FDA Proposes New Drug Labels for Pregnancy Effects

The Food and Drug Administration proposed changes to drug labels warning about the effects of the drug for pregnant and breastfeeding women this week. The current system of coded letters (A, B, C, D and X with A meaning extremely low risk to a fetus or infant and X meaning high risk) has been deemed overly simplistic, confusing and inaccurate, according to the Wall Street Journal.

The new system proposed by the FDA would include three sections for pregnancy in the label: Fetal Risk Summary, Clinical Considerations, Data (information from studied involving the drug), according to a FDA press release. Another section on the effects for breastfeeding would also be included.

There are approximately six million pregnancies per year in the US, and pregnant women take an average of three to five prescriptions during their pregnancy, reports the Associated Press. The proposed changes are open for public comment for 90 days before the FDA makes a final decision.


Wall Street Journal 5/29/08; FDA press release 5/28/08; Associated Press 5/28/08

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