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Previous Volume 349:2556-2559 December 25, 2003 Number 26 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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Patients, prescribers, and policymakers often assume that the most serious short-term adverse effects of a drug are identified in pre-marketing studies, so recognition of unexpected harm after widespread use raises concern about "failures of the system." For drug-induced birth defects, however, the situation is reversed: the unfortunate reality is that we learn about virtually all teratogenic effects only after a drug has already received marketing approval, and of course, only after it has been used by pregnant women. Indeed, some teratogenic effects may be identified only after the drug has been in use for many decades. In these situations, the . . . [Full Text of this Article]

What Do We Need to Know?

What Study Designs Can Provide This Information?

How Can a Teratogen Surveillance System Be Developed?

Source Information

From the Slone Epidemiology Center, Boston University, Boston.

Address reprint requests to Dr. Mitchell at the Slone Epidemiology Center, Boston University, 1010 Commonwealth Ave., Boston, MA 02215.

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