Congress Urges New Warnings on Teen Acne Drug
Dec. 5, 2000 (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
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