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Previous Volume 338:1128-1137 April 16, 1998 Number 16 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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Before marketing a new drug, the manufacturer almost never tests the product in pregnant women to determine its effects on the fetus. Consequently, most drugs are not labeled for use during pregnancy. Typically, descriptions of drugs that appear in the Physicians' Desk Reference and similar sources contain statements such as, "Use in pregnancy is not recommended unless the potential benefits justify the potential risks to the fetus." Since the risk has been adequately established for only a few drugs, physicians caring for pregnant women have very little information to help them decide whether the potential benefits to the mother outweigh . . . [Full Text of this Article]

Human Teratogenesis

A Historical Perspective

Thalidomide

Bendectin

Isotretinoin

Current Trends in Preventing Fetal Exposure to Teratogens

The Process of Establishing Risk or Safety of Drugs in Pregnancy

The Value of Studies in Animals

Epidemiologic Studies

Common Methodologic Issues

            Sample Size

            Effect of Maternal Diseases

            Recall Bias in Retrospective Studies

            Nonrandomized Observational Studies

            Voluntary Reporting

            Meta-Analyses

Counseling Women about Teratogenic Risks

The FDA Classification of Teratogenicity

Drugs of Choice in Pregnancy

Conclusions

Source Information

From the Motherisk Program, Division of Clinical Pharmacology and Toxicology (G.K., A.P., S.I.), the Departments of Pediatrics and Population Health Sciences (G.K., S.I.), and the Research Institute (G.K., S.I.), Hospital for Sick Children; and the Departments of Pediatrics (G.K., S.I.), Pharmacology (G.K., S.I.), and Medicine (G.K.), University of Toronto — both in Toronto.

Address reprint requests to Dr. Koren at the Division of Clinical Pharmacology, Hospital for Sick Children, 555 University Ave., Toronto, ON M5G 1X8, Canada.

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