The company had an exclusive patent on the drug for 20 years. However, generic brands of Accutane, such as Claravis, Amnesteem and Sotret, were released after the company's patent expired in 2002. Approximately 13 people have been prescribed Accutane.

Crohn's disease

Accutane, introduced in 1982, has been linked to hundreds of cases of Crohn's disease, a chronic, episodic, inflammatory bowel disease (IBD) that affects the entire wall of the bowel or intestines. In 2007, a jury ordered Roche to pay $2.6 million to a man who developed Crohn's disease after taking Accutane.

Depression

Accutane has also been linked to depression and suicide. The Food and Drug Administration (FDA) revised the label of the drug in 2005 to include the following warning:

In addition to the strengthened risk management program, FDA continues to assess reports of suicide or suicide attempts associated with the use of isotretinoin. All patients treated with isotretinoin should be observed closely for symptoms of depression or suicidal thoughts, such as sad mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating, or for mood disturbance, psychosis, or aggression. Patients should stop isotretinoin and they or their caregiver should contact their healthcare professional right away if the patient has any of the previously mentioned symptoms. Discontinuation of treatment may be insufficient and further evaluation may be necessary. (source: www.fda.gov/)

Birth defects?

Accutane has allegedly been linked to thousands of cases of birth defects and miscarriages. Roche has acknowledged that birth defects may be a result of Accutane use. According to information on Roche's website, www.rocheusa.com:

Accutane must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. . . . Birth defects which have been documented following Accutane exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system and [more].

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