"There is evidence pointing to an association with depression," says an FDA spokeswoman, who spoke to WebMD on condition that her name not be used. "But there is not enough data to make a causal link between Accutane and psychiatric conditions."
In a session on Accutane last month, an FDA advisory committee recommended that the drug be distributed with "MedGuides" -- patient tools that the agency is developing to describe in plain terms the risks of certain medications. The agency also says it plans to require expanded use of consent forms with the drug; they're now used only for women.
Sidney Wolfe, MD, director of Public Citizen's Health Research Group, a nonprofit consumer-advocacy group, condemned Roche on Thursday, saying: "It is inexcusable that the company has gone for so long without restricting the use of Accutane," he says. Wolfe also puts blame on the government, calling the medication "one of the most dangerous drugs the FDA's ever introduced."
Doctors, though, say that the drug can be valuable. "This medication is wonderful, but it's not a drug to be taken lightly," Lisa Kauffman, MD, chief of dermatology at Georgetown University Medical Center in Washington, tells WebMD, "It is the only cure we have for certain kinds of acne." Accutane is the only medication available that actually shrinks the sebaceous glands that are involved in the condition.
Kauffman notes that the drug has a wide range of unpleasant side effects. She warns that only dermatologists should prescribe the drug -- not other doctors, who may not have a full understanding of its risks and benefits -- and says that patients on the medication should have monthly blood tests.