Medication Decisions in Pregnancy Clarified, and Continually Updated

Many pregnant women have difficult decisions to make with regard to medications they need to use when pregnant. Medication dosage and effects often change with pregnancy, and there is the question of whether the medication will cross the placenta into the baby, and if so what effects that might cause. Rather than broad categories of risk, the FDA now recommends specific information be given about the known effects of medications in pregnancy and during lactation. A new FDA rule eliminated what used to be the "A,B,C,D,X" categorization. Now the drug descriptions will summarize the risks in humans, animals, and laboratory pharmacological studies during pregnancy. If the drug is not absorbed through the system, it will be labeled as such. Any known effects on breast tmilk, or effects in children will also be given. The labeling will also include when and if pregnancy testing should be done when on the medication. The new information in the label will include recommendations for males as well. The labels will also be updated as new information becomes available. Medications approved after 6/30/2005 will be updated first, older medications have a longer time to comply with the rules and we will see a phasing in of labels.


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