FDA to study safety of drugs taken during pregnancy

U.S. health officials plan to study the safety of medications taken during pregnancy with an eye toward using the data in future regulations and medical practice, the U.S. Food and Drug Administration said on Wednesday.

Citing a lack of clinical trials to determine how medications affect mothers and unborn children, the FDA said it will collaborate with other researchers in the new study, called the Medication Exposure in Pregnancy Risk Evaluation Program.

The agency said data shows that about two-thirds of women who deliver a baby have taken at least one prescription medication during pregnancy.

“Results of these studies will provide valuable information for patients and physicians when making decisions about medication during pregnancy,” Gerald Dal Pan, a director at the FDA’s Center for Drug Evaluation and Research, said in a statement.

The program will work off of data from 11 health plan-affiliated research sites that have healthcare information for about 1 million births over a seven-year period started in 2001.

The FDA did not give a timeline for when the program will complete the safety study.

WASHINGTON (Reuters)