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 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. 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.