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Isotretinoin (marketed as Accutane) Capsule Information
FDA ALERT [08/2005]: PREGNANCY: Strengthened Risk Management Program. FDA has approved a strengthened risk management plan for Accutane and generic isotretinoin to make sure females do not become pregnant while taking this medicine. Isotretinoin causes birth defects. This new plan is called iPLEDGE. Starting December 31, 2005 all:
wholesalers who distribute isotretinoin
doctors who prescribe isotretinoin
pharmacies that dispense isotretinoin
patients that take isotretinoin must register and agree to carry out the iPLEDGE program.
[07/2005]: SUICIDAL THOUGHTS OR ACTIONS: In addition to the strengthened risk management program for pregnancy, 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