E-Drug: France Imposes Partial Ban on 'Essential' Epilepsy Medicine Sodium
Valproate
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[please can you share information with Rizwan about valproate restrictions in your country at Syed Ahmad <drugsafetyconsultant@gmail.com> BS]
According to the UK journal Lancet report published online today, France
has imposed a partial ban on the prescription of popular anti-epileptic
drug sodium valproate in women and girls of reproductive age amid reports
of birth defects and developmental anomaly. According to a study by the
French drug regulatory agency released in April this year up to 4,100 birth
defects were observed in children born to pregnant mothers who were exposed
to valproate between 1967 and 2016.
In April 2017, the UK regulatory agency MHRA also issued a safety advice
for healthcare professionals
1. do not prescribe valproate medicines for epilepsy or bipolar disorder in
women and girls unless other treatments are ineffective or not tolerated;
migraine is not a licensed indication
2. ensure women and girls taking valproate medicines understand the 30 - 40%
risk of neuro-developmental disorders and 10% risk of birth defects and are
using effective contraception
The European Medicines Agency (EMA) has started a review looking at the use
of valproate-containing medicines in the treatment of women and girls who
are pregnant or of childbearing age. These medicines are approved
nationally in the European Union to treat epilepsy, bipolar disorder and in
some countries, migraine.
An EMA review in 2014 resulted in measures to strengthen the warnings
and restrictions on the use of valproate medicines
in women and girls, due to the risk of malformations and developmental
problems in babies who are exposed to valproate in the womb. The EMA is
holding its first public hearing to discuss the issue and is inviting
citizens to share their experience with valproate on September 26, 2017 in
London.
In May 2013, the U.S. FDA issued a safety alert and advised health care
professionals and women that the valproate sodium and related products,
valproic acid and divalproex sodium, are contraindicated and should not be
taken by pregnant women for the prevention of migraine headaches. Based on
evidence that these medications can cause decreased IQ scores in children
whose mothers took them while pregnant.
With regard to valproate use in pregnant women with epilepsy or bipolar
disorder, the FDA advised that valproate products should only be prescribed
if other medications are not effective in treating the condition or are otherwise
unacceptable.
With regard to women of childbearing age who are not pregnant, the FDA advised
that valproate should not be taken for any condition unless the drug is
essential to the management of the woman's medical condition. All
non-pregnant women of childbearing age taking valproate products should use
effective birth control.
It will be interesting to know the status of valproate in your country. I
will appreciate if you can please share the valproate product information
leaflet/prescribing information.
Thank you,
Rizwan
Syed Rizwanuddin Ahmad, MD, MPH, FISPE, FCP
Pharmacovigilance & Regulatory System Strengthening Consultant
Ex-Consultant/Safety Reviewer, U.S. FDA (1998-2013)
Associate Professor (adjunct), Rutgers School of Public Health, NJ, USA
Assistant Professor (adjunct), Georgetown University School of Medicine,
Washington, DC, USA
www.drugsafetyconsultant.com
Email: drugsafetyconsultant@gmail.com