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Possible Painkiller Link to Birth Defects

Study Shows NSAIDs May Up Risk of Heart Birth Defects During Early Pregnancy
By
WebMD Health News
Reviewed by Louise Chang, MD

Aug. 28, 2006 -- Babies born to women who take the most widely used pain relievers early in pregnancymay be at increased risk for specific heart-related birth defects, according to research from Quebec, Canada.

The study is one of the first to link use of nonsteroidal anti-inflammatory drugs (NSAIDs) -- such as prescription Motrin, Naprosyn, Voltaren -- during the first trimester of pregnancy to birth defects. But the findings must be confirmed, researchers say, and birth defects experts who were not involved with the study agree.

"If these findings turn out to be true, this is important information because so many women take these drugs early in pregnancy," March of Dimes medical director Nancy Green, MD, tells WebMD.

"About half of all pregnancies in the U.S. are unplanned. Many women don't know they are pregnant until well into their first trimester."

The Study

The Canadian study compared 93 births diagnosed with birth defects in 1,056 women who had prescriptions for NSAIDs filled during the first three months of a pregnancy to 2,478 births with birth defects in 35,331 women who did not fill prescriptions for the pain relievers. They looked at records from 1997-2003.

After adjusting for other known risk factors for birth defects, the researchers reported that women who took NSAIDs early in pregnancy were roughly twice as likely to have a baby diagnosed with any birth defect in the first year as women who did not have NSAID prescriptions filled, and they were three times as likely to give birth to babies with a structural defect such as an abnormal opening, or hole, in the dividing wall separating the right and left sides of the heart.

The most commonly prescribed NSAIDs were naproxen, sold by prescription as Naprosyn and over the counter in the U.S. as Aleve; ibuprofen, sold as prescription Motrin or generic ibuprofen and over the counter as Advil and Motrin; and the prescription Cox-2 inhibitor pain relievers Vioxx and Celebrex.

Vioxx and Bextra (another Cox-2 inhibitor) have been withdrawn from the market in the United States due to concerns that their long-term use is associated with an increased risk increase of heart attackand stroke.

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).

Other Concerns

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.

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