Accutane Changes Labeling
Thu Feb 28,11:54 PM ET
By Nicolle Charbonneau
THURSDAY, Feb. 28 (HealthScoutNews)
The maker of Accutane, the acne medication linked to numerous reports of
depression and suicide, has revised the controversial drug's labeling.
Hoffman-La Roche Inc. and the U.S. Food and Drug Administration (news -
web sites) (FDA) have agreed on several changes to the drug's package
insert, the most notable being a brochure for prescribers dealing with the
potential psychiatric side effects of Accutane.
However, experts on drug safety and suicide say no medical studies have
drawn a direct link between Accutane and depression or suicidal thoughts.
"There are case reports," says Alan L. Berman, executive
director of the American Association of Suicidology. "What is being
done is cautionary, but it is not based on any true research that
demonstrates that Accutane indeed is causative of suicide."
In a supplemental new drug application dated Jan. 30, Hoffman-La Roche
proposed changes in the "Warnings" section of the drug's product
insert that took effect this month.
Under "Psychiatric Disorders," the section lists the
possibility of depression, psychosis, suicidal thoughts, suicidal attempts
or even suicide, but it notes the link is not clear and stopping use of the
drug may not be enough to avoid the problem. The section will now refer
those who prescribe the drug to a brochure called Recognizing
Psychiatric Disorders in Adolescents and Young Adults: A Guide for
Prescribers of Accutane (isotretinoin).
The brochure's stated goal is to help prescribers determine whether a
patient taking Accutane may require a referral to a psychiatrist, noting
that "in extreme cases, it can mean the difference between life and
" The brochure lists behavioral warning signs for depression and
suicide in children and adolescents, and cautions that a link between
Accutane and depression should be considered even if other stresses exist
in a patient's life.
Depression is a major risk factor for suicidal behavior, and the
brochure warns that patients or the parents of a minor should be aware of
the signs of depression. If they appear, it says, patients or parents
should be told to stop Accutane treatment and seek immediate medical help.
The Boston Collaborative Drug Surveillance Program, co-directed by
epidemiologist Susan S. Jick, published an October 2000 study that found no
link between Accutane and an increased risk of depression, suicide or other
Jick, an associate professor of epidemiology and biostatistics at Boston
University, is familiar with the latest labeling changes. "The FDA …
has clearly been influenced by the anecdotal reporting of people who have
taken Accutane who have had various suicidal and depressive events,"
she says. Jick notes depression and suicidal behaviors are not uncommon
among adolescents, and she points out teens who receive Accutane are taking
the drug because they have severe acne. Their skin condition, she says, may
put them at greater risk for depression and suicidal thoughts, but there is
no clear evidence of this link. She adds the current medical literature has
not determined whether the depression or suicide rates among teens taking
Accutane is higher than those not using the drug.
Government records seem to tell a different story. FDA data show that
110 Accutane users have attempted suicide and 37 have killed themselves
while on the medication. On the market since 1982, the drug's link to
severe birth defects has already led to government restrictions on its
Depression has been listed as a possible side effect of taking Accutane
since 1986. In addition, the drug's labeling was updated in 1998 to note
that some people taking the medication had contemplated or even committed
Patients under 18 must now have a parent or legal guardian's written
consent to take the drug. A congressional investigation has looked into
Accutane's effects on mental health, and further congressional hearings are
set for this spring.
On Feb. 20, just before the American Academy of Dermatologists' annual
convention in New Orleans, Hoffman-La Roche scientists presented the
results of several Accutane studies at a closed-door consensus conference
attended by senior members of the academy. Following the presentations, the
academy members discussed a forthcoming policy statement on Accutane, but
they declined to say what the statement might cover, or when it might be
released. Hoffman-La Roche spokeswoman Gail R. Safian says, "We welcome
the discussion, and we're confident that the findings will be consistent
with previous observations that there's no cause-and-effect relationship
between Accutane and psychiatric events."
Hoffman-La Roche is currently printing the redesigned labels and new
brochures, which Safian says will be mailed in the next four to six weeks
to all U.S. dermatologists and any physician who has prescribed Accutane in
the past two years. Used as a drug of last resort to treat severe, scarring
acne, Accutane works by drying up the oil glands responsible for acne.
However, it's also known to affect the metabolism and the body's
gastrointestinal and neurological systems. More than 30,000 Americans
commit suicide every year, and the suicide rate among those aged 15 to 24 has
increased 200 percent in the last 50 years.
What To Do If someone you know shows signs of suicidal behavior, such as
depression, talking about suicide or dying, social withdrawal, drastic
behavior changes or previous suicide attempts, offer help.
Remember: Talking with someone about suicide doesn't cause him or her to
become suicidal. For more information on Accutane, check out the FDA's Accutane information page, or Hoffman-La
Roche's Accutane prescribing information. (You'll
need Adobe Acrobat Reader to read this page.)
You can also visit
Accutane Suicide Legal Help.