Data Summary:
Some of the
serious adverse event reports FDA has received regarding isotretinoin include
birth defects and psychiatric effects (i.e., suicide ideation and suicide). Isotretinoin is a well established teratogen. Although causality has not been established for isotretinoin and psychiatric events, the following information is important to consider:
Preclinical and neuroimaging data suggest that isotretinoin produces behavioral effects (i.e. activation) in rats, impairment of neuronal division in the murine hippocampus, and reductions in orbitofrontal brain metabolic rates in humans. This preclinical and neuroimaging data may suggest biological plausibility for the suspected psychiatric adverse events associated with isotretinoin.
From isotretinoin’s initial marketing in 1982 through August 2004, 4,992 spontaneous reports of
psychiatric disturbances associated with using isotretinoin in patients in the United States have been submitted to the FDA.
The number of reported suicides among isotretinoin users in the United States was 190 through January 2005. Between 1982 and 2002, there were 165 reported suicides, which were fewer than the 220 predicted based on U.S. vital statistics data. However, because the degree of under-reporting of suicides is unknown, the fact that the reported number is lower than the predicted number cannot be interpreted as evidence against a causal association.
All patients treated with isotretinoin should be observed closely for symptoms of depression or suicidal thoughts and referred to a specialist if necessary.
All patients should be informed to discontinue isotretinoin, and inform his/her healthcare professional right away if any of the following happens:
- Start to feel sad or have crying spells
- Lose interest in activities once enjoyed
- Sleep too much or have trouble sleeping
- Become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence)
- Have a change in appetite or body weight
- Have trouble concentrating
- Withdraw from family or friends
- Experience loss of energy
- Experience feelings of worthlessness or inappropriate guilt
- Start having thoughts of self-harm, or suicide
Discontinuation of the drug may not be sufficient; psychiatric evaluation and further intervention may be necessary.
Physicians are reminded that isotretinoin is marketed with a risk management plan to reduce fetal exposure to the drug. The goals of the program are that no woman should be given isotretinoin if she is pregnant and that no pregnancy should occur while a woman is taking isotretinoin.
I have just seen the dermatologist for my pimples. I was quite aghast by the price. $320! Yep. Anyway, I was intrigued by the drug Roaccutane. It's extremely vitamin A rich and costs $6 per pill. :) So, I went to search more infomation about it on-line. Apparently, it not only causes malformation in babies, but also depression by affecting activity in the frontal lobe of the brain. Haha.. Even without the medicine I am already depressed enough on my own. Will this cause my depression to worsen? I wonder. Let's just see shall we? Cher and her family left for Vancouver today. We spent the last evening at her house yesterday, till 10pm. She was busy answering her phone calls, while leng and I were busy fooling around and taking snap shots. We didn't cry today. I felt that the whole event was pretty surreal. I came back dead tired, but couldn't fall asleep. Then went to see the doctor since I couldn't sleep and wasn't going out in the afternoon anymore. I just felt too depressed to fall asleep? I'm slightly cheered up now after going out with Wy. We just strolled around Orchard. Yay! We're going to watch Madagascar on Tues :) I wonder if I have really gone nuts.
Cher & Leng