May 7, 2013
FDA Warns Pregnant Women Not To Use Some Migraine Medications
redOrbit Staff & Wire Reports - Your Universe Online
The US Food and Drug Administration (FDA) is warning women who are of childbearing age not to use several varieties of migraine medicine which could decrease the intelligence of their babies if taken while pregnant.
According to Reuters, the medications — Abbott Laboratories' Depacon, Depakote, Depakote CP, Depakote ER and Depakene, as well as Noven Therapeutics LLC's Stavzor and the generic versions of each drug — all contain the ingredient valproate sodium. Valproate sodium is used to help prevent the debilitating headaches, as well as to treat both epileptic seizures and the manic episodes associated with bipolar disorder.
The pills all currently include warnings associated with an increased risk of birth defects, but AP Health Writer Matthew Perrone said that the FDA opted to add the new warnings after a study showed that valproate sodium decreased the IQ scores in children whose mothers had taken them while pregnant.
“Valproate medications should never be used in pregnant women for the prevention of migraine headaches because we have even more data now that show the risks to the children outweigh any treatment benefits for this use,” Dr. Russell Katz, director of the Division of Neurology Products (DNP) in the FDA´s Center for Drug Evaluation and Research, said in a statement.
“For its other approved uses — bipolar disorder and seizures — valproate may have some value in pregnant women, but it should only be taken if other medications have not controlled the symptoms or are otherwise unacceptable,” the US health agency added. They advise all women who could become pregnant not to take the drug unless absolutely necessary, and to talk with their primary care physician immediately if they are currently using valproate.
Perrone reports that the new regulations follow a study published earlier this year by researchers at Emory University, which discovered an eight to 11 point reduction in IQ scores for affected six-year-old children. Their study compared youngsters whose mothers had taken different classes of neurological drugs while pregnant, he added, and the conclusions of their study was similar to findings recorded when the children were three-years-old.
The FDA were said that they were “working with the manufacturers to make changes to the drug labels to reflect this new information and to change the pregnancy category for prevention of migraine headaches to category X (the drug's risks outweigh the drug's benefits for this use) from category D (the drug's benefits outweigh the drug's risks for this use).” They added that the drugs will remain category D for the other approved uses.