The drug, which is take by approximately 500,000
Americans each year, is essentially the only treatment for severe or
nodular acne, which patients colloquially call “pizza face.” The
condition affects mainly young men but also women in the 20s, 30s
and 40s. Sufferers often experience scarring.
Because the Food and Drug Administration began receiving an
increasing number of anecdotal reports of psychiatric problems
associated with Accutane’s usage, the agency has pressured the
drug’s manufacturer, Roche Pharmaceuticals, of Nutley, N.J to change
how it is prescribed.
New Patient Warnings
On Thursday, Roche sent dermatologists, family physicians,
psychiatrists and pharmacists material informing them that patients
who agree to take Accutane must get a medication guide and sign what
is called an “informed consent.”
Both address mental disorder side effects, saying “Some patients
while taking Accutane or soon after stopping Accutane have become
depressed or developed other serious mental problems.”
Despite the new warnings, Roche maintains there is no scientific
evidence of a link between Accutane and depression or suicide. A
Roche spokesperson says there is a “high incidence of depression and
suicide among boys who may not go to a doctor.” These new consent
forms are making “parents and physicians pay more attention to such
FDA, Roche and the National Institutes of Health are in
discussions to develop an appropriate scientific study to determine
if there is a “relationship between use of Accutane and any
psychiatric issues,” according to the Roche spokesperson.
Until then, the FDA will see if it receives fewer reports of
suicides or side effects now that this warning and consent program
is in effect, says FDA spokeswoman Jonca Bull.
Anecdotal Reports of Suicide on
The FDA is currently reviewing approximately 65 reports of
suicides, and some 1,370 cases of psychiatric problems, among
Accutane users since the drug first became available in 1982.
Bull says the number of reports it receives for adverse reactions
from any drug are usually about 1 percent to 10 percent of the true
total, since reporting of adverse events is voluntary. “As there is
greater marketing of a drug, there is increased knowledge of its
risk profile,” Bull says. The agency continues to change how
manufacturers label drugs, she says.
On the informed consent document, patients must acknowledge they
are aware of the potential mental health side effects and agree to
tell their physician if they start experiencing them. They also must
tell their doctor if they or any member of their family has had
The medication guide tells patients about Accutane’s use and its
potential side effects, including birth defects and mental
Doctors say the new policy is a responsible way to address the
growing concerns. Barbara Reed, a dermatologist in Denver, Colo.,
says she is aware of the anecdotal reports but in her practice has
not seen significant evidence of the depression.
“I will tell my patients that in my practice with hundreds of
patients I have known very few to be depressed, but they need to
tell me if they feel very sad while taking this medication,”
explains Reed. She said she would stop prescribing the drug if a
patient started getting depressed.
Other Accutane Restrictions
This is not the first restriction associated with Accutane’s use.
Accutane’s package insert noted links to depression since 1986 and
to suicide since May. Women who took it had to agree not to get
pregnant while on it because the drug can cause birth defects.
Because women still have been getting pregnant while on the drug,
Roche is now also requiring that woman take two pregnancy tests
before beginning treatment.
The House Reform Committee held hearings last month at which
patients described suicide attempts and depression that they
believed were due to Accutane. In October, Rep. Bart Stupak,
(D-Mich.) whose 17-year-old son killed himself while taking
Accutane, called for more studies to determine whether the drug can
cause suicidal thoughts. An FDA advisory committee also met in
September to address the mental health and pregnancy issues.
“Although it is difficult to make a reasonable linkage [between
suicide and the drug], the agency is compelled to do something
because the outcome…is so serious,” FDA’s Bull says. “It seemed
prudent to inform patients and prescribers if one suicide could be
prevented, if someone became aware of the risk.”