Pregnant Women Warned By FDA to Avoid Paxil

By John M Grohol PsyD
December 10, 2005

Boy, the FDA is sure confusing us these days.

One day they recommend against approval of a new medication (the ADHD patch), the next they come out and say, “Hey, it’s a-okay!” That doesn’t exactly give us the warm fuzzies when it comes to protecting the American public’s health, as they claim to be doing when they block Americans from purchasing the exact same medications from Canada (at a cheaper price).

So now, 13 years after its initial release in 1992, the FDA is suggesting that maybe Paxil isn’t exactly safe for use by women who are pregnant or expecting to get pregnant. Huh?? Isn’t one of the bars that medications are supposed to hurdle for the FDA is the big one labeled, “Safety”?

Frankly, I’m surprised and a bit aghast by this finding. Given that the majority of people prescribed Paxil are women, and a significant minority portion of those are women who are pregnant or trying to get pregnant, I’m not sure how our government could let this drug be prescribed on the market for 13 years before figuring this out.

Very disappointing.

The Food and Drug Administration warned pregnant women and their doctors away from the antidepressant Paxil yesterday because of an increased risk of heart defects in newborns.

With the warning, the agency for the first time placed a popular antidepressant — one in the same drug class as Prozac and Zoloft — into its second-highest category for risk of birth defects. The agency did not say Paxil could never be used by pregnant women, but it did say the FDA “is advising patients that this drug should usually not be taken during pregnancy.”

The advisory is based on early results from two studies, which found that women who took Paxil in the first three months of pregnancy were 1 1/2 to two times more likely to give birth to a child with a heart defect than women who took other antidepressants or pregnant women overall. The studies found that Paxil had a risk of birth defects that other common antidepressants did not.

Dr. John Grohol is the CEO and founder of Psych Central. He has been writing about online behavior, mental health and psychology issues, and the intersection of technology and psychology since 1992.