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Children's Health Author: U.S. Department of Health and Human Services Last Updated: Sep 7, 2017 - 10:06:33 PM

Opioid Pain Killers Linked to Increased Risk of Some Birth Defects

By U.S. Department of Health and Human Services
Mar 2, 2011 - 9:26:38 AM

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( - Babies born to women who take opioid pain killers such as codeine, oxycodone or hydrocodone just before or in early pregnancy are at increased but modest risk of birth defects, according to a study conducted by the Centers for Disease Control and Prevention.

The study, published in the American Journal of Obstetrics and Gynecology, found 2-3 percent of mothers interviewed were treated with prescription opioid pain killers, or analgesics, just before or during early pregnancy. The study did not examine illicit use of these medications.

The most commonly used opioid medications reported by women were codeine and hydrocodone. Treatment with opioid analgesics was linked to several types of congenital heart defects as well as spina bifida, hydrocephaly, congenital glaucoma and gastroschisis. The findings with some congenital heart defects are consistent with previous studies.

This study found that women who took prescription opioid medications just before or during early pregnancy had about two times the risk for having a baby with hypoplastic left heart syndrome (one of the most critical heart defects) as women who were not treated with these opioid medications.

Congenital heart defects are the most common type of birth defect, affecting nearly 40,000 births in the United States each year. Many infants with congenital heart defects die in the first year of life, and infants who survive often require numerous surgeries, lengthy hospitalizations and a lifetime of treatment for related disabilities.

While some medications are known to be harmful when taken during pregnancy, the safety of most medications taken by pregnant women has not been determined. The effects depend on many factors, such as:

-- How much medication was taken.
-- When during the pregnancy the medication was taken.
-- Other health conditions a woman might have.
-- Other medications a woman takes.

"Women who are pregnant, or thinking about becoming pregnant, should know there are risks associated with using prescription painkillers," said CDC Director Thomas R. Frieden, M.D., M.P.H. "They should only take medications that are essential, in consultation with their health care provider."

"It's important to acknowledge that although there is an increased risk for some types of major birth defects from an exposure to opioid analgesics, that absolute risk for any individual woman is relatively modest," said the study's lead author, Cheryl S. Broussard, Ph.D., CDC s National Center on Birth Defects and Developmental Disabilities. "However, with very serious and life threatening birth defects like hypoplastic left heart syndrome, the prevention of even a small number of cases is very important."

"Talk with your doctor if you are pregnant or planning a pregnancy and you have taken or are considering taking any medication. This includes prescription and over-the-counter medications, as well as dietary or herbal products," said Dr. Broussard.

The findings from the study, "Maternal Treatment with Opioid Analgesics and Risk for Birth Defects," were based on the CDC-sponsored National Birth Defects Prevention Study (, an ongoing population-based study that is the largest ever done on the causes of birth defects in the United States. Ten states have participated in the study: Arkansas, California, Georgia, Iowa, Massachusetts, New Jersey, New York, North Carolina, Texas and Utah.

The data from this study will help health care providers weigh the benefits of opioid medications along with their potential risks when discussing treatment options with patients who are or might become pregnant, including reproductive-age women who are not planning a pregnancy but might be at risk for unintended pregnancy.

For information about birth defects and opioid analgesic use, please visit:

For general information about medications and pregnancy, please visit or call 1-800-CDC-INFO.

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