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Accutane FDA Alerts

The FDA Alerts below may be specifically about Accutane or relate to a group or class of drugs which include Accutane.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for Accutane

Accutane (isotretinoin) - Mar 28, 2007

[Posted 03/28/2007] FDA notified consumers and healthcare professionals of a special webpage launched to warn about the dangers of buying isotretinoin online. Isotretinoin is a drug approved for the treatment of severe acne that does not respond to other forms of treatment. If the drug is improperly used, it can cause severe side effects, including birth defects. Serious mental health problems have also been reported with isotretinoin use.

The new webpage, http://www.fda.gov/buyonline/accutane, will appear in online search results for Accutane (isotretinoin) or one of the generic versions, Amnesteem, Claravis, and Sotret. The webpage warns that the drug should only be taken under the close supervision of a physician or a pharmacist, and provides links to helpful information. The new webpage is in addition to special safeguards put in place by FDA and manufacturers of isotretinoin to reduce the risks of the drug, including a risk management program called iPLEDGE. The aim of iPLEDGE is to ensure that women using isotretinoin do not become pregnant, and that women who are pregnant do not use isotretinoin.


Accutane and generic isotretinoin - Oct 6, 2006

[Posted 10/06/2006] FDA and the iPLEDGE program notified healthcare professionals and patients of an update to iPLEDGE, a risk management program to reduce the risk of fetal exposure to isotretinoin, that will eliminate one element of the program, the 23 day lock-out period for males and females of non-child bearing potential. This change does not affect female patients of child-bearing potential.

[October 06, 2006 - Letter - iPLEDGE Program]
[October 06, 2006 - Drug Information Page - FDA]
[October 06, 2006 - Questions and Answers - FDA]

Isotretinoin - Accutane and generic isotretinoin - Oct 6, 2006

[Posted 10/06/2006] FDA and the iPLEDGE program notified healthcare professionals and patients of an update to iPLEDGE, a risk management program to reduce the risk of fetal exposure to isotretinoin, that will eliminate one element of the program, the 23 day lock-out period for males and females of non-child bearing potential. This change does not affect female patients of child-bearing potential.

[October 06, 2006 - Letter - iPLEDGE Program]
[October 06, 2006 - Drug Information Page - FDA]
[October 06, 2006 - Questions and Answers - FDA]

Accutane and generic isotretinoin - Aug 12, 2005

[Posted 08/12/2005] FDA notified healthcare professionals and patients of the approval of a strengthened risk management program, called iPLEDGE, for Accutane and generic isotretinoin. The strengthened program requires registration of wholesalers, prescribers, pharmacies and patients who agree to accept specific responsibilities designed to minimize pregnancy exposures in order to distribute, prescribe, dispense and use Accutane. In addition to approving the iPLEDGE program, FDA has approved changes to the existing warnings, patient information and informed consent document so that patients and prescribers can better identify and manage the risks of psychiatric symptoms and depression before and after prescribing isotretinoin..


Accutane (isotretinoin) - Nov 1, 2002

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.

[September 2002 Letter - Roche Laboratories]
[June 2002 Full, Revised Label, changes highlighted - Roche Laboratories]

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