Since 1982, a division of Hoffmann-La Roche, Inc. has
manufactured Accutane in the United States. It is used to
treat serious forms of cystic acne. Hoffmann-La Roche Inc.
is the prescription drug unit of the Roche Group, one of
the worlds leading research-oriented healthcare groups with
core businesses in pharmaceuticals and diagnostics.
Accutane is a highly effective oral medication used to
treat severe recalcitrant nodular acne that has not been
helped by other treatments, including antibiotics. Nodules
are inflammatory lesions with a diameter of 5 mm or
greater. The nodules may become suppurative or hemorrhagic.
"Severe" by definition means "many" as opposed to "few or
several" nodules.
Accutane, and its generics, contain Isotretinoin. People
who suffer from the embarrassments associated with acne
need to be aware that Accutane carries a significant risk
of adverse side effects in certain patients.
Health complications and the legal issues surrounding those
caused by Accutane involve the use by pregnant women and
associated birth defects and the use by teenagers and
associated depression and suicidal behavior. According to
the Food and Drug Administration (FDA), women who are
pregnant or who might become pregnant and women who are
breastfeeding SHOULD NOT take the drug.
Over the past two decades, Accutane has been linked to a
large number of dangerous, even life threatening, side
effects including:
* Birth Injuries and Birth Defects
* Depression and Suicidal Tendencies
* Psychiatric Diseases
* Central Nervous System Ailments
* Liver Disease
* Inflammatory Bowel Disease
* Hearing and Vision Problems
* Bone and Muscle Damage
* Pancreatic Damage
As with most prescription drugs, the side effects and
severity of complications associated with Accutane vary
from patient to patient and from case to case. Not every
fetus exposed to Accutane has resulted in a deformed child,
however, there is an extremely high risk that a deformed
infant may result if pregnancy occurs and the woman has/had
been taking Accutane even for very short periods. In
addition, there is an increased risk of spontaneous
abortion, and there have been reports of premature births
associated with the use of Accutane. There have also been
reported cases of IQs lower than 85 in some infants.
Similarly, not every teenager or young adult who takes
Accutane will experience depression or suicidal thoughts.
However, the potential for these side effects has caused
enough concern, and are serious enough, that the risks must
be addressed and taken very seriously.
Steps have been taken to help prevent Accutane's
potentially dangerous and undesirable side effects. Since
the introduction of Accutane, education has played a large
part in reducing and preventing the drugs' fetal risks by
reinforcing the importance of pregnancy prevention by women
using the drug.
Prevention has not stopped at educating patients. Frequent
updates and information on potential side effects of the
drug are provided to doctors and other health care
professionals. This includes notification to doctors that
Accutane may cause depression and/or psychosis, as well as
suicide, in some cases. This is to help ensure that health
care providers make educated and ethical decisions based on
the patients' history and personal needs. Doctors have also
been advised to monitor patients very closely for symptoms
of depression.
All prescription drugs come with educational material
included in the packaging. Accutane's packaging advises
patients to watch for signs of depression, such as feelings
of sadness, irritability, fatigue, loss of appetite,
trouble concentrating, thoughts of hurting oneself or
suicidal thoughts. Unfortunately, many patients who take
Accutane due not consider the possible side effects, as
their desire for clear skin and their need to regain a
positive self-image takes precedence.
Due to the number of potential complications associated
with Accutane and the severity of the side effects, the FDA
now requires any potential user to sign a consent form.
Additionally, pharmacists must give users a detailed
warning brochure from the FDA called a Medguide (Medication
Guide). Only three drugs in United States history have been
required the use of a Medguide: Accutane, Thalidomide and
Mifeprex.
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For more information on Accutane and other various
prescription drugs, visit LegalView's practice areas at
http://www.LegalView.com/ . Here, individuals can find the
latest on FDA drug warnings as well as controversial drugs
like the Chantix side effects or a Avandia warnings. Also
learn more about the recent potential for Vytorin and Zetia
litigation, visit http://zetia.legalview.com/ .
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