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BIRTH

14,000 pregnant women in France took ‘birth defect drug’

According to a study released by health authorities on Wednesday, a total of 14,322 pregnant women in France took a medicine between 2007 and 2014 which has been linked to birth defects.

14,000 pregnant women in France took 'birth defect drug'
Dépakine has been linked to an increased risk of various congenital defects. File photo: AFP

Valproate, the active substance in anti-convulsion drug Dépakine, prescribed in France for epilepsy and bipolar disorder, has been linked to heart, kidney and spine defects as well as autism and developmental delays. Authorities have been sharply criticized for their slow reaction in preventing pregnant women from taking the drug.

In total, 8701 children were born to women taking the drug over the seven-year period, the study published on Wednesday said, accounting for two in every 1000 pregnancies in France over the period.

This is despite the fact that since 2006, the leaflet enclosed with the drug advised against taking it during pregnancy; this warning was added to the outer box in 2014. It wasn't until 2014 that a European report urged all countries on the continent to review their conditions for prescribing valproate “to minimize risks”.

A compensation scheme will be established for those affected, Health Minister Marisol Touraine said on Wednesday.  Parliament will vote on the scheme later in the year. Touraine also pledged that in the next six months, further measures would be put in place to support the patients “completely”.

The study, published by ANSM (French National Agency for Medicines and Health Products Safety), did not give a figure for how many of the babies suffered from birth defects due to the exposure to the drug.

However, previous studies on the effects of valproate have shown that babies born to mothers who have taken the substance have a ten percent risk of suffering from heart, kidney or spine defects, and a 30-40 percent risk of being affected by delayed development or autism.

A report released in February by France's social affairs inspectorate (IGAS) estimated that around 450 French babies had been born with congenital defects after being exposed to valproate in utero. The inspectorate arrived at this number by extrapolating data obtained in the Rhone-Alpes region, it said.

Then, IGAS criticized “the lack of reactivity” from ANSM and Sanofi, the pharmaceutical company which has produced the drug in France since 1967. In 2008, two years after the drug was officially not recommended to be taken during pregnancy, an IGAS study showed that one in five doctors and one in three pharmacists were still unaware of the effects of valproate on unborn children.

“This is a huge health scandal that could have affected between 50,000 and 70,000 people over 50 years of prescription,” said Marine Martin, president of Apesac, an organization set up to assist parents affected by Dépakine, cited by Ouest-France. According to Apesac's figures, 2426 babies have been affected by the drug, of whom 401 have died.

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BIRTH

France investigates spike in babies born with arm defects

France's health minister on Sunday announced a new investigation into the births of several babies with upper limb defects in various parts of the country in recent years, saying it was "unacceptable" no cause had been found.

France investigates spike in babies born with arm defects
Photo: Depositphotos
Health Minister Agnes Buzyn said she and her environment counterpart Francois de Rugy had decided to look more closely at what caused 14 babies to be born with stunted or missing arms since 2007, two weeks after health authorities said they had failed to find an explanation.
 
The cases have been concentrated in three French “departments” or administrative areas: Ain near the Swiss border, which had seven cases between 2009 and 2014; Brittany on the West coast which had four cases between 2011 and 2013; and Loire-Atlantique, south of Brittany, which had three cases in 2007-2008.
 
 
In an October 4 report France's public health agency said that while the number of cases in the Ain area was not above the national average, the numbers in Brittany and Loire-Atlantique were statistically “excessive”. But it said it found no “common exposure” to substances that could explain them.
 
Fewer than 150 babies are born each year in France with upper limb defects, which occur when part of, or the entire arm, fails to form completely during pregnancy. While the cause of the defects is unknown, research has shown that exposure of the mother to certain chemicals or medication during the pregnancy can increase the risk.
 
Buzyn told LCI channel that environmental experts would now join health experts in investigating the cases to try to shed light on the phenomenon.
 
“We cannot content ourselves with saying we didn't find the case, that's unacceptable,” she said.
 
In the 1950s and 1960s, thousands of babies around the world were born with missing or stunted limbs linked to the use of the drug thalidomide, which was used to treat nausea in pregnant women. It was banned in the 1960s.