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Drug Notebook

FDA Alerts

Special Alerts:

[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. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2006/safety06.htm#Isotretinoin, http://www.fda.gov/medwatch/safety/2006/accutane_ipledge.pdf, http://www.fda.gov/cder/drug/infopage/accutane/default.htm and http://www.fda.gov/cder/drug/infopage/accutane/FAQ200610.pdf.

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isotretinoin
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