Accutane Warning Labels
Since its release in 1982 there has been a controversial history to accutane, its side effects and the information provided with the drug. Accutane's manufacturer has long been under pressure to provide details regarding the alleged side effects
of the product, making them comply has been a long strugle.
Currently the warning on accutane states:
"..Mental problems and suicide. Some patients have become depressed or developed other serious mental problems while they were taking Accutane or shortly after stopping Accutane. Some patients taking Accutane have had thoughts of ending their own lives (suicidal thoughts). Some people have tried to end their own lives (attempted suicide) and some people have ended their own lives (committed suicide).
There have been reports of patients on
Accutane becoming aggressive or violent. No one knows if
Accutane caused these problems or behaviors or if they would have happened even if the person did not take
Accutane.."
Below we look at the history leading to todays accuatane labelling.
1971
Hoffman La-Roche (Roche) develops Accutane, but chooses not to pursue marketing because of its risk of birth defects.
June 1982
The Food and Drug Administration (FDA) approves Accutane for the treatment of severe cystic acne which is unresponsive to other treatments. Shortly after marketing, FDA and Roche receive reports of Accutane-related birth defects.
September 1983
Public Citizen, a consumer advocacy group, petitions FDA for warning labels on Accutane's risk of birth defects and other side effects.
March and October 1984
FDA requires stronger warnings and physician mailings on Accutane's risk of birth defects.
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."
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