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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

2011 – Birth defect risk “significantly higher” with Depacon, Depakene, or Depakote exposure before birth

Posted in Depacon / Depakene / Depakote

In July, 2011, Lancet Neurology published an article titled “Dose-dependent risk of malformations with antiepileptic drugs: an analysis of data from the EURAP epilepsy and pregnancy registry.” that was written by a team from Stockholm led by T. Tomson.  This study is yet another example of peer-reviewed research demonstrating that serious risks are posed to children whose mothers used antiepileptic drugs containing valproate (Depakote, Depakene, Depacon, etc.) during pregnancy.

Tomson et al. open by writing simply “Prenatal exposure to antiepileptic drugs is associated with a greater risk of major congenital malformations, but there is inadequate information on the comparative teratogenicity of individual antiepileptic drugs and the association with dose.”  As such, the team “aimed to establish the risks of major congenital malformations after monotherapy exposure to four major antiepileptic drugs at different doses.”  That is, the team wanted to find the risk for birth defects linked to drugs individually.

Using data from the EURAP epilepsy and pregnancy registry (“an observational cohort study representing a collaboration of physicians from 42 countries”), Tomson “assessed rates of major congenital malformations in 1402 pregnancies exposed to carbamazepine, 1280 on lamotrigine, 1010 on valproic acid, and 217 on phenobarbital.”  (Valproic acid is another form of valproate, identical in biochemical effect.)

The team found “An increase in malformation rates with increasing dose at the time of conception was recorded for all drugs. Multivariable analysis including ten covariates in addition to treatment with antiepileptic drugs showed that the risk of malformations was greater with a parental history of major congenital malformations (odds ratio 4·4, 95% CI 2·06-9·23).”

“Compared with lamotrigine monotherapy at doses less than 300 mg per day, risks of malformation were significantly higher with valproic acid and phenobarbital at all investigated doses, and with carbamazepine at doses greater than 400 mg per day.”

Because thousands of women around the world have used Depacon, Depakene, and Depakote while pregnant unaware of the increased risk for birth defects associated therein, Depacon birth defect lawsuits have been filed in great number.

If you or a loved one used Depacon, Depakote, or Depakene during pregnancy and your child was born with a birth defect, your family may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Depacon birth defect lawyers at the information provided below.  We have the experience, compassion, and resources required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5528

justinian@dangerousdrugs.us

Our Depacon Lawsuit Information page is a great place to start if you have any questions about Depacon.