DRUG LIABILITY - ACCUTANE
ACCUTANE
Wilentz, Goldman & Spitzer is currently investigating claims
by individuals harmed by Accutane. Accutane is one of the top
three drugs for the most reported adverse side effects on the
FDA’s database. The FDA estimates that only one in one
hundred side effects ever get reported to the FDA. The injuries
we are currently investigating are suicidal depression, colon
injury, and liver and kidney damage.
Accutane is prescribed for the treatment of severe, disfiguring
cystic acne that has not resolved in response to milder medications
such as antibiotics. It works on the oil glands within the skin,
shrinking them and diminishing their output. Accutane is taken
by mouth everyday for several months and then stopped. The antiacne
effect produced by Accutane can last even after finishing a
course of medication. Accutane, generically known as Isotretinoin,
is a synthetic derivative of Vitamin A.
The side effects caused by this drug can be horrific.
Accutane gained notoriety in the mid to late eighties for the
severe birth defects caused by the drug. In addition to birth
defects, the drug is associated with causing severe psychiatric
side effects as well as many systemic side effects including
damage to the liver, kidneys, central nervous system, pancreas,
gastrointestinal tract, cardiovascular system, musculosketal
system, and the auto-immune system of the human body. Many side
effects are permanent, severe and devastating to an individual.
The fact that so many people are experiencing adverse effects
from this drug is not surprising.
In 1998, the Food
and Drug Administration advised doctors who prescribe
Accutane to monitor their patients for signs of depression.
Subsequently, the manufacturers of Accutane, Hoffman-LaRoche,
notified doctors that the drug “may cause depression,
psychosis, and, rarely, suicidal ideation, suicide attempts
and suicide.”
However, the knowledge of the potential danger associated with
Accutane did not become widely known until a Congressman’s
son committed suicide. Rep. Bart Stupak stated that his 17-year-old
son’s suicide earlier this year may be linked to the popular
acne medicine. Bart Stupak, Jr., also known as “BJ”,
shot himself in the head with his father’s gun in the early
hours of May 14. Stupak, who was a football player and a popular
student, killed himself after a prom-night party.
In assessing how many potential suicide cases linked to Accutane,
Rep. Stupak stated, “We are up over 100 reports, that’s
just what is coming in to us, so I believe there are probably
over a thousand cases.” Stupak also stated that, “the
average time is 88 days from when you start taking it, and the
effect is very sudden…. You are doing strange things at
3:00 a.m. and you are dead at 7:00 a.m.”
The FDA has received reports of 66 suicides and 1,373 cases
of psychiatric problems among Accutane users as of early December
2000, according to a report in USA Today. Accutane’s package
warning first addressed the potential relationship between Accutane
and depression in 1986. Although French officials required that
Hoff-LaRoche add the risk of suicide to the package insert of
the European version of Accutane in March 1997, the FDA did not
require such a change in the USA until 1999. As recently as November
2002, Roche Laboratories distributed a “Dear Doctor” letter
to physicians regarding severe adverse events---this time concerning
a greater risk of bone fractures during therapy with their medication.
In September 2000, Hoffmann-LaRoche reported to the FDA advisory
committee that since Accutane’s approval in September 1982,
five million people in the United State and twelve million people
worldwide have taken the drug. The majority of these people are
teens and young adults. Accutane, an oral medication, was approved
by the Food and Drug Administration for the treatment of recalcitrant
cystic nodular acne. However, through clever marketing to health
care providers and through generic advertising in media outlets
such as Nickelodeon, an estimated 90% of all Accutane prescriptions
are given for “off-label” uses. Accutane is one of
Hoffmann-La Roche’s top three drugs, having sales of approximately
1.2 billion dollars annually. We obtained testimony, given by
Roche’s representatives in the early 1980’s, indicative
that the manufacturer expected 100% of all patients taking the
drug to experience side effects. Unfortunately, Hoffmann-LaRoche
marginalized the more severe side effects of Accutane and focused
on minor conditions such as dry skin.
Hoffmann-LaRoche is part of “The Roche Group”, a
leading international health care company principally rooted
in the businesses of pharmaceuticals, diagnostics and vitamins.
The Roche Group is made up of numerous subsidiaries and is active
in more than 150 countries. They are the seventh largest pharmaceutical
company in the world. Our research on the manufacturer of Accutane
is extensive. The Roche Group is well known throughout the legal
system with regards to both civil and criminal activity. They
have been found guilty of fraudulent conduct, discovery abuses,
and patent infringement, including committing fraud against the
United States Trademark and Patent Office. In 1999, Roche budgeted
over one billion dollars for criminal fines, penalties, and settlement
of cases. Their corporate executives have been sentenced to prison
for their activities.
Because of Accutane, Hoffmann-LaRoche is currently the subject
of a Congressional investigation. The Subcommittee on Oversight
and Investigations of the House of Representatives Energy and
Commerce Committee reconvened its investigation into Hoffmann-LaRoche
and Accutane in early December of last year. One of the members
of that Committee, Congressman Bart Stupak, stated the following
during the Congressional Investigation:
The drug manufacture, Hoffmann-LaRoche, Roche here in the United
States, has continued to put profits before people. They have
done everything possible to prevent the American people from
learning of the psychiatric injuries and deaths associated with
Accutane. Even, today, I’m sure Roche will still deny any
casual effect of Accutane with the abortions, deaths, and suicides
caused by their product.
The President and Chief Executive Office of Hoffmann-LaRoche,
Inc. (USA), George B. Abercrombie, also testified before the
Committee. After giving various statements and making representations
under oath regarding studies, marketing, clinical trials, and
Roche’s relationship with entities in Mexico, Mr. Abercrombie
was told by two members of the Committee that his testimony was
not credible and was given in front of the Committee with a “straight
face”. Significantly, not a single member of the Committee
spoke in support of Hoffmann-LaRoche. This investigation is presently
ongoing.
The FDA has restricted the writing of prescriptions for Accutane.
They must be written on a valid prescription (telephone, fax,
and computer-generated prescriptions are not valid); they must
have a yellow sticker with a registration number on it; patient
education booklets must be dispensed with every filling; they
may not be written for more than a one-month supply; and they
must be filled within 7 seven days of being written. Even though
this drug is classified as a C-5 (no more harmful than other,
non-controlled, prescription drugs), the restrictions placed
upon its prescribing and dispensing are usually reserved for
more dangerous agents such as narcotics. In fact, the only other
drug with similar restrictions is Thalomid, a drug used to treat
many serious conditions, most commonly cancer.
With the evidence of adverse reactions that continues to mount
with its use, it is more apparent than ever that Accutane is
a drug with risks that may far outweigh its benefit. While the
true incidence of side effects remains unknown due to underreporting
and downplaying, the side effects we are aware of are enough
to warrant serious caution when dealing with Accutane.
» Contact David
Kane, Attorney at Law - phone: (732)
855-6402
Your Legal Rights
If you or someone you know has suffered serious side effects
(such as suicidal depression, colon injury, liver
and kidney damage, birth defects or injury) or
a
fatal injury that you believe may be related to your usage of
Accutane, you may be eligible to file a claim.
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