[William Grigg] said the requirements were prompted by 62 reported cases of birth defects caused by the drug since it was introduced in 1982, although the FDA believes that the actual number is much higher. The FDA says the risk of a pregnant Accutane user having a deformed child is one in four or greater.

The FDA embraced a proposal by Hoffman-La Roche to sell Accutane only in a package in which explicit patient warnings-including a sketch of a pregnant woman with a red X through it-would be sealed under clear plastic at the factory to make sure the patient would see them.