FDA Announces Program to Study Prescription Drugs in Pregnancy

By Rachel Walden — January 4, 2010

Last week, the U.S. Food and Drug Administration announced the creation of a new research program, dubbed the “Medication Exposure in Pregnancy Risk Evaluation Program” (MEPREP), to study the effects of prescription drugs used during pregnancy.

In explaining the need for such research funding and initiatives, the agency states:

About two-thirds of women who deliver a baby have taken at least one prescription medication during pregnancy according to a journal article published in the American Journal of Obstetrics and Gynecology. There are very few clinical trials that test the safety of medications in pregnancy due to concerns about the health of the mother and child.

In order to gather such information, the FDA will collaborate with researchers to analyze data on prescription drug use and pregnancy outcomes from 11 sites of the HMO Research Network Center for Education and Research in Therapeutics, Kaiser Permanente’s multiple research centers, and Vanderbilt University (this blogger’s larger workplace).

The National Women’s Health Information Center provides further information on the use of prescription and OTC medications in pregnancy, including the current labeling categories applied to prescription drugs to indicate what is known about using them during pregnancy.

In 2008, the FDA proposed a rule change that would eliminate these somewhat unhelpful letter categories (A, B, C, D, and X) in favor of adding a “Pregnancy” section to drug labels with a risk summary and more clear information about available data on use of the drug during pregnancy and breastfeeding. A public comment period was held on the proposed rule, but it does not appear to have been finalized yet.

See also: Strollerderby post on the announced drug studies; the FDA’s info for consumers on the proposed labeling change; LactMed (search for information on specific drugs and breastfeeding); fact sheets on drug exposures during pregnancy and lactation from the Organization of Teratology Information Specialists; and Motherisk’s publications on drugs in pregnancy.

2 responses to “FDA Announces Program to Study Prescription Drugs in Pregnancy”

  1. Wow, 2/3rds is a high percentage of pregnant moms on prescription meds. I see how easily it can happen though–an allergy medicine here, an antibiotic there.

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