Congress Urges New Warnings on Teen Acne Drug

(Washington) -- A congressional committee on Tuesday urged the maker of a popular acne drug to do a better job of highlighting the medication's potential association with depression and suicide. Although the committee did not advocate any further restrictions on the use of Accutane, it did urge the drugmaker to conduct additional studies into the medication's mood-altering effects.

At a House of Representatives hearing, members of the Committee on Government reform asked Roche Pharmaceuticals to educate patients and families about the possible association between Accutane and depression and suicide. This education should take place on top of any previous actions taken to outline those concerns on the drug's label, the committee said.

Accutane was approved in 1982 as a treatment for severe acne when other treatments have failed. It is the only drug currently on the U.S. market that has been shown to effectively control severe cystic acne, the most serious form of this skin disease.

"Because of the drug's benefits, it is imperative that we understand all of the drug's risks," said Rep. Henry Waxman (D-Calif.), a member of the committee.

According to the FDA, Accutane has been associated with about 44 suicides since 1983. But whether the drug actually contributes to depression and suicide largely remains an unanswered question, despite its apparent mood-altering effects, the agency says.

"What we are seeing is mood changes," says Douglas Jacobs, MD, associate professor of psychiatry at Harvard Medical School. "The scientific evidence does not support a link between [Accutane] and depression, suicidal ideation [thinking about suicide], or suicide."

But considering that the drug is a derivative of vitamin A, there is cause for concern, says James O'Donnell, PharmD, MS, professor of pharmacology at Rush Medical College in Chicago. The link between vitamin A and depression is indisputable, he explains.

Roche says these "spontaneous" events simply reflect "the multiple risk factors in the adolescents and young adults afflicted with the disfiguring disease."

Still, for dermatologists, the committee meeting may have gone better than expected. Dermatologists had feared that lawmakers would also urge further restrictions on the drug's distribution, as was advocated recently by an expert medical panel, due to the drug's other side effects.

Accutane is known to cause birth defects, and as a result, a panel of medical experts recently suggested the adoption of a mandatory registry, which would limit the drug's distribution to only registered pharmacies and physicians. Roche and dermatologists want a voluntary system.

Medical experts and Roche oppose this mandatory registry because they say it would undermine the physician/patient relationship and make the drug unavailable to thousands of patients. Education, not regulation, is the key to the safe use of this drug, says the American Academy of Dermatology.

That doesn't mean a registry will not be established. Speaking before the committee, Jonca Bull, MD, deputy director of the FDA office responsible for Accutane indicated to the lawmakers that the agency is in negotiations with the drugmaker to establish a registry by mid-2001.

Also speaking at the hearing were family members of teens believed to have committed suicide or attempted suicide as a result of Accutane. Despite their experiences, however, these family members did not call for the drug's withdrawal.

"I am not angry with the drug company that makes [Accutane] because I believe that for many [teens], it is a godsend," said Michael Baumann, of Mundelein, Ill., who lost his son Daniel in December 1999. "But I think its distribution should be handled differently and additional research conducted by an independent source as to the potential hazards."

The hearing follows another well-publicized claim by Rep. Bart Stupak (D-Mich.) that Accutane was also responsible for his son's suicide. At a recent press conference, Stupak called upon Roche to conduct further studies into the drug's mood-altering effects and for the FDA to enhance its surveillance over the drug's distribution.

In a prepared statement submitted for the record, Roche said it now plans to fund an educational program for health care professionals regarding the drug's psychiatric concerns. "It is our expectation that this program will have broad benefits beyond the Accutane population by increasing the likelihood that Health care professionals will take advantage of an important opportunity to identify patients potentially at risk of psychiatric disease," reads the statement.