The big shift in thinking about antidepressant use in pregnancy began in late 2005, when the FDA warned that Paxil “increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy,” and demanded GlaxoSmithKline to change Paxil from a “Category C” drug to a “Category D” drug, i.e. a drug known to produce birth defects or injure fetuses.
In February 2006, the landmark “Selective Serotonin-Reuptake Inhibitors and Risk of Persistent Pulmonary Hypertension of the Newborn (PPHN)” study was published in the New England Journal of Medicine, showing that Prozac use in the third trimester of pregnancy increased the risk of PPHN. That study prompted the first formal SSRI FDA warning in July 2006 across the board for Celexa, Lexapro, Paxil, Prozac and Zoloft. In 2009, the British Medical Journal showed Prozac, Celexa, Paxil and Zoloft were all associated with an increased risk of congenital heart defects, particularly if a pregnant woman used more than one. In January 2012, the British Medical Journal reviewed over 30,000 pregnancies involving SSRI use and found the risk of PPHN was doubled when the baby’s mother used an SSRI. Just a week ago, the Archives of General Psychiatry published a study concluding that pregnant mothers treated with SSRIs had higher rates of premature birth and delayed infant head growth.
The risk is there, and the body of scientific research is growing, but many patients still don’t know the risks of using SSRIs in pregnancy, and today more than 5% of pregnant women take antidepressants. Other than changing the birth defect risk category of Paxil, though, the FDA hasn’t done anything to fix the situation. In December 2011 the FDA issued a drug safety communication that frustratingly said “it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN.” Zoloft, Lexapro, Celexa, and Prozac are still listed as a Category C drugs, and none of them warn patients or doctors about the risk. Buried in the fine print of Prozac’s warning label there’s a reference to PPHN and congenital heart defects, but then the risk is dismissed: “There are no adequate and well-controlled clinical studies on the use of fluoxetine in pregnant women.” Zoloft’s warning label doesn’t even mention the possibility of birth defects except through a vague reference to studies of pregnant rats.
All told, birth defect lawyers have probably done more to educate the public about the dangers of SSRI use in pregnancy by way of television ads than the FDA has. Which brings me to the core of this post: the increasing role of the First Amendment in drug liability lawsuits.