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New US drug labelling practices

New rules are being put forward in the US that could require pharmaceutical companies to provide more in-depth label information
New rules are being put forward in the US that could require pharmaceutical companies to provide more in-depth label information about the effect of drugs on women who are pregnant or breastfeeding.

The US Food and Drug Administration (FDA) has proposed major revisions to the way in which drug manufacturers label medicinal products. Any changes in labelling practices are being aimed at increasing the amount of information available to healthcare professionals for issuing advice and prescriptions to pregnant women.

"FDA's goal is to help women, their physicians and their pharmacists have better information about the effects of prescription medicines," said Rear Admiral Dr Sandra Kweder, at the FDA Centre for Drug Evaluation and Research.

"This proposal would help make drug labelling a better communication tool and would potentially have a huge impact on public health and well being for women."

On average, expectant women in the US take between three to five prescription drugs during their pregnancy. Some women may need to continue with a course of medication needed for long-term problems, such as asthma or hypertension.

The FDA began exploring ways to improve drug labelling in the 1990s after determining that information included on labels about pregnancy and breastfeeding was insufficient. Stakeholders have said that the current letter category system being used often leads to inaccurate and over simplified details about the effects of medicines on pregnant women.

29th May 2008

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