SHARE
COPY LINK

BABIES

France: Common drug caused birth defects in 450 babies

A common drug used to treat epilepsy has caused congenital defects in around 450 babies in France who were exposed to the medication before birth in the uterus, according to an estimate by health authorities published on Tuesday.

France: Common drug caused birth defects in 450 babies
Photo: AFP

The report put at between 425 and 450 “the number of cases of children born alive or stillborn exposed to valproate in utero between 2006 and 2014 who have congenital defects.”

The estimate for all of France was extrapolated from data obtained in the Rhone-Alpes region, it said.

Starting on March 1st, the warning for pregnant women – which is already in the notice that comes with valproate – will also be written on the box, the country's general director of health, Benoit Vallet, told AFP.

The anti-convulsion drug has been flagged for several years due to the high risk of birth defects – around ten percent – but also for increased risks of mental retardation and autism.

A European report in 2014 urged all countries on the continent to review their conditions for prescribing valproate “to minimise risks”.

It also called on them to take steps to ensure the medication is not prescribed to women of child-bearing age – 15 to 49 years – or pregnant women, unless no alternative treatment for epilepsy was effective.

In France, the new report noted, the drug has also been prescribed for the treatment of bipolar disorder.

Valproate has been marketed in France by pharmaceutical company Sanofi under the brand name Depakine since 1967.

Also available as a generic, the drug is sold by Sanofi in some 120 countries, the manufacturer said.

Member comments

Log in here to leave a comment.
Become a Member to leave a comment.

BABIES

France launches probe after 11 new cases of babies born without arms in rural region

Eleven more cases of babies born with missing or malformed arms in France have come to light, the public health authority said Tuesday, adding to a medical phenomenon for which no cause has been found.

France launches probe after 11 new cases of babies born without arms in rural region
Photo: AFP
The 11 additional cases were identified through hospital records in the Ain area, near the Swiss border, between 2000 and 2014.
 
Ain is one of the three French “departments” or administrative areas where cases of the upper limb deformities have been registered, along with Brittany on the West coast and Loire-Atlantique, south of Brittany.
 
On Wednesday Francois Bourdillon, head of the Public Health France agency, told RTL radio that the probe was “underway” and the results would be known “in about three months.”
 
“We are going to look into all the suspect cases,” Bourdillon said.
 
His announcement came after France's Health Minister Agnes Buzyn announced last week that a new investigation would be launched into the birth defects of 14 babies born with stunted or missing arms since 2007, half of them in Ain. That was before the 11 new cases in the Ain were announced.
   
In an October 4 report, France's public health agency said it had found no “common exposure” to substances that could explain the deformities.
   
While the cause of the defects are unknown, research has shown that exposure of the mother to certain chemicals or medication during the pregnancy can increase the risk.
 
Last week, Buzyn told French news channel LCI that environmental experts would join health experts in investigating the cases to try to shed light on the phenomenon.
 
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.
 
READ ALSO:

SHOW COMMENTS