Pregnancy Labeling Needs Clearer, More Consistent Language, US FDA Panel Says

Language used to describe drug effects on pregnancy and lactation is ambiguous, complex and not useful to prescribers, advisors say, also urging FDA to use graphics or rating scales to convey the strength of the animal and human data on use during pregnancy.

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The US FDA should use more consistent language, as well as graphics or rating systems, to convey information about drug effects during pregnancy and lactation in product labeling, advisory committee members said March 6.

The agency's Risk Communication Advisory Committee suggested the agency needs to rethink its application of the December 2014 Pregnancy and...

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