Korean J Perinatol.  2010 Mar;21(1):48-58.

Pregnancy Outcomes after Peri-conceptional Medication Exposure; 10 Years Experience: Study for Application of Reproductive Toxicity Information

• Choi JS
• Han JY
• Ahn HK
• Lee SW
• Kim MH
• Chung JH
• Ryu HM
• Kim MY
• Yang JH
• Choi KH
• Han HW
• Kim SH
• Lee MB
• Han YJ
• Choi NM
• Cho YK
• Lee SY
• Hong DS
• Lim OR
• Hong SC

Abstract

PURPOSE
In Korea, pregnancy termination is frequently reported among women who took medications for an acute or chronic disease during pregnancy, for fear of teratogenic risk. We have previously shown that a service providing evidence-based information is helpful for women who week counseling to make a rational decision regarding their pregnancies. This study aimed to evaluate whether termination of pregnancy based on such perceptions, is justified using the 'DRug Exposure and risk Assessment in Moms' (DREAM) registry.
METHODS
The study included 5,032 consenting pregnant women from the clinic and call center at the Korean Motherisk Program, from November 1999 to October 2008. The DREAM registry recorded the pregnancy outcomes (preterm birth, low birth weight, intrauterine fetal death, and congenital anomaly) of 3,328 women.
RESULTS
Among women exposed to medications, time of exposure ranged from 3.5-4.6 weeks of gestation. There were 1,308 different drugs prescribed to these women. The drug most frequently prescribed was acetaminophen followed by chlorpheniramine maleate, and pseudoephedrine. There were 4.7% (n=156/3,328) women who underwent a voluntary abortion for fear of birth defects. We compared frequency of birth defects between exposed women and unexposed pregnant women in our institution during gestation. The frequency of major congenital malformations was 2.5% (n=74/2,977) in exposed group and 2.9% (n=75/2,573) in unexposed group (P=0.32). There was no statistically significant difference between exposed and control group in the rate of preterm births, intrauterine fetal death and low-birth weight babies.
CONCLUSION
We did not observe increased risk of congenital malformations and adverse pregnancy outcomes in a population of pregnant women exposed to a variety of medications. Therefore these medications are not considered teratogen.

Keyword

Pregnancy; Dvelopmental and reproductive toxicity; Teratogen; Drug exposure during pregnancy

MeSH Terms

Acetaminophen
Chlorpheniramine
Chronic Disease
Congenital Abnormalities
Counseling
Female
Fetal Death
Humans
Infant, Low Birth Weight
Infant, Newborn
Korea
Maleates
Parturition
Pregnancy
Pregnancy Outcome
Pregnant Women
Premature Birth
Pseudoephedrine
Risk Assessment
Acetaminophen
Chlorpheniramine
Maleates
Pseudoephedrine