FDA To Require Better Labeling On Meds For Pregnant Women

FDA To Require Better Labeling On Meds For Pregnant Women

NEW HYDE PARK, NY – New FDA regulations will do away with alphabet-coded risk categories on labels of medications for pregnant women and those who are breastfeeding and provide more detailed information.  That’s a welcome relief to one New York high-risk pregnancy specialist who said the labels provided limited and confusing information for physicians on their effects for patients.

“The alphabet system was developed to simplify thinking about these medications, but it’s made it much more complicated because physicians looked at the categories of only A and B as those that can be used during pregnancy because they demonstrated no risk to the fetus,” said Natalie Meirowitz, MD, chief of Maternal/Fetal Medicine at Long Island Jewish Medical Center.

“But, In fact, a category C or D medication may be safe to use in pregnancy but there was just limited data on them,” said Dr. Meirowitz.  “Some of the most common medications that we use during pregnancy are category C medications, such the alubuterol inhaler that’s used for asthma.”

According to the FDA, the revamping of labels was necessary because:

  • Women take three to five medications during pregnancy.
  • Pregnant women could have chronic conditions – such as asthma, high blood pressure, depression and diabetes – that require them to continue taking the medications they started before becoming pregnant.
  • New health problems may arise or old ones may worsen during pregnancy, requiring treatment.
  • A woman’s body changes throughout her pregnancy, which can affect her medication dosage needs.

The revised labeling will also include more information on whether medication gets into breast milk, and how it can possibly affect the infant.

Topics: News

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