The prescription medication Accutane – also known in generic forms as Isotretinoin, Sotret and Raccutane – has previously been prescribed to treat severe recalcitrant acne. Introduced in 1982 by Hoffman-LaRoche, Accutane has been used to treat over 13 million people afflicted with acne since its introduction.
While effective in treating the skin condition, Accutane is also known for causing a list of side effects which include, but are not limited to: depression, joint pain, birth defects and miscarriages, heart attacks, strokes, seizures, and inflammatory bowel disease. Because of this list of side effects, the FDA has previously required the medication to bear a black box warning on containers.
The side effects of Accutane have been known for some time now, but despite Hoffman-LaRoche terminating production of the drug in 2009, it continues to be manufactured and distributed by other pharmaceutical companies under various names. Health care providers continue to prescribe the drug despite its list of side effects and can be held accountable and responsible should they fail to inform adequately the risks involved with taking Isotretinoin.
Millions of patients have taken this drug to combat acne, though there is some speculation that it has been, perhaps, over-prescribed to patients whose conditions did not merit its use. It has been found that many patients' symptoms were not severe enough to require its use.
One of the more recent findings concerning the drug and its side effects is that people who have or had used the drug recently are four times more likely to suffer from gastrointestinal inflammatory disorders including ulcerative colitis and Crohn's disease. There has been no evidence suggesting a link between severe acne and these disorders, thus leaving the drug as the primary link in the findings.
Because of the link established between Isotretinoin and its side effects, many lawsuits have been brought against the manufacturers and medical care providers. Because Hoffman-La Roche has been found to be diligent in following the warning guidelines set forth by the FDA, few of the recent cases against them have been successful, however those who suffered the side effects prior to the required FDA warnings have had success in their cases. Cases against health care providers have a much greater success rate since it is the provider's responsibility to warn patients of all the risks they face before taking the medication.