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Adrianne Webb
Adrianne Webb
Attorney • (215) 825-3211

Anti-depressants and birth defects – Doctors can’t tell you what they don’t know

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When a woman finds out she’s pregnant, one of the first thoughts that goes through her mind is: what can I do to keep this baby healthy? For guidance, they look to their general practitioners and obstetricians. Doctors must rely on the information provided by the drug companies to advise their pregnant patients as to what drugs are safe to take during pregnancy.

Manufacturers are required by the FDA to give prescription drugs a pregnancy category to help doctors and mothers determine what is – and what is not – safe to take during pregnancy. Category A and B drugs are generally considered safe for use during pregnancy.

Category C drugs should only be taken if the potential benefit justifies the potential risk to the growing fetus. Category C drugs either have (1) been tested in animal studies that reveal adverse effects on the animal fetus and there are no controlled studies in women or (2) do not have studies in women and animals and the risk is unknown.

Prescription drugs in Category D pose a significant risk to a growing fetus and should only be taken when the risk to the mother for not taking the drug is worse (i.e. if a drug is needed in a threatening situation). Prescription drugs have positive evidence of human fetal risk.

In December of 2005, anti-depressant Paxil was changed from a Category C drug to a Category D drug because it caused birth defects in infants born to mothers taking Paxil while pregnant. Paxil is the only anti-depressant SSRI that has been changed to a Category D drug.

Zoloft, Lexapro, Celexa, Prozac, and other SSRI’s are still Category C drugs. This does not mean that they absolutely do not cause harm to human fetuses, it simply means that testing in humans – namely, pregnant women – has not been conducted and the risk is unknown. My question is – how can doctors truly advise their pregnant patients when a risk is unknown?