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Wed Mar 28, 2007 4:44 pm  |
Hi and FYI~
I subscribe to the FDA MedWatch email alert list. This was received today and wanted to pass the info along:
FDA - MedWatch - Accutane (isotretinoin)- Webpage Warning Against Buying Product and Generic Versions On Line
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
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.
Read the complete MedWatch 2007 Safety summary, including a link to the FDA Accutane Product Information Page regarding this issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Accutane |
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