DANGEROUS
DRUGS
When an Improperly designed, manufactured,
or labeled drug or medical device causes serious
injuries or death the manufacture and others associated
with the making or distributing can be held liable.
At Goldstein Buckley, Cechman, Rice & Purtz
we provide experienced attorneys to seek monetary
damages. Drugs of all types can be dangerous, whether
prescription or over-the-counter. If you have been
injured, Click here to “Contact
Our Attorneys”
Accutane
Accutane, which was developed
by Hoffmann-LaRoche to
treat severe nodular acne has been linked with
serious side effects, including :
Depression, Mental Problems and Suicide.
Depression is characterized by symptoms of intense,
persistent sadness, anxiety, loss of pleasure from
usual activities, and loss of energy (National
Institute of Mental Health).
Accutane can also cause Pseudotumor
Cerebri, a condition of increased pressure
on the
brain. Symptoms include papilledema, headache,
nausea and vomiting, and visual disturbances.
Suicide accounts for more than
30,000 American deaths each year, and is the
third leading cause of death for people aged
15-24. (Penn State University and National
Institute of Mental Health). Often, teenagers
and young adults in this range are willing
to do almost anything to relieve themselves
of cases of extreme acne, increasing their
willingness to use Accutane despite warnings.
People taking Accutane exibit
a higher than normal rate of suicide attempts,
suicide, and aggressive and/or violent behavior
towards others. Even after discontinuation
of Accutane, these symptoms may continue and
further evaluation may be necessary.
Suicidal ideation is very hard
to diagnose because it is often deliberately
hidden by the patient. Despite this, many patients
experiencing suicidal thoughts send warning
signals and all mentions of killing oneself
should be treated very seriously. Birth Defects
Accutane can cause birth defects if taken
during pregnancy. You should never use
Accutane if you are pregnant or intending
to become pregnant while on Accutane or
up to a month after being on Accutane.
Accutane may also cause miscarriage, premature
brith, or death of the baby.
Female patients are required to have two
negative pregnancy tests in order to receive
their first prescription of Accutane. During
each month of treatment female patients are
required to have a negative pregnancy test
and may not receive further treatment until
proof of this.
Organ Faliure
Accutane has been linked to damages of the
colon, liver, kidney, eyes, and skin.
Accutane may also cause loss of bone
density and problems hearing.
Sadness, nervousness, anger, irritability, loss
of pleasure or interest in social activities, weight
and or appetite changes, sleep related problems,
drop in mental performance. These symptoms have
been known to cause suicide in patients.
Approximately 66 cases of suicide
and over 1300 cases of psychiatric problems by
Accutane users
have been reported to the FDA as of December 2000
reports USA Today. In 1986, Accutane's warning
label stated some potential risk of depression
linked to the drug but the US did not require US
bottles to carry a suicide risk warning until 1999,
as opposed to the French who required this as early
as 1997.
In 2001, the FDA announced that
new warning labels and consent forms would be
required for Accutane
users. The form urges patients to watch for signs.
Who is responsible?
The makers and distributors of Accutane, Hoffmann-LaRoche.
To a certain degree Hoffmann-LaRoche knew some
of the risks of depression caused by Accutane
before the drug was released. Other information
became apparent after the drug was released.
As uncovered by the Congressional
Investigation on Accutane, Hoffmann-LaRoche attempted
to supress information about serious psychiatric
risks of taking Accutane.
Additionally, record indicates
that in 1997, an FDA memo detailing a teleconference
call with representatives from Hoffmann-LaRoche
agreed that there appeared to be a problem associated
with Accutane and depression/suicide. In regards to birth defects, Hoffmann-LaRoche
and the FDA knew that retinoid medications have
been associated with birth defects, miscarriages,
and death of the baby.
Lawsuits
There have been lawsuits filed against Hoffmann-LaRoche
in regards to Accutane in multiple states.
In Florida, the family of Charles Bishop,
a 15-year-old who crashed a small airplane
into a building, has filed suit.
If you or a member of your
family has been injured by the use of Accutane,
you may have grounds to file a lawsuit against
Hoffmann-LaRoche. Injuries from Accutane
include, but are not limited, depression,
suicide, birth defects, or psychiatric problems
as outlined above.
Especially due to the nature
of some permanent side effects associated
with Accutane, Hoffmann-LaRoche needs to
be held responsible. Please contact one of
our experienced
attorney's to seek monetary
damages.
Additional Resources
·Federal
Drug Administration Regarding Accutane Side
Effects
·Statement
of Representative Bart Stupak, 10/05/2000
·Changes
to the Risk Management Program to Prevent Birth
Defects
·"The
Power of Accutane (FDA)"
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