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Accutane Side Effects
Accutane and Depression
Though the drug's label previously listed depression as a
possible reaction, FDA strengthened the label warning in 1998
after reviewing cases with serious outcomes reported in the
years after the drug was approved. The new labeling states
that Accutane may cause depression and psychosis, and that
in rare cases it may cause suicidal ideation (thoughts of
suicide), suicide attempts, and suicide.
The label also advises providers that simply discontinuing
the drug may not remedy any psychiatric problems and that
further evaluation may be necessary. "In some cases,
stopping Accutane alone may not be enough to relieve the mood
changes," says Jonathan Wilkin, MD, director of CDER's
division of dermatologic and dental drug products. "Psychiatric
treatment may also be needed."
The relationship between Accutane and depression remains
unproven, but some patients have reported that their depression
subsided when they stopped the medication and came back when
they resumed taking it. And some who have reported problems
with depression while taking Accutane had no previous psychiatric
history. FDA considers the number of reports of serious depression
associated with Accutane high compared to other drugs in its
database.
From 1982 to May 2000, FDA received reports of 37 U.S. Accutane
patients who committed suicide, 24 while on the drug and 13
after stopping the drug. In addition to suicides, FDA received
reports of 110 U.S. Accutane users hospitalized for depression,
suicidal ideation, and suicide attempt during the same time
period. As of May 2000, FDA had received reports of 284 Accutane
users with non-hospitalized depression.
Accutane and Pregnancy
According to the FDA Consumer Magazine (March-April 2001),
when FDA approved Accutane, the drug was known to be teratogenic--able
to cause birth defects. It was designated as Category X, meaning
that it must be avoided under all circumstances during pregnancy.
Nursing mothers also should not use Accutane.
Though not every fetus exposed to Accutane becomes deformed,
the risk of birth defects among pregnant women is extremely
high. These defects include hydrocephaly (enlargement of the
fluid-filled spaces of the brain) and microcephaly (small
head), heart defects, facial deformities such as cleft lip
and missing ears, and mental retardation.
Reports in the literature suggest that about 25 to 35 percent
of babies will suffer a malformation after exposure, and that
doesn't account for other defects, such as learning disabilities,
that aren't detectable at birth. Miscarriages and premature
births have also been reported.
Though FDA approved labeling in 1982 that warned Accutane
should not be used in pregnant women, reports of severe birth
defects associated with the drug began to arrive in June 1983.
Over the following years, a series of labeling changes and
letters to pharmacists and prescribers of the drug stressed
pregnancy warnings and sought to increase awareness about
reported malformations.
Then, after an FDA review of pregnancy exposures to Accutane,
Roche launched the Pregnancy Prevention Program (PPP) in late
1988 to further educate women using Accutane and their physicians
about the dangers. The goal was to ensure that prescriptions
would only be given to women with severe recalcitrant nodular
acne who could comply with contraceptive requirements.
Roche sent PPP kits to physicians and encouraged them to
review pregnancy prevention materials with patients before
starting the drug. Materials included a contraceptive booklet,
checklists to help assess whether patients could adhere to
the drug's requirements, and consent forms that patients sign
to acknowledge their understanding of the risk of birth defects.
Roche also set up a toll-free line, made contraceptive information
available in 13 languages, and offered to pay for contraceptive
counseling and pregnancy testing by a specialist.
To further reinforce pregnancy prevention, Roche began packaging
Accutane in blister packs that include red and black warnings,
along with a drawing of a malformed baby and the "Avoid
Pregnancy" symbol.
Even though Accutane's labeling recommended use of two reliable
forms of contraception, there have been reports of pregnancies
occurring in patients who used hormonal contraception, including
pills, injectables, and implantables, while taking Accutane.
Accutane's labeling was updated in the summer of 2000. One
change emphasized the need for two reliable forms of contraception
for at least one month before taking Accutane, during treatment,
and for one month after discontinuing Accutane, even when
one of the forms of contraception is hormonal.
* Information excerpted from FDA Consumer Magazine (March-April
2001)
Accutane Side Effects
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