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  PRODUCT LIABILITY
  Dangerous Drugs
     Accutane
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GOLDSTEIN, BUCKLEY,
CECHMAN, RICE & PURTZ, P.A.

Your Southwest Florida Personal Injury Attorneys
 

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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