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Monday, June 09, 2008

Better Labels for Prescription Drugs

FDA Proposes New Drug Labels for Pregnant Women.

From the article:
Under the new proposal, drug labeling would explain the potential benefits and risks for the mother, her fetus or her new baby, and how these risks change over the course of pregnancy, Kweder said.
New drug labels would include three sections devoted to pregnancy and breast-feeding. The first section, called the "Fetal Risk Summary," would describe what's known about the effects
of a drug on the fetus and whether the risk is based on results of animal studies or human studies.
The second section, called "Clinical Considerations," would include information about effects associated with the drug if it were taken before a woman knows she is pregnant. This section would also outline risks of the disease to the mother and baby, dosing information and how to address complications.
The final section, called "Data," would describe in detail the available information about the drug's use in humans and
animals studies used in developing the "Fetal Risk Summary."
The breast-feeding section of the label would use the same format as the pregnancy section and provide information about using the drug while nursing, Kweder said.

You can also find information about drug safety during pregnancy and breastfeeding from KellyMom and from the book Medications and Mother's Milk. Remember, even if a medication that you are prescribed is unsafe for breastfeeding, you can still talk with your doctor about a possible alternative drug that would be safe for while you are nursing.
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