People who take the acne medication Accutane will soon find warning brochures attached to the bottle outlining side effects — including a possible but not proven link to suicide. And they'll be required to sign a paper saying they understand those risks.
That was the message delivered to Congress on Tuesday by Dr. Jonca Bull, the Food and Drug Administration's deputy drug chief, who said the Medguide warning brochures and the tougher patient informed-consent forms may be distributed as early as next month.
Members of the House Government Reform Committee heard conflicting — and sometimes emotional — testimony about a possible link between the medication and suicide. Some parents reported that their children's depression left when they stopped taking the drug.
Accutane is a medication that's designed to treat serious acne — the kind that causes large cysts and leaves deep scars. But health officials are concerned that the medication is overprescribed and that most of the half-million Americans who take the drug each year have acne that's too mild to need it.
So, along with the brochures, the FDA plans to restrict who can take the medication and which doctors can prescribe it. What they're calling a "registry" is to counter a very well-documented Accutane problem: It can cause severe birth defects, and some 2,000 women have become pregnant while taking the drug since it was introduced in 1982.
Whether it causes depression or suicide is debated, but no one questions that Accutane leads to birth defects. Doctors counsel women who could become pregnant while taking the medication to use two forms of contraceptive.
In Utah, 12 women have reported "exposure" to Accutane while pregnant, according to Julia Robertson, education outreach coordinator for the state Health Department's Pregnancy Riskline. Normally, they receive three or four reports a year, she said.
The birth defects that result include severe malformations of the head, face, sinuses, ears and heart, as well as mental retardation. "It's a bad actor, but it's also a drug that helps a lot of people in need," Robertson said.
"The overwhelming risk of Accutane is pregnancy while taking it," said Dr. John Zone, a dermatologist at the University of Utah Hospital. "Children conceived on Accutane have very high risk of malformations. But when dermatologists prescribe it, we have a standard consent form provided by Hoffman-Roche that outlines risks very sharply and very clearly and the patient is asked to review and sign those. In the case of minors, the parent or guardian must review or sign it.
"Other than that, most of us believe it's fairly safe," he said. "It's a relative of vitamin A that has been on the market now almost 20 years. We have fairly large experience with it and I would say most dermatologists have serious doubt there's any effect on depression. A large study indicated there's no particular increased risk of depression and the literature would say there isn't."
Utah dermatologist Dr. Douglas Forsha says he has seen some depression in patients taking Accutane, "more likely in patients with a history of depression." But he describes the percentage as "small" and said he sees no link with suicide. The opposite, in fact, "is apparently the case" as patients respond positively to having their acne treated.
When he encounters depression, Forsha said, he manages it "with the help of the patients, their parents, even a psychologist if needed.
Depression has been listed as a possible side effect on Accutane's label since 1986 and two years ago the FDA strengthened the warning to say that suicide was also possible. But questions about suicide and Accutane gained national attention two months ago when Rep. Bart Stupak, D-Mich., said Accutane was responsible for his 17-year-old son's suicide.
The FDA cautions that there's no scientific evidence that Accutane causes either depression or suicide. But because it has received 66 reports of suicides among Accutane users or former users, it issued the label warning.
Many could have been depressed before taking Accutane or despite it, and the medication does not seem to cause the brain chemical changes needed to spark depression, Harvard University suicide expert Dr. Douglas Jacobs, a Roche consultant, told Congress. Of the about 1 million teenagers who suffer depression, 2,000 commit suicide each year whether they take the medication or not, he said.
That makes sense to Zone. "Severe acne in a teenager is a very depressing event. The kid is usually just mortified, at a time when the emotional state is somewhat fragile. Severe acne is debilitating to psychological development, so it becomes very difficult to separate the chicken and the egg."
The FDA said it is concerned about reports that the depression of a few patients eased when they quit Accutane but came back the next time they took the drug. Now the FDA, Roche and the National Institutes of Health will collaborate on a study to determine if the link is real or coincidental.
E-MAIL: lois@desnews.com