Possible Painkiller Link to Birth Defects
Study Shows NSAIDs May Up Risk of Heart Birth Defects During Early Pregnancy
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 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
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
Vioxx and Bextra (another Cox-2 inhibitor) have been withdrawn from the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
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.