Experts: Safe overall, drug demands caution

Dr. Daniel Buffington was already assembling all the information on Accutane he could find when the first calls came in about 9 Wednesday morning.

Authorities had said Charles Bishop, the 15-year-old who crashed a small plane into the Bank of America building in Tampa last weekend, had been prescribed Accutane, a common acne drug that has been linked anecdotally to depression and suicide.

The police were looking into it, and Buffington knew patients, their parents and other doctors would be asking: How strong is that link? Is Accutane safe?

The short answer, he and other experts say, is yes. There is no scientific evidence to show that Accutane can lead to depression or suicide.

But the U.S. Food and Drug Administration does require doctors and the drug's manufacturer to tell patients the prospect has been raised, and more research is planned.

"If you look at the history of Accutane over the years, it's gotten the FDA and the health profession's attention because it has a potential side effect" -- suicide -- "that is not predictable," said Buffington, a clinical pharmacologist in Tampa who advises patients and doctors about drugs, including Accutane, and potential problems.

But the risk, if there is one, appears tiny, said Buffington, who has a 12-year-old son struggling with the early stages of acne. While his son isn't ready for Accutane, Buffington would consider it.

"I wouldn't feel uncomfortable," he said. "Would I be . . . aware of the potential complications? Yes. Would I caution him what to watch for? Yes. But paranoid to use it? No."

Dr. Neil A. Fenske, professor and chairman of dermatology and cutaneous surgery at the University of South Florida in Tampa for 25 years, said he has treated hundreds of patients with Accutane, with no reports of psychiatric problems.

He does not think the drug has psychotic effects, but he does counsel patients and their parents about the possibility. Patients and their parents are urged to watch for signs of depression, including lethargy, changes in sleep patterns and thoughts of hurting themselves or others.

"We tell them yes, there's some soft evidence out there," Fenske said. "If you get depressed, we stop it."

The FDA says it has received reports of 37 suicides and 110 attempted suicides by Accutane patients between 1982, when the drug was approved, and May 2000, plus some 300 more cases of depression. Of those who committed suicide, 84 percent were young males, with an average age of 17. The agency noted that's not out of line with national suicide statistics.

Accutane is very effective for severe nodular acne, which is marked by large cysts that can pus or bleed and which often scar.

It works by stemming the body's production of sebum, an oily substance that moisturizes the skin. In some teens, the glands that produce sebum run amok, creating reservoirs of sebum in the pores that become breeding grounds for bacteria. Acne follows.

Side effects may include dry skin, dry eyes and temporary hair thinning. The drug also causes severe birth defects, and it is not to be used by women who are pregnant or intend to get pregnant.

About 12-million people have been prescribed the drug.

Questions about Accutane's effect on mental health became public in 1998, when the FDA required the drug's manufacturer, Roche Laboratories, to add a warning saying it had received reports of "cases of depression, psychosis, and, rarely, suicide ideation, suicide attempts and suicide associated with the use of Accutane."

The relationship between Accutane and mental problems is what's known as temporal: People took the drug, and some became depressed, or committed suicide. What's missing, the FDA acknowledges, is proof of a causal relationship: Something that shows one led to the other.

"No one knows if Accutane caused these behaviors or if they would have happened even if the person did not take Accutane," the FDA said.

The notoriety intensified in 2000 when B.J. Stupak, 17, the apparently happy and well-adjusted son of U.S. Rep. Bart Stupak, D-Mich., shot himself. The congressman and his wife blamed Accutane, and Stupak called for an FDA investigation.

That October, Stupak also urged the FDA to require patients or their parents to fill out a consent form indicating they understand Accutane may be linked to suicide.

The FDA adopted Stupak's recommendation in January 2001, although an FDA panel found "the evidence does not support a causal association between Accutane and psychiatric illness," agency records show.

Local dermatologists said they think the drug has gotten more scrutiny than it deserves because of the death of a congressman's son. Stupak's office did not return phone calls Wednesday.

The most recent national study of Accutane, published in the November issue of the Journal of the American Academy of Dermatology, came to the same conclusion. The FDA said it is designing a large, national study it hopes will settle the issue.

"You would be amazed at how many many patients come in that really need Accutane but don't want to take it because of what they've heard," said Dr. Roger Golomb of Clearwater Dermatology, who said he prescribes Accutane sparingly. "Stupak almost got the drug off the market. That would have really hurt a lot of people."

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