Interesting...and there has just been another change to Abilify’s label on 7/19/09 (not available online yet).

Since its approval 11/15/02, there have been 11 Labeling Revision’s; not including 5 New or Modified Indications and 2 for Altered Patient Populations.

The initial label was 25 pages, the most recent available on line (8/14/08) is 72 pages long.

On 2/27/08, it was approved to treat Bipolar I Disorder in pediatric patients aged 10 to 17. The requirement for pediatric studies has been waived (5/6/08 letter).

On 3/6/08 this was added under ADVERSE REACTIONS:

Clinical Studies Experience

Dystonia
Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue… An elevated risk of acute dystonia is observed in males and YOUNGER age groups

On 8/14/08; a boxed warning was added regarding an increased risk of death based on information from trials that lasted just 10 WEEKS:

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%...

I wonder if their dementia-related psychosis was caused by Abilify. Dementia is listed as a possible side-effect.

Abilify- was on it for 9 months. My life sucked for that entire 9 months. I didn't feel good or bad, I just didn't feel anything. I know euthymia, and THAT was not euthymia.

Two words: Abilify sucks!

Just wait till these soccer moms who've been asking their docs ( because of the slick ads) for Abilify begin to experience drug-induced psychosis. Perhaps then, this drug from hell will lose some of its shine.