Possible Painkiller Link to Birth Defects
Study Shows NSAIDs May Up Risk of Heart Birth Defects During Early Pregnancy
The Study continued...
The researchers did not include women who used aspirin, Indocin, and Arthrotec. They did have information on why NSAIDs were prescribed or the use of over-the-counter NSAIDs by the women.
Francis Sullivan, a spokesman for Wyeth Consumer Healthcare -- the maker of Advil -- tells WebMD that the "study is based on prescription and not over-the-counter doses."
No significant risk for birth defects associated with other major organ systems was seen in the study, published in the September issue of the journal Birth Defects Research (Part B).
NSAIDs are generally not recommended as the first-line pain reliever of choice during pregnancybecause their use late in pregnancy is believed to increase the risk for another type of birth defect, Green says.
Instead, most ob-gyn's recommend that their patients take the pain reliever acetaminophen, such as Tylenol or a generic version of the drug.
Margaret Honein, PhD, MPH, an epidemiologist with the CDC's National Center on Birth Defects and Developmental Disabilities, says it is clear that more research is needed to determine the safety profile of NSAIDs and many other drugs during pregnancy.
"In general, we know less than we would like to know about most medications, both prescription and over-the-counter," Honein tells WebMD. "Pregnant women and breastfeedingwomen are usually excluded from clinical trials, so we often understand very little about a drug's impact during pregnancy when it reaches the market."
Honein and CDC colleagues have interviewed 24,000 mothers who gave birth to babies with birth defects since 1998 in an effort to learn more about the causes of congenital abnormalities. The National Birth Defects Prevention Study (NBDPS) is one of the largest research efforts to ever address the issue.
The impact of many different drugs, including NSAIDs, on pregnancy outcomes, is a focus of the study.
"There are many medical conditions that require medication during pregnancy," Honein says. "One of the goals of our research is to try and provide better information to women so that they know the risks, if any."
Until more is known, Honein says, the best advice for pregnant women is to limit medication use to drugs that are absolutely needed.
"Women should not take medications that they don't need during pregnancy, and they shouldn't take a medication without discussing it with their doctor," she says.