Time for Pharma to Deliver?
For the vast majority of pharmaceutical products, data on safety for pregnant and lactating women and their fetuses and babies is not available. But going without essential medication is not the right solution – failing to treat health conditions could lead to equal or increased risk for mother and child. Here, we seek the path to a more enlightened approach.
Roisin McGuigan |
The adequate inclusion of women in clinical trials is an issue with an increasing level of awareness – and it’s a topic The Medicine Maker has covered previously (1)(2). But there is one particular group of women who continue to be far more underserved by clinical research: pregnant women.
And there’s a good reason the problem should not be ignored: according to the FDA, half of pregnant women report taking at least one medicine (3). Worrying then that, of the 172 drugs approved by the FDA between 2000 and 2010, 97 percent had an “undetermined” risk for pregnancy. Perhaps worse, for 73 percent of new drugs the amount of data available on safety in pregnancy was rated as “none” (4). Every day, pregnant women need to make decisions and balance the risks to their own and their unborn children’s health when deciding to take – or not to take – medications for which no clear guidance is available. Often, the health care professionals advising them can’t offer much help either, for the same reason: the data they need simply doesn’t exist.
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