FDA Recommends New Labeling

Posted by Brenda Lane Jun 3, 2008

If you are pregnant or breastfeeding, you are more than likely exposed to at least one type of medication prescribed by your physician or medical caregiver. Now the FDA is recommending that prescription drugs carry more comprehensive information about the effects of medications so that providers can provide more accurate and detailed information to their pregnant or breastfeeding patients.

According to the new FDA report, "The proposed rule outlines what important information about the use of medicines during pregnancy and breast-feeding would be required to be added to product labeling for newly approved drugs. Under the proposal, drug labeling would explain, based on available information, the potential benefits and risks for the mother and the fetus, and how these risks may change during the course of pregnancy."

The new proposed labeling would include three parts:

1. Fetal Risk Summary - describing known drug effects on the baby.

2. Clinical Considerations - potential effects of the drug if the mother takes it before she knows she is pregnant.

3. Data - more information on the use of the drug in human and animal studies that were used to identity the Fetal Risk Summary.

The new recommended labeling can only help women and their babies be more educated about drug effects and other potential things to avoid during pregnancy.

Brenda