WARNING SIDE EFFECTS
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
FDA ALERT [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]
 $7 Million Verdict Upheld in Accutane Lawsuit houston.injuryboard.com
February 18, 2008 - 02:15 PM
Drug giant Roche has been ordered to pay a $7 million verdict to man
who had to have his colon removed after taking the popular acne
medication Accutane. This is the second loss for Roche in as many trials
for Accutane. Roche still faces over 400 lawsuits alleging that Accutane
caused Crohn's disease.