Controversial Acne Drug Could Get Popped (With More Regulation)
Dec. 4, 2000 (Washington) -- Recent reports suggesting the
popular acne drug Accutane (isotretinoin) may trigger depression and suicide
have spurred a congressional hearing Tuesday to investigate whether tighter
controls need to be placed over the drug. But experts are cautioning that,
despite the drug's side effects, further restrictions on its use and
distribution could, in effect, lead to the drug's withdrawal.
Accutane was approved in 1982 as a treatment for severe acne.
It is the only drug proven to effectively control severe cystic acne, the most
serious form of this skin disease.
The congressional hearing follows a claim by Rep. Bart Stupak
(D-Mich.) that Accutane was responsible for his son's recent suicide. At a
press conference, Stupak called upon the drug's maker, Roche, to conduct
independent studies of Accutane's mood-altering effects. He also called for
enhanced surveillance over the drug.
According to the FDA, Accutane has been associated with about
44 suicides since 1983. But the agency says there is not enough data to
establish a definite link, although the drug does appear to have mood-altering
Calling the suicides "spontaneous," Roche says they
simply reflect "the multiple risk factors in the adolescents and young
adults afflicted with the disfiguring disease." The company also notes that
the drug's label already warns that Accutane has been associated with
depression and suicide, although a clear link has yet to be established.
Still, some experts fear that Tuesday's hearing might lead to
further restrictions because of Accutane's other well-known side effect: The
drug is known to cause birth defects.
Birth defects occur in an estimated one of every four babies
born to women who take Accutane while pregnant. But the number may be higher,
some experts believe, since about 40% of the pregnancies that occur among women
on Accutane end in a miscarriage.
As a result, the FDA has required the company to make a number
of labeling changes since the drug's approval, to the point where few drugs are
as explicitly labeled. But despite all the labeling changes, new patient
information inserts, and "Dear Doctor" letters alerting doctors to
these changes that the agency has required over the years, the absolute number
of pregnancies among women on Accutane has remained largely unchanged.
At an FDA meeting in September, a panel of medical experts
indicated that while the reported psychiatric events do not appear to be of
major concern, the ongoing pregnancies are of particular concern considering
that the use of Accutane has tripled since its approval. The panel commended
Roche for its ongoing efforts to educate physicians and patients, but then
recommended that a mandatory registration program be created to ensure that
patients use the drug as directed. Roche wants a voluntary registration