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FDA Wants New Drug Labels for Pregnant, Nursing Moms

Dr. Andrew C. von Eschenbach described women who are pregnant or nursing as a population with “very, very special needs.”  These words spoken as von Eschenbach, commissioner for the US Food and Drug Administration (FDA), hosted a press conference earlier today to announce a proposed change to the drug labeling system currently in place.

The new labeling system, as proposed, will expand the current letter-based system, which places each medication in a risk category designated by the letters A, B, C, D, or X.  Under the new labeling system, a category will be added to designate medications that might pose risk to pregnant women and a separate one will identify medications that might pose risk to women who are nursing.

According to FDA data, pregnant women, on average, take between three and five separate prescription drugs during pregnancy.  Even though the proposed labeling system is thought to be confusing or just not useful to some critics, advocates of the change say the more informative labels will help protect the health of mother and child when prescription medications are needed during pregnancy or lactation.

The value of the labels is questioned by other critics because drugs are rarely tested on pregnant women and those nursing because of ethical issues and the very high, very real risk of unanticipated consequences.

The FDA expects negotiations made in the next 90 days will determine the final recommendations on drug labeling for pregnant and nursing women.  The agency expects the new labeling laws to become effective no sooner than June 30, 2010.

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