FDA blurb on accutane:
iPLEDGE Update (10/6/2006): FDA is providing an update about iPLEDGE, a risk management program to reduce the risk of fetal exposure to isotretinoin (a drug to treat severe recalcitrant nodular acne). Today’s change will eliminate one element of the program, the 23 day lock-out period for males and females of non-child bearing potential (FNCBP). Previously, all patients prescribed isotretinoin had to fill their prescription within 7 days of their office visit. Patients who missed this window of opportunity and attempted to fill their prescription after 7 days had elapsed could not receive isotretinoin for another 23 days, a provision designed to prevent potential exposure to the drug during pregnancy. The elimination of the 23 day lock-out period for males and FNCBP will allow these patients the ability to have a new prescription filled immediately after the 7 day window has expired. This change does not affect female patients of child-bearing potential, and the iPLEDGE call center cannot authorize exceptions. Questions and Answers regarding iPLEDGE can be viewed at
Code:
http://www.fda.gov/cder/drug/infopage/accutane/FAQ200610.pdf.
FDA ALERT [11/2005]: Start Dates Have Been Changed for the iPLEDGE Program. FDA approved a strengthened risk management plan for Accutane and generic isotretinoin on August 12, 2005, to make sure females do not become pregnant while taking this medicine. Isotretinoin causes birth defects. This new plan is called iPLEDGE. The iPLEDGE program was originally scheduled to begin on November 1, 2005. To allow more time for registration and activation, the implementation dates of the iPLEDGE program have been revised. The start date by which wholesalers and pharmacies must be registered /activated in iPLEDGE has been changed from November 1, 2005 to December 30, 2005. The starting date to begin patient registration and qualification in iPLEDGE has been changed from November 1, 2005 to December 30, 2005. By March 1, 2006, only prescribers registered and activated in iPLEDGE will be able to prescribe isotretinoin and only patients registered and qualified in iPLEDGE will be able to be dispensed isotretinoin.
FDA ALERT [7/2005]: Suicidal Thoughts or Actions: In addition to the strengthened risk management program, FDA continues to assess reports of suicide or suicide attempts associated with the use of isotretinoin. All patients treated with isotretinoin should be observed closely for symptoms of depression or suicidal thoughts, such as sad mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating, or for mood disturbance, psychosis, or aggression. Patients should stop isotretinoin and they or their caregiver should contact their healthcare professional right away if the patient has any of the previously mentioned symptoms. Discontinuation of treatment may be insufficient and further evaluation may be necessary. [Action taken 08/12/05 Labeling revision]
This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.