Cites Higher Risks Of Neural Tube Defects Like Spina Bifida, Hypospadias, And Other Birth Defects As Well As Increased Risk Of Autism Spectrum Disorder

(Posted by Tom Lamb at DrugInjuryWatch.com)

More restrictions of the use of valproate drugs — such as Depakote, as well as Depakene and Depacon, from AbbVie Inc. (formerly Abbott) — by women who may become pregnant have been recommended by a European drug regulatory committee.

From an October 14, 2014 Medscape news report, "Restrict Valproate, EMA Committee Urges":

The European Medicine Agency (EMA)'s Pharmacovigilance and Risk Assessment Committee has recommended strengthening the restrictions on the use of valproate in women of childbearing age.

This is because of the risk for malformations and developmental problems in children exposed to valproate during pregnancy.

The committee recommends that valproate not be used to treat epilepsy or bipolar disorder in girls and women who are pregnant or who can become pregnant unless other treatments are ineffective or not tolerated….

The recommendations of the committee will now be sent the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human, which will adopt a final position. In the meantime, women currently taking valproate who have any questions about their treatment should speak with their doctor, the EMA says.

The review of valproate was started in October 2013 after the publication of new data on the risks of valproate exposure in the womb.

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We have written several articles about the birth defects or congenital malformations and developmental problems that have been associated with Depakote, Depakote CP, and Depakote ER (divalproex sodium), Depacon (valproate sodium), and Depakene (valproic acid).

• Significantly Increased Risk Of Autism Spectrum Disorder (ASD) In Children Whose Mothers Used Depacon / Depakene / Depakote During Their Pregnancy
• Higher Risks Of Birth Defects Spina Bifida And Hypospadias Found To Be Dose-Related For Depacon / Depakene / Depakote / Stavzor
• Depacon / Depakene / Depakote: 400% Increased Risk Of Birth Defects Compared To Other Anti-Seizure Medications Used By Mothers With Epilepsy
• Depakote Or Depakene Taken During Pregnancy May Cause Congenital Malformations Or Birth Defects Such As Neural Tube Defects Like Spina Bifida
• Anti-Epileptic Drugs Associated With Birth Defects And Fetal Death

We will continue to monitor the safety profile of these valproate medications for seizures, epilepsy, bipolar disorder, and (until recently) migraine headaches. 

In addition, we are investigating possible drug injury legal cases against the responsible drug company AbbVie Inc. (formerly Abbott).

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