Accutane's Historical Timeline
1971:
Roche created Roaccutane, marketed as Accutane in the USA.
1982:
FDA approves Accutane as a drug designed to treat severe cystic acne.
June 1985
Roche amends Accutane's package insert under 'Adverse Reactions' to state:
"The following CNS reactions have been reported and may bear no relationship to therapy - seizures, emotional instability including depression, dizziness, nervousness, drowsiness, malaise, weakness, insomnia, lethargy and paresthesias."
1986:
After only 4 years on the market accutane's packaging information is updated to include a warning stating that depression had been recorded as a side effect by some users.
1988:
Non profit public interest “Public Citizen” commences petition for a ban on the sale of Accutane.
Godfrey Oakley, director of the Division of Birth Defects and Developmental Disabilities at the Centers for Disease Control, wrote that "40 infants born alive after first trimester exposure to Accutane have died ... because of the developmental errors that Accutane caused." Oakley argued that "we simply need to remove the drug from the market."
1990:
14 years before his recent Senate testimony, FDA scientist David Graham wrote; Accutane "cannot safely be given to women of childbearing age or potential" because the drug causes birth defects and results in abortions among women unwilling to give birth to children with deformities. There is no alternative to immediate withdrawal of Accutane from the market. To delay only compounds the body count."
1990
In a 1990 memo, FDA concluded that as a result of Accutane's risks of birth defects, "The magnitude of injury and death has been great and permanent, with 11,000 to 13,000 Accutane-related abortions and 900 to 1,100 Accutane-related birth defects."
1994:
An FDA memo of a telephone conference with Roche showed the firm had reviewed reports of suicide and depression related to Accutane and had "concurred that there does appear to be a problem."
1997:
In France Roche is forced to list suicide on the list of potential side effects. A Roche doctor recommends that users are monitored for signs of depression and taken off their treatment if necessary.
August 1997
FDA issues a warning letter to Roche for failing to submit serious adverse event reports in a timely manner. Roche claims its computer systems are responsible for delays of up to eight years in complying with the law.
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