Product News and Recalls

FDA releases warning about migraine treatment

CBS News reports on a U.S. Food and Drug Administration warning that medications containing valproate sodium may cause lower IQs in children born to women who take them.

An agency news release quotes Dr. Russell Katz, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, as saying: “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.”

According to the CBS News story, products under the warning include valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor) and their generics. Valproate medications are approved to prevent migraine headaches, treat epilepsy and treat manic episodes associated with bipolar disorder, the story says.

The FDA announced plans to change valproate products’ designation for pregnant women who take the medication for migraines. It’s presently listed as category D, meaning the benefits may outweigh the drug’s risks. It will go to category X, meaning the risks outweigh the benefits.

But the agency will keep valproate classified as category D for its anti-epileptic indications and for treatment of manic episodes, the story says.

In addition, the FDA now cautions that women who may become pregnant should not use the product unless it is vital to controlling their medical conditions, and only if there is no other alternative.

See the story here:

http://www.cbsnews.com/8301-204_162-57583081/fda-pregnant-women-taking-valproate-for-migraines-risk-childs-iq/

See the FDA warning here:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350868.htm?source=govdelivery