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