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New drug labeling system to help pregnant women

New drug labeling system to help pregnant women



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Dr. Kim Mulvihill reportingWomen who are breastfeeding, pregnant or thinking about it have to be very careful about the medications they take. Now, new labels should make it easier for them.

When a pregnant woman is prescribed a medication, she usually asks if the drug will hurt the baby. The current system used by doctors and pharmacists uses letters to convey degrees of danger: A, B, C, D and X. A is the safest, and X is the most hazardous.

Now, the FDA says this 30-year-old system is confusing, inaccurate and needs an overhaul. The idea is to have new labels with a vast array of information, kind of like one-stop shopping.

Each drug label will have two categories: one for pregnancy, the other for breastfeeding. Under each category, the patient can find all the information available about the drug; from its effect on the fetus or newborn to clinical considerations if, for example, the mother stops taking the medication.

The old system was designed just for use in pregnancy. The new system takes into account a stark reality: Pregnant women take on average three to five prescription drugs.

Not only that, but many women use prescription drugs unaware they're already pregnant. In fact in the United States, of 6 million pregnancies each year, half of these are unplanned.

The proposed rule now faces 90 days of public comment. After that, the FDA will finalize it and it goes into effect.

All prescription drug labels will have to change. New drugs will just come to market with the new labels, and existing drugs will be given time, a few years, to phase in these new labels.

E-mail: drkim@ksl.com

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