Accutane (Isotretinoin) entered the market in the US in 1982, and has been at the center of one firestorm after another ever since. It was never intended to treat a large number of patients. The FDA approved the drug for the treatment of severe nodular cystic acne, a type of acne that is painful, disfiguring, and will not respond to other forms of treatment.
The FDA approved labeling specifically points out that the drug is not to be considered a treatment of first choice:
"Because of significant adverse effects associated with its use, Accutane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics."
Alarmed by these reports, in September 1983, the non-profit consumer advocacy group, Public Citizen, submitted a petition to the FDA requesting patient package inserts and a black box warning label be added to Accutane describing the risk of birth defects and mental retardation.
Looking back, Public Citizen has been warning the FDA about the risks of serious harm to fetuses exposed to Accutane for more than 20 years. In 1984 the group sent a letter to the FDA advocating for improved pregnancy surveillance and lower dosing regimens.
The next year the group testified again and asked the FDA to withdraw isotretinoin from the market unless the previously proposed restrictions were adopted immediately.
In 1989, the CDC testified before an FDA Advisory Committee, and stated that the birth of babies with defects caused by fetal exposure to Accutane was unnecessary and called the FDA's decision to allow the marketing of Accutane, a "failed regulatory experiment."
At a December 11, 2002 House Oversight and Investigation Subcommittee hearing on the Safety Issues Relating to Accutane, internal documents from the nation's regulatory agencies were placed in the record that showed public health officials had been expressing serious concerns about Accutane and birth defects for well over a decade.
For instance, a 1990 internal FDA memo stated, "Accutane poses an imminent hazard to public health, and as such should be withdrawn immediately from the market."
A 1990 report by the FDA said, "The magnitude of fetal injury and death has been great and permanent, with 11,000 to 13,000 Accutane-related abortions and 900 to 1,100 Accutane birth defects."
In August 1997, the FDA issued a warning letter to Roche for failing to submit serious adverse event reports in a timely manner and Roche claimed its computer systems were responsible for delays of up to eight years in complying with the law.
A February 1998 FDA memo stated that Roche "had not acted in good faith to truly and accurately answer questions relating to Accutane use in women and pregnancy exposure."
The memo goes on to recommend "active consideration of removal of Accutane from the market."
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