Since the drug's debut, the FDA has received nearly 400 complaints of serious depression and dozens of suicide reports.
Manufacturer Roche, of Nutley, New Jersey, declined to talk to CBS 2 on camera but maintains Accutane is safe when taken as directed. A spokesperson says there is no scientific proof the drug causes depression and points out that depression among teens, especially boys, is unusually high, regardless of Accutane use.
But a growing list of parents say they believe Accutane is a killer.
For 4 agonizing years, Ginny and Jim Palazzolo have lived with the unsettling belief that Accutane somehow drove their 19-year-old son, Chris, to kill himself.
"There's no doubt in my mind that is what caused it," Ginny maintains.
The Palazzolos are among the people suing Roche.
In 2000, Congressman Bart Stupak's popular 17-year-old son B.J. fatally shot himself in the head after 5 months on Accutane. Stupak says there were no warning signs.
"What we are dealing with here is a very dangerous and powerful drug," he says.
Amanda Callais says she believes the drug drove her to almost end her life.
"I just didn't care anymore and on November 14, 1997, I took 40 pills and went to sleep never expecting to wake up," she says.
Accutane is a derivative of vitamin A. There's evidence that very high doses of vitamin A can cause depression or psychosis but there's no proof Accutane has the same effect. Yet an investigation by Congressman Stupak has turned up as many 100 suicide cases he says are tied to Accutane.
Still, the $600 million a year drug has plenty of supporters.
"I think Accutane is probably one of the biggest advances we have in acne treatment over the past century," says Dr. Robyn Gmyrk, a dermatologist who considers Accutane a life changer for the 12 million people around the globe who take it, especially for patients with disfiguring cystic acne.
Because of the risks, Accutane is supposed to be a drug of last resort, but critics charge it is prescribed too often for mild acne. They blame the FDA and manufacturer Roche for not warning the public about mental health risks. The most prominent US warnings have focused on avoiding pregnancy because Accutane can cause birth defects.
In 1997 France changed its warnings about Accutane to include suicide attempts, but it wasn't until May 2000 that package labels given to US consumers were strengthened to include depression, suicidal thoughts, and suicide.
"I think the FDA has not done a good job and I think the manufacturers have done less of a good job in trying to be up front with the American people," Congressman Stupak says.
Under mounting pressure, the FDA months ago began requiring Accutane prescriptions be accompanied by a government-approved medication guide that lays out all the risks and a detailed consent form.
Yet that did not help Accutane user Matthew Turney. Two months ago, 16-year-old Matthew of upstate New York shot himself even though he had shown no signs of depression. Because of the spontaneous nature of Matthew's suicide and that of other Accutane users, his parents say the government warning system is grossly inadequate.
"You have, from the last time he was seen by friends, to the time he was killed, 10 minutes!" his father, Martin, says. "There's not a warning that you could place on that package that could have prevented what happened to him."
Back at the Pallazolo home, Chris's parents struggle to accept reality. She says she believes the only responsible thing the FDA can do is ban Accutane until scientists conduct more studies to determine exactly who is at risk.
"It's not right that they should have tis drug on the market the way it is now," his mother, Ginny, says.
Because of continuing reports of Accutane's adverse effects, several doctors say they fear the drug will be taken off the market.
The FDA would not grant us an on-camera interview but says there are no plans to pull Accutane. However, the agency confirms it is considering establishing a registry of doctors to better regulate who's prescribing Accutane and under what circumstances.
Dermatologists we spoke with are not happy about the registry. They say too much government oversight may make doctors hesitant to prescribe Accutane and that that ultimately jeopardizes patients who could suffer permanent scarring if they don't get Accutane.
If you or your children take this drug, you must weigh the risks carefully.
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