For years, cautious pregnant women and their obstetricians thought the most safe approach to taking any medication more potent than a cough drop was to avoid it altogether. But abandoning treatment for chronic health conditions, such as depression, asthma or diabetes, can sometimes affect the baby more than taking a medication while pregnant, experts said.
To help doctors and patients weigh the risks and benefits of taking medications during pregnancy and breast-feeding, the Food and Drug Administration in June will require a new labeling system for prescription drugs.
The revisions to prescription guidelines, which will be the first since 1979, will provide more up-to-date and specific information to doctors to help them identify the safest treatment options for common conditions during pregnancy, said Dr. Katherine Wisner, a professor and psychiatrist at Northwestern University Feinberg School of Medicine who specializes in maternal mood disorders.
The updated prescribing guidelines consist of three components. The first gives physicians information on dosing and risks to the fetus. It also indicates whether data has been collected to show the drug's effects, which is something never required until now. The second states what is known about the drug's impact on breast-feeding, and the final section addresses how the product may affect fertility.
Some drugmakers have already phased in the changes, while the deadline is June 30. While consumers won't see new labels on pill bottles or bags, doctors will have more data to discuss with them.
"It's more about laying out the information for health care professionals so they are in a better position to help their patients make these decisions," an FDA spokesperson said. "That's why the most important thing is for women to still have conversations with their doctors."
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