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 Patrick Zenner, President and Chief Executive Officer, Hoffman-LaRoche Inc.
October 11, 2000
Patrick J. Zenner
President and CEO
Hoffmann-LaRoche Inc.
340 Kingsland Street
Nutley, New Jersey 07110
Dear Mr. Zenner:
We are very concerned about the recent reports of Accutane's (Isotretinoin) possible link to severe psychiatric side effects. We have written to Commissioner Henney asking her to take a series of actions with regard to Accutane and have enclosed this letter for your review. However, Hoffman-LaRoche can voluntarily take these actions without action by the Food and Drug Administration (FDA). 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, Hoffman-LaRoche 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.
In addition, we are very concerned about the lack of post market studies regarding Accutane and its link to suicide, suicide attempts, suicidal ideation and depression. Your company should immediately fund research on this urgent issue. Please work with the FDA to select and ensure independent studies are conducted in a valid scientific manner.
BART STUPAK
Member of Congress
