Linked to 240 suicides worldwide, Accutane side effects have been a controversial topic since its arrival to the U.S. market in 1982. An extremely powerful acne medication, Accutane was intended to treat only the most severe instances of nodulocystic acne. Due to the serious Accutane side effects associated to the drug, Accutane is supposed to be reserved only as a last resort treatment for severe acne.
Acknowledged as the most effective treatment for the severe, scarring form of acne, it is no wonder that Accutane has become Hoffmann-La Roche's top-selling product, used by an estimated 5 million Americans alone. The cure for acne may have come at a price, though, as families and Accutane patients wonder why the manufacturer has failed to adequately warn of the deadly Accutane side effects that can occur. Families of suicide victims are now filing Accutane lawsuits, in addition to some Accutane users who have developed inflammatory bowel disease and lupus that they claim is the result of using Accutane.
Psychiatric Disorders
The reports of psychiatric disorders in Accutane users, including suicide, were repeatedly denied to have any link by the Accutane manufacturer. Accutane was portrayed not as an increased risk for psychiatric disorders such as depression, rather as quite the opposite. Roche tried to imply that acne causes feelings of depression and the use of Accutane may relieve such feelings when helping to treat it. Even after the FDA issued a "Dear Doctor" letter in the beginning of 1998, warning physicians of links between Accutane and "depression, psychosis, and rarely, suicidal ideation, suicide attempts and suicide" and had Roche strengthen warnings to reflect these effects, the company was issued a warning letter after the FDA found the Accutane promotional advertisements to contain "false and misleading" information.
Several studies have suggested a possible link between isotretinoin and clinical depression. The argument that isotretinoin caused depression and suicide has won a few lawsuits, and is partially responsible for the strict control of the drug, especially in the US. Various case reports of depression, suicidal ideation, suicide attempt, and suicide in patients treated with isotretinoin have been reported to the U.S. FDA Adverse Events Reporting System, with 431 cases reported between 1982 and May 2001 - of these 37 patients had committed suicide. While analyses have suggested an association between isotretinoin therapy and depression, no causal relationship has been established and further studies are required.
U.S. Representative Bart Stupak (D-MI) is known for his distrust of Accutane. He believes unadvertised psychological side effects from the drug drove his teenage son, Bartholomew Thomas "B.J" Stupak Jr., to commit suicide in 2000.
David Graham, an FDA scientist, described Accutane as "a 20-year regulatory failure by the FDA." The acne medication can cause miscarriage and birth defects when taken by pregnant women. Even with the risk-management system SMART (System to Manage Accutane-Related Teratogenicity), which did not go into effect until 2000 to better manage Accutane's safety issues in women, Graham said the system has not been adequate, saying "In my view, SMART was dumb."
