They are swollen please help ??!


Question:

They are swollen please help ??

hi there, i have been on roaccutane for 4 months now. It has caused my lips to swell, (a side affect of roaccutane). I have come of roaccutane today and how long will it take my lips to get back to normal ? ie swelling to go down ???. This is getting to me big time so what could i do as roaccutane stays in the system for 6months after you have gone off it. please help


Answers:

Frequently reported reactions were:

• skin disorders (18% of total) e.g. rash, dry skin and photosensitivity.
• musculoskeletal disorders (11%) e.g. myalgia and arthralgia.
• gastrointestinal disorders (10%) e.g. cheilitis, abdominal pain and dry mouth.
• eye disorders (7%) e.g. conjunctivitis, dry eyes and blurred vision.
• neurological disorders (7%) e.g. migraine and convulsions.

Psychiatric disorders
Five percent of all reported ADRs to Roaccutane are psychiatric reactions including depression and rarely suicide and attempted suicide. Product information for Roaccutane has been amended to strengthen warnings about depression and the possibility of suicide. Doctors are advised to monitor patients for signs of depression.

FDA Warning of suicide and depression risk issued in the USA June and December 2005 as follows:
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.




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