-and-pregnancy

https://www.drugs.com/depakote.html

https://www.drugwatch.com/depakote/side-effects/