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Should pregnant women be included in clinical trials?

Researchers suggest mums-to-be be part of medical trials to confirm safety of drugs

Posted: 18 June 2010
by Kimberley Smith
Dosages for mums-to-be may need to be altered to account for their growing baby

The idea sounds worrying but three researchers from the US Food and Drug Administration (FDA) have suggested that it is imperative that pregnant women be included in trials of new drugs and dosage levels.

The opinion piece, published in the New England Journal of Medicine, used the Swine Flu epidemic as an example of why “it is not only permissible but also imperative that pregnant women be included in research”.

During the pandemic, many pregnant women may have been vulnerable to complications as they received a precautionary lower dosage of the drug Tamiflu because of their pregnancy.

As 64% of pregnant women are already on prescription medications, it would seem sensible to ensure the safety of future drugs and the dosage needed for them to be effective.

“Excluding pregnant women from most trials and studies is ethically and medically unacceptable for two reasons. Pregnant women get sick and sick women get pregnant,” explained an editorial from Nature science journal.

However, the real debate must be how it is possible to study the effects of drugs on mums-to-be without putting them or their baby at risk.

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drugs in pregnancy, medical trials, medical trials included in medical trials, medicines for pregnant women, pregnancy, tamiflu

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