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NSAIDs early in pregnancy tied to malformations.

TUCSON, ARIZ. -- Mothers who take NSAIDs during the first trimester of pregnancy face a 2.2-fold increased risk of giving birth to infants with congenital malformations, results from a large, long-term population study show.

In addition, a subset analysis revealed a 3.3-fold increased risk for cardiac septal system defects among infants born to mothers who used NSAIDs during the first trimester, Dr. Anick Berard reported at the annual meeting of the Teratology Society.

The findings are important because increasing numbers of women are being exposed to NSAIDs in early pregnancy. "There is controversy over the risk between maternal exposure and congenital anomalies," said Dr. Berard of the research center at Sainte-Justine Hospital, Montreal. "Several studies have found a significantly increased risk of cardiac defects in the offspring of users of NSAIDs in pregnancy. Also, we have toxicological studies that have demonstrated cardiovascular developmental toxicity from NSAIDs with a high COX-1:COX-2 ratio."

She and her associates analyzed data from all pregnancies that occurred in the province of Quebec between Jan. 1, 1998, and June 30, 2003. The pregnancy registry consisted of three linked databases: the RAMQ, which provides information on medical diagnoses and procedures and drugs dispensed; the MedEcho, which provides hospitalization data; and the ISQ, which provides birth and death data, as well as demographic information about the mother, father, and infant.

To be included in the study, women had to be between 15 and 45 years of age on entry into the pregnancy registry, which was defined as the first day of gestational age based on the last menstrual period. Other inclusion criteria were having a live singleton birth, being covered by the RAMQ drug insurance plan at least 12 months before and during pregnancy, and being prescribed an NSAID or other medications during pregnancy. Women who used indomethacin, aspirin, diclofenac, or misoprostol were excluded from the study.

The researchers used ICD-9 codes 740-759 to identify offspring with congenital anomalies. They also stratified analyses by anomalies of major organ systems.

Up to 10 mothers of infants with no congenital anomalies were selected as controls for each case. The cases and controls were matched for maternal age, region of residence, diabetes status, and year of conception. Definition of exposure to an NSAID was a filled prescription for an NSAID in the first trimester.

Dr. Berard reported that 36,387 women met inclusion criteria for the study. Of those, 2,571 (7%) had offspring with at least one malformation.

Mothers who used NSAIDs during the first trimester of pregnancy were similar to nonusers in regard to maternal age at conception and place of residence. However, they were more likely to be on welfare or living alone, and they were also generally less educated.

Multivariate analysis revealed that mothers who used NSAIDs during the first trimester were 2.2 times more likely than controls to have a baby with any congenital anomaly.

The study will appear in a future edition of Birth Defects Research.


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Title Annotation:News; nonsteroidal anti-inflammatory agents
Author:Brunk, Doug
Publication:Internal Medicine News
Geographic Code:1USA
Date:Aug 1, 2006
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