Original researchTeratogenicity of recently introduced medications in human pregnancy
Section snippets
Materials and methods
We obtained from the FDA a list of 511 drugs that were approved for marketing in the United States between 1980 and 2000. We excluded radioactive agents and drugs that were subsequently withdrawn from the US market. For drugs that were structural variants of a single active entity (eg, insulin, lispro insulin, and insulin glargine), we only considered the one that was first approved. The remaining 469 drugs were selected for this study.
The risk of teratogenic effects associated with use of each
Results
According to information available in standard clinical teratology knowledgebases, the teratogenic risk in human pregnancy associated with therapeutic use of 91.2% of 468 drug treatments approved by the FDA between 1980 and 2000 was still undetermined at the time of this study (Table 1). The distribution of treatments among the three categories—1) teratogenic risk “none,” “minimal,” or “unlikely”; 2) teratogenic risk “small,” “moderate,” or “high”; or 3) “undetermined” teratogenic
Discussion
Teratology testing in rodents and rabbits is usually required before a new drug is approved for marketing. Such preclinical testing provides an important means of recognizing treatments that may have teratogenic potential in human pregnancy.14 However, preclinical studies are not always predictive of what will occur in humans, and both “false-positives” and “false-negatives” occur. It is, therefore, essential to perform studies of the outcome of pregnancies in women who have been treated by a
References (29)
Epidemiology of unintended pregnancy and contraceptive use
Am J Obstet Gynecol
(1994)Imagine having to read the Physicians’ Desk Reference
Reprod Toxicol
(1994)Animal studies and human risk
Reprod Toxicol
(1993)- et al.
Perception of teratogenic risk by pregnant women exposed to drugs and chemicals during the first trimester
Am J Obstet Gynecol
(1989) - et al.
The Pregnancy Registry program at Glaxo Wellcome Company
J Allergy Clin Immunol
(1999) - et al.
The sexual and reproductive behavior of American women, 1982–1988
Fam Plann Perspect
(1990) - et al.
Estimates of pregnancies and pregnancy rates for the United States, 1976–85
Am J Public Health
(1988) Unintended pregnancy in America and abroad
Fam Plann Perspect
(1988)Data availability in reproductive and developmental toxicology
Obstet Gynecol
(1994)- et al.
TERIS. Micromedex Reproductive Risk Information System (REPRORISK)
(2001)
Catalog of teratogenic agents. Micromedex Reproductive Risk Information System (REPRORISK)
REPROTOX. Micromedex Reproductive Risk Information System (REPRORISK)
Drugs in pregnancy and lactationA reference guide to fetal and neonatal risk
Chemically induced birth defects
Cited by (0)
- 1
Statement of potential conflict of interest: Dr. Friedman is senior author of the TERIS database.