The Food and Drug Administration recently put out a warning that the drug Depakote, known generically as divalproex sodium, taken during pregnancy may cause brain damage that could lower the child’s IQ by as much as 11 points, on average. The drug, which is prescribed to treat seizures, bipolar disorder and chronic migraines, already carries a warning that it contains sodium valproate, which is known to be associated with birth defects, but the FDA has gone a step beyond that warning now.
If you’re pregnant and take Depakote, talk to your doctor and stop taking it. If you’re of childbearing age and take Depakote, get on reliable birth control.
The agency has changed the classification of the drug from Category D — drugs with potential risks which are still considered acceptable — to Category X, meaning that the known risks of the drug outweigh the benefits.
To put that reclassification in perspective, the 1950s drug Thalidomide, which caused birth defects in more than 10,000 babies during the five years it was prescribed to treat pregnancy-related nausea, is classified as Category X.
“When babies are growing rapidly and the brain is growing rapidly, a change in how much blood flow is going to one part versus another could easily impact development long-term,” one obstetrician explained.
Unfortunately, Depakote is one of the most popular medicines prescribed to prevent and treat chronic migraines. Fortunately, there are other options that won’t cause infant brain damage. “There are several other medicinal choices,” another doctor told reporters, “and usually, we can find another choice for someone that will at least help them decrease the frequency and severity of their migraines.”
The FDA’s primary warning was that the risk of infant brain damage from Depakote outweighs the benefits for migraine treatment. For those who take the drug for bipolar or seizure disorders, a serious discussion with a doctor is still in order if they may become pregnant. There may be no safe amount of time to take Depakote while you’re pregnant.
In any case, the FDA’s reclassification of the drug to Category X should cause many to reconsider the risk. The reclassification is also likely to mean that insurance companies will no longer routinely pay for the drug.
“No parent, no mother would want to take a drug that lowered her child’s IQ knowingly,” said the second doctor. “I think that is a big deal.”
Source: KMSP-TV, “FDA warns migraine medicine Depakote may lower child’s IQ,” Bill Keller, May 6, 2013