GMA:Precautions for Acne Drug

Dec. 6 -- Patients who take the powerful acne drugAccutane will soon get special warning brochures outlining sideeffects — including a possible, but not proven, link to suicide.

Acne patients must then sign off on a paper certifying that they understand the risks, health officials told Congress Tuesday.

The MedGuide warning brochures, attached to every bottle sold — along with tougher patient informed-consent form — may bedistributed as early as next month, said Dr. Jonca Bull, the Foodand Drug Administration’s deputy drug chief.

Her announcement came as lawmakers investigated whether Accutanecauses suicidal depression in teenagers, a charge made Tuesday bya teen who attempted suicide but survived. The charge wasrepeated by the parents of two teens who died.

Amanda Callais of Denham Springs, La., told ABCNEWS’ Good Morning America she attempted suicide when she was 14, two months after she started taking Accutane for her acne.

“It was actually kind of a spur-of-the-moment decision,” she said. “I took a shower and in the shower, I decided that I really didn’t want to go on. Within that 10- to 15-minute block, I decided that I would take my life and I walked out of the bathroom, and took three bottles of pills from the cabinet and overdosed and went back to sleep.”

The teen took 40 pills, but the drugs did not her. She woke up from her slumber with a terrible stomachache.

Back From the Edge

Accutane, a chemical cousin of vitamin A, is a prescription acne drug that cures what is called severe nodular acne, a type that causes large cysts and leaves permanent scars. The number of Americans taking the drug has doubled in the past decade.

Before taking Accutane, Amanda was an outgoing, happy, straight-A student, said her mother, Lori Callais. After the November 1997 suicide attempt, the girl was put on antidepressants but still couldn’t shake the depression. Meanwhile, the teen kept taking Accutane, after her psychiatrist and an emergency room doctor said the acne drug couldn’t be to blame for her mental state. That was when her mother learned from a friend who had seen a television report that the FDA had issued a warning linking Accutane with depression.