Accutane was prescribed for the treatment of severe acne that has not resolved with 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 anti-acne 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 of these 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, notified doctors that the drug “may cause depression, psychosis, and, rarely, suicidal ideation, suicide attempts and suicide."
Accutane's package warning first addressed the potential relationship between Accutane and depression in 1986. Although French officials required that the manufacturer add the risk of suicide to the package of the European version of Accutane in March 1997, the FDA did not require such a change in the USA until 1999.
However, the knowledge of the potential danger associated with Accutane did not become widely known until a Congressman’s son committed suicide. Representative Bart Stupak stated that his 17-year-old son’s suicide might be linked to the popular acne medicine.
In assessing how many potential suicide cases linked to Accutane, Representative Stupak stated, “(W)e 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.”
In September 2000, Accutane's manufacturer 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. Annual sales are approximately 1.2 billion dollars annually. Accutane's manufacturer placed profits before people and has done everything possible to prevent the public from learning of the psychiatric injuries and deaths associated with Accutane.
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.
At Wilentz, Goldman & Spitzer, we are committed to fighting for the victims affected by this drug. We continue to investigate claims by individuals harmed by Accutane. If you have taken Accutane and have experienced any of the side effects set forth above, please do not hesitate to contact us and ask to speak with an accutane lawyer.
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