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21/04/2017
The study, by France's National Agency for the Safety of Medicines (ANSM), found that women who are treated with valproate for epilepsy were up to four times more likely to give birth to a malformed child.
The report claims that between 2,150 and 4,100 children suffered severe malformations linked to the drug. Types of birth defects attributed to the drug include spina bifida, and defects of the heart and genital organs. There was also found to be a higher risk of autism and developmental problems. These will be explored in more detail in a follow-up report due later this year, it is understood.
The study also found that while women treated for bipolar disorder were at a lower risk than those treated for epilepsy, they were still twice as likely to give birth to children with major birth defects.
The drug, which is prescribed worldwide, was introduced in France in 1967. Now, doctors in the country are now advised not to give it to girls, women of childbearing age, and pregnant women.
Earlier this month, the NHS in the UK also issued an alert over the drug. It said that valproate – which is also marketed as Epilim, Depakine, Depakote and Stavzor among other names – should only be given to girls and women of childbearing age under specialist supervision and only when other medications had been found not to work.
(JP/MH)
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Pregnant Women Warned Over Use Of Epilepsy Drug
A new study has suggested that a drug given to pregnant women for epilepsy and bipolar disorder has caused "serious malformations" in thousands of children.The study, by France's National Agency for the Safety of Medicines (ANSM), found that women who are treated with valproate for epilepsy were up to four times more likely to give birth to a malformed child.
The report claims that between 2,150 and 4,100 children suffered severe malformations linked to the drug. Types of birth defects attributed to the drug include spina bifida, and defects of the heart and genital organs. There was also found to be a higher risk of autism and developmental problems. These will be explored in more detail in a follow-up report due later this year, it is understood.
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The study also found that while women treated for bipolar disorder were at a lower risk than those treated for epilepsy, they were still twice as likely to give birth to children with major birth defects.
The drug, which is prescribed worldwide, was introduced in France in 1967. Now, doctors in the country are now advised not to give it to girls, women of childbearing age, and pregnant women.
Earlier this month, the NHS in the UK also issued an alert over the drug. It said that valproate – which is also marketed as Epilim, Depakine, Depakote and Stavzor among other names – should only be given to girls and women of childbearing age under specialist supervision and only when other medications had been found not to work.
(JP/MH)
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