Isotretinoin (marketed as Accutane) Capsule
FDA ALERT [05/2005]
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, 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. If the patient becomes irritable, anxious, has other symptoms of depression or has thoughts of suicide, they or their caregiver should contact their healthcare professional right away.
http://www.fda.gov/cder/drug/infopage/accutane/accutane-qa20041123.htm |