Accutane
Letter from Representatives Bart Stupak (D-MI), Henry Waxman (D-CA), Tom Barrett (D-WI), Sherrod Brown (D-OH), Marge Roukema (R-NJ), Tom Coburn, M.D. (R-OK), Representative Zach Wamp (R-TN), Representative Ed Bryant (R-TN) to Jane Henney, Commissioner Food and Drug Administration.
October 11, 2000
The Honorable Jane Henney
Commissioner
Parklawn Building
5600 Fishers Lane
Rockville, MD 20857
Dear Commissioner Henney:
We are very concerned about the recent reports of Accutane's (Isotretinoin) possible link to severe psychiatric side effects. We urge you to take swift action on a number of steps to protect the public health.
As the Today show segment that aired last week proved, the public has not received adequate information regarding the serious adverse psychiatric effects that may be associated with Accutane. In order to immediately increase public awareness, the FDA should:
- require all Accutane patients receive and sign an informed consent form clearly warning of Accutane's risks of depression, suicide and other psychiatric disorders every time the physician prescribes the drug; and
- immediately ensure that Accutane labeling and boxes display the same warnings as the physician package insert of Accutane's risks of birth defects and of depression, suicide and other psychiatric disorders; and
- immediate issue a patient "MedGuide" with clear and prominent warnings of Accutane's risks of birth defects and of depression, suicide and other psychiatric disorders.
In addition, we are urging Hoffman-LaRoche to take a number of steps and we ask that you use any resources available to the FDA to ensure its cooperation. First, we are very concerned about the lack of post market studies regarding Accutane and its link to suicide, suicide attempts, suicidal ideation and depression. Please work with Hoffman-LaRoche to select and ensure independent studies are conducted in a valid scientific manner.
BART STUPAK
Member of Congress
