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Change to drug labelling planned


A US drugs watchdog has proposed major revisions to the physician labelling for prescription drugs.

The move by the Food and Drug Administration is an attempt to provide better information about the effects of medicines used during pregnancy and breast-feeding.

The proposed changes to prescription drug labelling would give healthcare professionals more comprehensive information for making prescribing decisions and counselling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.

Although physician labelling is directed to healthcare professionals, it is sometimes adapted for use in consumer-directed labelling such as patient package inserts or medication guides when the guidelines are approved for a prescription drug.

Rear Admiral Sandra Kweder MD, at the Centre for Drug Evaluation and Research, said: “With this proposal, FDA’s goal is to help women, their physicians and their pharmacists have better information about the effects of prescription medicines so that pregnant women, nursing mothers, and breast-feeding infants will benefit.

“This proposal would help make drug labelling a better communication tool, and would potentially have a huge impact on public health and wellbeing for women.”

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Food and Drug Administration

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