FRIDAY, Jan. 11, 2002 (HealthDayNews) -- The discovery of an Accutane prescription in the home of the teen-ager who crashed a small plane into a Florida office building last week has reopened the debate on whether the already controversial acne drug has dangerous psychiatric side effects.
Government records show that 147 people have attempted or committed suicide while taking the popular medication, but the drug's manufacturer and medical experts call reports of the link purely anecdotal. No clear cause-and-effect relationship has been proven to exist between Accutane and major depression or suicide, they add. The drug's link to severe birth defects, however, has already led to government-mandated restrictions on its prescription.
Investigators reported Jan. 8 that the Accutane prescription was discovered in the home of 15-year-old Charles Bishop, who died Jan. 5 when the single-engine Cessna aircraft he was flying barreled into the 42-story Bank of America building in Tampa.
The high school freshman had stolen the aircraft from a flight school at the St. Petersburg-Clearwater International Airport. In his pocket, police found a note of support for Osama bin Laden and the Sept. 11 terrorist attacks, according to news reports.
Police described him as a troubled loner. His family, friends and teachers, however, have said he was friendly, never obviously depressed, and had no medical history of psychological difficulties or drug abuse.
But the St. Petersburg Times reported yesterday that his parents, Julia Detore and Charles Bishara, had made a bizarre suicide pact of their own after their marriage license was denied when they tried to elope.
In 1984, the newspaper said, the couple tried unsuccessfully to fill their car with carbon monoxide. When that didn't work, the couple agreed that Detore would stab Bishara with a butcher knife, then slash her wrists. But after Detore stabbed Bishara, they called an ambulance, and Detore was charged with assault with a dangerous weapon with intent to commit murder.
The case was later dropped, and Detore and Bishara were married after she became pregnant with Charles in 1986, according to the Times. The marriage then fell apart, and Julia Bishara moved away with her son. She told police she changed their last name to Bishop during the Gulf War because Bishara was an Arabic name, according to the Times.
While police could confirm the Accutane prescription was found at the teen-ager's home, they could not say yet whether the teen-ager was taking it or what the dosage was, Tampa police spokeswoman Katie Hughes said in a statement. Toxicology tests that could reveal the presence of the drug in the youth's body will not be available for several weeks, the statement added.
Accutane, which is manufactured by Hoffman-La Roche Inc., is used as a drug of last resort to treat severe, scarring acne. It works by drying up the oil glands responsible for acne, but it's also known to affect the metabolism and the body's gastrointestinal and neurological systems.
The drug first hit the market in 1982. Between that year and May 2000, the U.S. Food and Drug Administration's (FDA) MedWatch recorded 110 cases of Accutane users who attempted suicide and 37 cases of people who killed themselves while taking Accutane or after stopping the drug.
Accutane's links to severe birth defects recently led to FDA-mandated changes in prescribing practices and labeling. The drug can now only be prescribed in one-month intervals, and patients under 18 must have a parent or legal guardian's written consent to take it.
Depression has been listed as a possible side effect of taking Accutane since 1986, and, in 1998, the drug's labeling was updated to note that some people taking Accutane had contemplated or even committed suicide while taking it.
Several experts note, however, that none of the studies on Accutane have found a clear link to depression or suicidal behaviors.
"The basic problem is that depression is very common," said Dr. Leslie Citrome, a clinical associate professor of psychiatry at New York University School of Medicine. "One in four American women and one in 10 American men can expect to get a clinical depression at one point in their lives."
"It would be very hard to detect any increase in risk with something like [Accutane]," Citrome added. "Also, the issue is that the very people who are taking [Accutane] may be more prone to depression because of their self-image."
Theoretically, they should feel better once their complexion improves, Citrome said, but they may feel worse if they don't feel that their life improves as well.
The FDA "does not directly sponsor studies but we have been working
with the National Institute of Mental Health to investigate the relationship
between retinoids and nervous system changes," says Dr. Jonathan Wilkin, the
director of the FDA's Dermatologic and Dental Drug Product Division in
Rockville, Md.
If such a link is established, he says, "the FDA would establish the link
for a small group of patients and the idea
would be to identify what their characteristics are and screen each
patient."
Dr. David Pariser, a spokesman for the American Academy of Dermatology (AAD), said many dermatologists who have prescribed Accutane in the two decades since it came on the market tell anecdotal stories about mood changes in some patients.
A congressional investigation has looked into Accutane's effects on mental health. Rep. Bart Stupak (D-Mich.) pushed for the inquiry after his 17-year-old son shot himself in May 2000 while taking Accutane. Before his suicide, Stupak's son had been active in sports and president-elect of his high school.
However, Gail Safian, a spokeswoman for Hoffman-La Roche, said research hasn't proven that Accutane causes depression or suicide. "Based on all currently available data, there is no cause-and-effect relationship between Accutane and psychiatric events," she said.
"What's more relevant is the multiple risk factors in the population of young people who have acne," Safian added. "There is a lot of literature that associates acne and depression. All of the studies that have been done show that there's no increased incidence of suicide or depression among Accutane users."
She also said Hoffman-La Roche is taking the events in Florida seriously and will consult with the prescribing physician and get Bishop's medical records to better understand the situation.
Further congressional hearings on Accutane are scheduled for the spring. And dermatology experts will hold a national consensus conference on the drug during next month's meeting of the AAD. At the meeting, experts are expected to produce a scientific statement after reviewing all the available information on Accutane and depression and suicide, as well as other issues related to the drug.
What To Do
Check out the product information on Accutane from Hoffman-La Roche. (You'll need Adobe Acrobat Reader to read this page). Or visit the FDA's Accutane information page.
The Accutane Suicide Help Line describes some of the complaints made about this drug.
For information on suicide, visit the National Institute of Mental Health.
