FYI ----- Original Message ----- From: "CDER MEDWATCH LISTSERV" To: Sent: Friday, November 01, 2002 9:38 AM Subject: MedWatch - Revised safety labeling for Accutane > MedWatch - The FDA Safety Information and Adverse Event Reporting Program > > FDA and Roche revised the WARNINGS: Psychiatric Disorders, Boxed > CONTRAINDICATIONS AND WARNINGS, DOSAGE AND ADMINISTRATION, and PRECAUTIONS: > Drug Interactions sections of the prescribing information. Changes in > pediatric labeling were made to the CLINICAL PHARMACOLOGY: Special Patient > Populations: Pediatric Patients, WARNINGS: Skeletal: Bone Mineral Density, > and PRECAUTIONS: Pediatric Use: sections. > > Aggressive and/or violent behaviors have been added to the list of events > that Accutane may cause, based on post-marketing safety reports. No > mechanism of action has been established for these events. A new table has > been added to clarify those circumstances where pregnancy tests and Accutane > Qualification Stickers are applicable. Information specific to pediatric > patients has been added based on the results of recent studies conducted in > this patient population. A statement has been added regarding the long-term > use of Accutane advising that Accutane be given at the recommended doses for > no longer than the recommended duration. Prescribers were advised to > exercise caution when systemic corticosteroids or phenytoin are used with > Accutane. > > To see the MedWatch 2002 safety summary, including links to the Roche letter > and the revised, highlighted label, go to: > > http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#accuta > > -------- > > Thank you for using MedWatch as a trusted source for timely safety information on drugs and other medical products regulated by the U.S. Food and Drug Administration. If you find this e-mail notification helpful, please consider telling colleagues and friends about MedWatch. They can learn more about us and subscribe/unsubscribe to the e-list at the MedWatch homepage, http://www.fda.gov/medwatch or by going directly to http://list.nih.gov/cgi-bin/wa?SUBED1=medwatch&A=1 > > This is an automated message delivery system -- replying to this message will not reach MedWatch staff. If you have comments or questions about MedWatch or this e-mail, please contact us through our comments & feedback web page, http://www.fda.gov/medwatch/feedback.htm --- Outgoing mail is certified Virus Free. Checked by AVG anti-virus system (http://www.grisoft.com). Version: 6.0.393 / Virus Database: 223 - Release Date: 9/30/02