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Research Links Depakote to Birth Defects

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Boston, MAFor women who suffer from seizures, the question of whether or not to take Depakote and risk Depakote birth defects might be more straightforward than with other medications. Studies have suggested a risk of serious Depakote side effects in babies exposed to Depakote prior to birth, leading researchers and the US Food and Drug Administration to recommend women not take Depakote if they could become pregnant.

According to one study, which analyzed more than 98,000 pregnancies, babies who were exposed to Depakote during the first trimester had 12 times the risk of being born with spinal bifida than babies not exposed to the medication. The study, published in the June 10 issue of the New England Journal of Medicine also found five more birth defects associated with the use of Depakote while pregnant.

Those birth defects include increased risk of atrial septal defect, cleft palate, hypospadias (where the opening of the urethra in boys is on the underside of the penis or on the scrotum), craniosynostosis (where the skull bones close too early) and polydactyly (where the infant has more than five fingers per hand). Risks of those birth defects increased by two times up to seven times compared with babies who were not exposed to Depakote.

Researchers noted that the absolute risk of developing those conditions was low, between 0.1 percent and 0.7 percent. They also noted that the study could not prove Depakote caused the birth defects, just that it was associated with them.

The findings led researchers to recommend against using Depakote (known generically as valproic acid) during pregnancy.

Meanwhile, a more recent study suggests a link between the use of Depakote and other epilepsy medications when pregnant and lower academic scores. The study, published online November 4 in Epilepsia, found that teens who were exposed to two or more epilepsy medications before birth received lower scores in multiple school subjects than teens not exposed to epilepsy medications.

Like the previous study, the study examining academics cannot prove that epileptic medications caused the lower academic scores, only that there is a link between the use of the medications and lowered scores. There could be other social and genetic factors that play a role in those students receiving lower scores on academic subjects.

The FDA has recommended that women who could become pregnant should only use valproate if necessary to manage their medical condition. Women who are pregnant or plan on becoming pregnant, however, should not discontinue their medication without speaking to a medical professional, as there are risks to having uncontrolled seizures.

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READER COMMENTS

Posted by

on
Is Depakote the same as Epilim which is known as Sodium Valproate and produced and distributed by Sanofi-Aventis. If it is the same product then for your information there is a litigation currently in the UK involving 100 children with fetal valproate syndrome. My son is one of the claimants. If any parents would like help or support dealing with Fetal anti convulsant syndrome please contact www.oacs-uk.co.uk
Best wishes to all
For more info check out these links.

Twitter: @emmafriedmann

http://www.guardian.co.uk/society/2010/nov/08/legal-aid-anti-epilepsy-drug
*http://www.guardian.co.uk/law/2010/nov/29/epilim-legal-aid-flaws
http://www.bbc.co.uk/news/uk-11707386
http://www.bexleytimes.co.uk/news/erith_and_thamesmead_mp_campaigns_to_overturn_decision_to_withdraw_legal_aid_in_landmark_case_1_737181
*http://www.thisisleicestershire.co.uk/health/Cash-blow-birth-defects-case/article-2900744-detail/article.html
http://www.newsandstar.co.uk/news/cumbrian-woman-pledges-to-fight-on-for-daughter-despite-legal-aid-setback-1.785097?referrerPath=home
*http://www.thisisleicestershire.co.uk/news/Petition-handed-PM-drugs-fight/article-2980049-detail/article.html
http://www.thisislondon.co.uk/standard/article-23906206-mothers-plea-to-david-cameron-help-us-win-payout-for-our-disabled-girl.do
http://menmedia.co.uk/prestwichadvertiser/news/s/1388554_mum_takes_drug_fight_to_downing_street
http://www.oldham-chronicle.co.uk/news-features/8/news/27638/mums-brave-battle-against-drug-giants
*http://www.bbc.co.uk/iplayer/episode/p00cg5z7/Ben_Jackson_07_12_2010/ - 1:38 into broadcast
*Monday 08/11/10 BBC Radio 4 – World at One – Martha Carney
*Monday 15/11/10 BBC Radio Leicester – Live feed on Tony Wadsworth morning show.
*Monday 15/11/10 Channel 4 News – Parents walking into Royal Courts of Justice.
*Wednesday 10/11/10 BBC Radio Leicester Breakfast Show – Eloise Henderson
*Wednesday 10/11/10 Central ITV news at 18.00 - Gareth Owen
*Thursday 11/11/10 BBC East midlands today news 13.30, 18.30, 22.30 – Rob Sissions

http://www.theoneclickgroup.co.uk/news.php?start=4220&end=4240&view=yes&id=5625#newspost
http://www.techwatch.co.uk/2010/11/08/legal-aid-withdrawn-in-epilim-fight/
http://topnews.co.uk/216286-govt-withdraws-financial-support-epilim-case-likely-be-abandoned
http://topnews.ae/content/24795-epilim-case-likely-be-dropped
http://www.goodmanslaw.co.uk/blog/epilim-access-to-justice-
http://web.me.com/stevescrutton/Banned_Pharma_Drugs/Epilim.html
http://www.newscientist.com/article/dn6532-epilepsy-drug-may-harm-fetal-development.html
http://www.thesun.co.uk/sol/homepage/news/article855922.ece
http://www.alexanderharris.co.uk/News/ClinicalDentalNegligence/Pages/AdversereactionstoepilepsydrugEpilim-casefacescutoffpoint.aspx
http://www.thepharmaletter.com/file/99688/uk-families-denied-legal-aid-for-epilepsy-drug-sodium-valproate-court-case-against-sanofi-aventis.html
http://www.coping-with-epilepsy.com/forums/f23/uk-class-action-lawsuit-over-sodium-valproate-birth-defects-733/
http://www.reuters.com/article/idUSL138575120081201
http://rowlands.maars.net/?p=6837

http://wn.com/HELENOR_-Victim_of_EPILIM_Valproate-plus_Body_Parts_-pt_3
http://article.wn.com/view/2010/11/08/Legal_aid_withdrawn_from_epilepsy_drug_families/
http://article.wn.com/view/2009/04/15/Epilepsy_drug_Depakote_in_pregnancy_linked_to_lower_IQ_in_ki/

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