The Safety of Penicillin V: Oral Penamecillin Use During Pregnancy The Importance and Limitation of Recall Bias

Autor: Andrew E. Czeizel, Jørn Olsen, Henrik Toft Sørensen, Magda Rockenbauer
Rok vydání: 1999
Předmět:
Zdroj: Congenital Anomalies. 39:267-279
ISSN: 1741-4520
0914-3505
DOI: 10.1111/j.1741-4520.1999.tb00566.x
Popis: The purpose of the study was to check the human teratogenic potential of penicillin V: oral penamecillin treatment during pregnancy in the population-based dataset of the Hungarian Case-Control Surveillance of Congenital Abnormalities between 1980 and 1996. The pairs of cases with congenital abnormalities and their matched population controls without congenital abnormalities were evaluated, in addition the data of total population and of patient control groups as referents were compared with the data of congenital abnormality groups. In the three study groups there were 38,151 pregnant women who had newborn infants without any defects (population control group), 22,865 pregnant women who had newborns or fetuses with congenital abnormalities, and 812 mothers of informative offspring with Down syndrome (patient controls). In the population control group 2,246 (5.9%) pregnant mothers were treated with penamecillin, in the case group 1,597 (7.0%) pregnant women had penamecillin treatment while in the patient control group 63 (7.9%) mothers used penamecillin during pregnancy. The use of penamecillin treatments during pregnancy was higher in the total case (i.e., congenital abnormality) group, than in the total population control group. However, the highest use of oral penamecillin was found in the patient control group. The case-matched population control pair analysis did not show a higher use of medically documented penamecillin during the second-third months of pregnancy, i.e., in the critical period for most major congenital abnormalities. In addition, an association between medically documented penamecillin use during the second and third months of gestation and different congenital abnormality groups was not found when total population control group or patient control groups were used as referent. Thus, the reported higher use of penamecillin among the mothers of cases and patient controls can be explained mainly by recall bias. Thus, treatment with oral penamecillin during pregnancy did not indicate detectable teratogenic risk to the fetus.
Databáze: OpenAIRE
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