France: 450 cases of birth defects from Sanofis anti-epilepsy drug
Advertisement
Paris: 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.
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 1, 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 10 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.
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 1, 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 10 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.
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.