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Drug companies will have to provide clearer information to doctors about the safety of their drugs during pregnancy, the Food and Drug Administration said Wednesday.
The FDA’s replacing the old letter-based system, which characterized drugs as A,B,C,D or X for pregnant and breast-feeding women. Instead, prescription drugs will have printed inserts with detailed information on what’s known about a drug’s safety during pregnancy and breast-feeding.
The old system was far too confusing and simplistic, said the agency’s Dr. Sandra Kweder.
“This was probably one of the least informative product labeling there is,” she told reporters. “Doctors didn’t understand it.” They often had to go look up studies in medical journals to understand what effect a drug might have on a patient, Kweder said.
“We thought that it was not right that clinicians should have to go to other sources, other than the drug label,” she said.
The rule does not apply to over-the-counter drugs, and takes effect at the end of June 2015. The FDA says U.S. women take an average of three to five prescription drugs while pregnant.