Most pregnant women wind up taking at least one prescription drug. But, because no one wants to subject pregnant women and their unborn children to a clinical trial, there’s very little clear evidence about the unique risks some prescription drugs may pose during pregnancy.
So the FDA is funding an analysis of data on prescription drug use and pregnancy outcomes from a bunch of health systems that collectively recorded roughly one million births between 2001 and 2007. Researchers from Harvard, Vanderbilt and Kaiser Permanente, among others, will work on the project.
In the current system, women and their doctors rely in part on letters the FDA assigns to prescription drugs as a shorthand for what is known about a drug’s effect on pregnant women and their babies. The letters are explained here. A 2004 study published in the American Journal of Obstetrics and Gynecology found that more than a third of pregnant women take prescription drugs from category C, which means the effects on human fetuses are unknown.
The FDA described the new reserach project in a statement yesterday, but didn’t say when it expects results from the analysis.
Hat Tip: Pharmalot; Image: iStockphoto