Pregnant women given unsafe medications, study says

AORN Journal,  Jan, 2005  

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Nearly 50% of pregnant women who receive medications other than vitamins may be taking medications that the US Food and Drug Administration (FDA) classifies as having no human evidence of safety for use during pregnancy or that evidence has shown can harm a developing fetus, according to a Sept 8, 2004, news release from the Agency for Healthcare Research and Quality. In the largest study to date to examine the prescription medication use of women during pregnancy, researchers reviewed data from eight health maintenance organizations in diverse geographic areas. They evaluated prescription medication use by 152,531 women who delivered an infant in a hospital from Jan 1, 1996, through Dec 31, 2000, based on the FDA's risk classification system of medications during pregnancy. The study did not review the use of over-the-counter medications or medications prescribed in hospitals.

Researchers found that 64% of women were dispensed a medication other than a vitamin or mineral supplement within the 270 days before delivery. Of those, nearly 40% of women were dispensed a medication for which human safety has not been established (ie, category C on the FDA's list). Nearly 5% were dispensed category D medications, which the FDA classifies as having positive evidence of fetal risk, but benefits of use may be acceptable despite the risk. An additional 5% of women were dispensed a category X medication, for which evidence has found definite fetal risks based on human or animal studies or based on human experience, and risk of using the medication clearly outweighs any possible benefit.

The other approximately 50% of prescriptions were classified as category A (ie, risk to the fetus is remote) and category B (ie, animal studies do not show fetal risk, and there are no controlled studies in women, or animal studies show risk, but controlled studies in women fail to show risk). Researchers conclude that routine medication audits and physician education, as well as new technologies, such as computerized prescription systems with clinical supports, may have the potential to reduce inappropriate prescribing for pregnant women.

New Study Estimates That Some Pregnant Women Are Prescribed Drugs Which May Be Considered Unsafe During Pregnancy (news release: Rockville, Md: Agency for Healthcare Research and Quality, Sept 8, 2004) http://www.ahrq.gov/news/press/pr2OO4/pregdrugpr.htm (accessed 13 Sept 2004).

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