[ 2017-04-20 ]

Drug given to pregnant women causes 'serious malformations'
Mothers treated with valproate for epilepsy were
up to four times likelier to give birth to a
malformed child, the preliminary study found.

Introduced in France in 1967, valproate is
prescribed widely worldwide.

Doctors in France are now advised not to give it
to girls, women of childbearing age and pregnant
women.

The drug's manufacturer, Sanofi, responded in a
statement that it had been "totally transparent
with health authorities".

"We are aware of the painful situation confronting
the families of children showing difficulties that
may have a link with the anti-epileptic treatment
of their mother during pregnancy," it said.

Some of those affected say France and the company
were too slow to warn of side-effects.

The risk of birth defects associated with
valproate, marketed as Epilim, Depakine, Depakote
and Stavzor among other names, has been known
since the 1980s, especially for spina bifida.

In the UK, the National Health Service (NHS)
issued an alert earlier this month saying
valproate should only be given to girls and women
of childbearing age under specialist supervision
and only when other medications had been found not
to work.

'Very high'
According to the new report (in French) by
France's National Agency for the Safety of
Medicines (ANSM), between 2,150 and 4,100 children
suffered severe malformations linked to the drug.

"The study confirms the highly teratogenic
[capable of causing birth defects] nature of
valproate," Mahmoud Zureik, ANSM's scientific
director and co-author of the report, told AFP
news agency.

"The figure of about 3,000 severe malformations is
very high."

Types of birth defects attributed to the drug
include spina bifida - which occurs when a section
of the spinal column does not form properly - and
defects of the heart and genital organs.

The risk of autism and developmental problems was
also found to be higher, and will be explored in a
follow-up report due later this year.

Women treated for bipolar disorder were at a lower
risk than those treated for epilepsy, the study
found, but were still twice as likely to give
birth to children with major birth defects.

According to ANSM, this is because women treated
for bipolar disorder were less exposed to the
drug.

In its alert issued on 6 April, the NHS noted that
valproate was an "effective medication used to
treat epilepsy and bipolar disorder" but added
that it was also aware of its "off-label" use to
treat migraine or chronic pain.

Lawsuit



Some families of children with birth defects born
to women who took the drug while pregnant -
grouped under an umbrella association known
as APESAC (in French) - have sued Sanofi, saying
that it did not adequately warn about the risks.


"The number of victims is potentially huge,"
APESAC president Marine Martin told AFP.


"We need to take into account children with
malformations and autism, as well as families that
lost a baby due to treatment during pregnancy."


Ms Martin says two of her children, a girl and a
boy, suffered physical defects brought on by
valproate.


French MP Gerard Bapt welcomed the report.


"It now appears fundamental that valproate in all
its forms should not be prescribed for women of
child-bearing age," he said.


Medically necessary exceptions, he added, should
be rare and accompanied by "mandatory
contraceptive use".

Source - BBC

... go Back