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Brian Vastag

JAMA. 2002;287:832.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

In an effort to prevent drug-related birth defects, the US Food and Drug Administration has made it more difficult for physicians to prescribe Accutane (isotretinoin). In a January 9 letter to consumers and health care providers, Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, wrote that "a significant proportion of fetal exposures have occurred because patients were already pregnant" when they began Accutane therapy. In bold print, she added, "These events are entirely preventable."

Among the rule changes:

• All female patients must have two negative urine or blood pregnancy tests before receiving a prescription. For each month of therapy, female patients must return to their physician and provide another negative pregnancy test. The old rules required a single negative test.
  
• Patients who are or "might become" sexually active with a male partner are required to use two forms of birth control for at . . . [Full Text of this Article]