Accutane and Crohn's Disease

Accutane Isotretinoin
WARNING SIDE EFFECTS zhion@zhion.com November 05, 2005

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.

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]

This information reflects FDAÂ’s preliminary analysis of data
concerning this drug. FDA is considering, but has not reached a
final conclusion about, this information.

[1] $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.[1]