Accutane Label to Carry Photo of Deformed Baby
In an unprecedented move, federal regulators have ordered the makers of the anti-acne medicine Accutane to warn customers of potential birth defects by using a picture of a deformed baby on the drug’s packaging.
“It is an attempt to emphasize to people that we’re not talking about a remote risk of some minor birth defect . . . but a very high risk of extremely severe birth defects that can, in effect, make the child unable to function,” Food and Drug Administration spokesman William Grigg said.
The FDA also will force female patients to sign a consent form stating that they understand the risks associated with the powerful drug, said Carolyn R. Glynn, a spokeswoman for the drug’s manufacturer, Hoffman-La Roche of Nutley, N.J.
Letter’s Contents Released
The FDA on Friday released contents of a letter to the firm about the warnings. The company had released the letter Thursday.
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.
Glynn said that the company basically agrees with the FDA’s order, which does not stray much from the advisory panel’s recommendations, but Hoffman-La Roche believes the photo “may be more appropriate . . . to use on the patient consent materials” signed in the doctor’s office.
FDA Embraces Proposal
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.
Since its introduction, Accutane has carried specific and explicit warnings about the high risk that it will cause birth defects if taken during pregnancy.
Those warnings were strengthened in recent years, but the FDA grew concerned that too many women, and perhaps doctors, were ignoring them.
