Congress Urges New Warnings on Teen Acne Drug
WebMD News Archive
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
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.