WASHINGTON - Patients who take the powerful acne drug Accutane will soon get special warning brochures outlining side effects - including a possible, but not proven, link to suicide. Patients must then sign a paper certifying they understand those risks, health officials told Congress Tuesday.
The MedGuide warning brochures, attached to every bottle sold - along with tougher patient informed-consent forms - may be distributed as early as next month, said Dr. Jonca Bull, the Food and Drug Administration's deputy drug chief.
Also, the FDA is developing tougher restrictions on who can take Accutane and which doctors can prescribe it, Bull told the House Government Reform Committee. This so-called registry is an attempt to counter another Accutane problem: 2,000 women have gotten pregnant while taking Accutane since the drug began selling in 1982. Accutane causes severe birth defects.
A registry could be in place ''as early as next summer,'' Bull said.
Her announcement came as lawmakers questioned whether Accutane causes suicidal depression in teen-agers - a charge made Tuesday by one teen who attempted suicide but survived. The charge was repeated by the parents of two teens who died.
''Within days of taking Accutane, my mood began to change. Within weeks, I was crying,'' recalled Amanda Callais of Denham Springs, La., who at age 14 attempted suicide, two months after beginning Accutane therapy.
Before taking Accutane, Amanda was an outgoing, happy, straight-A student, said her mother, Lori Callais. After her November 1997 suicide attempt, she was prescribed antidepressants that didn't help. Doctors insisted Accutane couldn't be to blame, so she kept taking it until February 1998, when her mother learned from a friend that the FDA had issued a warning about Accutane and depression.
''I threw the pills away and within days watched my daughter make a miraculous recovery,'' Mrs. Callais testified, blasting Roche and FDA for not requiring that doctors tell patients about the risk before prescribing the pill.
Accutane can cure very severe acne, the kind that causes large cysts and leaves deep scars - and it's only supposed to be used by such patients, not people with mild, everyday acne. Yet critics estimate that most of the 500,000 Americans who try it each year have acne too mild the drug.
Accutane's best-known risk remains birth defects so severe that doctors are supposed to ensure women use not one but two forms of birth control while taking it.
Depression has been listed as a possible side effect on Accutane's label since 1986, and the FDA in 1998 strengthened the warning to say suicide, too, was possible. The suicide link gained wide attention in October when a Michigan congressman, Democrat Bart Stupak, blamed his 17-year-old son's suicide on Accutane - and charged that patients and families aren't warned about the risk, which appears in the fine print of drug labels that many consumers never receive.
There is no scientific proof that Accutane causes depression or suicide, the FDA cautions. But the agency has received 66 reports of suicides among Accutane users or former users.
Many could have been depressed before taking Accutane or despite it, nor does Accutane seem to cause the brain chemical changes necessary to spark depression, Harvard University suicide expert Dr. Douglas Jacobs, a Roche consultant, told Congress. Also, of the estimated 1 million teen-agers who suffer depression, 2,000 commit suicide each year whether they take medication or not, he said.
Still, the FDA is concerned that the depression of a few patients eased when they quit Accutane, but came back the next time they took the drug. So it is working with Roche and the National Institutes of Health to study if the link is real or a coincidence.
On the Net:
FDA site: http://www.fda.gov
NIH site: http://www.nih.gov
Roche site: http://www.roche.com
House Government Reform Committee site: http://www.house.gov/reform