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FDA Drug Classifications Fail to Protect Pregnant Women

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Pregnant women and their unborn children are particularly susceptible to the potential dangers of prescription drugs. The Food and Drug Administration (FDA) requires that drug companies label all medicines clearly to warn of the risks and side effects. Unfortunately, the information available is often incomplete, leading to a greater risk of negative side effects or birth defects. New guidelines designed to offer more details could instead cause more confusion.

FDA Pregnancy Classifications

The FDA is lacking a great deal of information about most medicines and the effects they have on unborn children. To help women make informed decisions about medications, the FDA assigns categories to medications. The safest drugs fall under category A, where there is no known risk to the fetus during the pregnancy. The FDA classifications are as follows[1]:

A – No studies have shown any risk to the fetus during pregnancy.

B – No adequate studies exist to rule out danger to the fetus. The drug may provide benefits that overrule the potential dangers.

C – Studies in animals show dangers to the fetus, but no adequate human studies exist. The drug may provide benefits that overrule the potential dangers.

D – Studies have clearly demonstrated risk to the human fetus based on real world experiences or human studies. The drug may provide benefits that overrule the potential dangers.

X – Studies clearly show a risk of fetal abnormalities in animals or humans and the potential benefits of the drug are not enough to overcome the dangers.

While these classifications protect women from known dangers, they can do little else. Another problem with the classification system lies in the vague wording that leaves them open to wide interpretation. Until a drug’s dangers become known, women and their children remain at risk.

FDA Admits Classifications are a Problem

Karen Feibus works as a medical team leader at the FDA’s office of new drugs. She admits the problem, saying, “You may have drugs with no data on reproductive toxicity at all, and drugs where a few animal offspring showed some malformations, and drugs where studies showed the frequent major malformations in three different species, and they’re all lumped together in category C.”[2]

Testing Information Complicated

To make matters worse, the literature that comes with medications describes the manufacturer’s clinical trials in scientific jargon, making them hard for many women to understand. This leaves women at the mercy of their doctors’ interpretations, instead of giving them access to easily understandable information.

Labeling Changes May Make Matters Worse

The FDA is moving away from pregnancy categories in an effort to provide clearer information, but the new rules may instead muddy the waters more. Drug labels will include summaries of known pregnancy risks with considerations doctors should take into account. This may be confusing for patients, leading pregnant women to assume a drug is safe because no human studies show a risk to the fetus.

Contact Us

If you or someone you love has a child with birth defects that may have been caused by medication, contact our office. Our attorneys understand pharmaceutical laws and can help you decide if you should file suit for damages. The first consultation is free.


[1] http://depts.washington.edu/druginfo/Formulary/Pregnancy.pdf

[2] http://online.wsj.com/article/SB10001424052748704559904576228562628352214.html

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