ACCUTANE

Send Congressman Bart Stupak a Message at stupak.public.accutane@mail.house.gov
Please include your name, home address, zip code and phone number.

1. Stupak Response to FDA Advisory Panel Recommendations Regarding Mandatory Accutane Registry dated 2/27/04
2. Stupak Statement to FDA Advisory Panel Hearing on Accutane SMART Voluntary Registry dated 2/27/04 (PDF - 8 pages)
3. Congressman Bart Stupak's Statement
4. Background Information
5. FDA Memorandum dated 2/23/98
6. FDA "MedWatch" dated 2/26/98
7. FDA's Warning Letter to Roche dated 3/5/98
(PDF - 4 pages)
8. FDA's May 1, 2000 letter to Roche
(PDF - 16 pages)
9. Summary of Accutane Serious Adverse Events
(PDF - 21 pages 35KB)
10. Accutane Adverse Events Report
11. Roche Delivers Different Labeling In Same Box
12. Recommendations
13. Detailed Chronology
14. File an Adverse Event Report with FDA or call FDA @ 800-FDA-1088
15. Correspondence
16. Revised Informed Consent/Patient Agreement
(PDF - 3 pages 144KB)
17. Accutane Medication Guide
(PDF - 6 pages 792KB)
18. Other Accutane Links
19. Accutane Safety and Risk Management Act
     

Send Congressman Bart Stupak a Message at stupak.public.accutane@mail.house.gov
Please include your name, home address, zip code and phone number.