Abilify's FDA Approval HistoryIn September 2004, Abilify was approved to treat manic and mixed episodes, and in March 2005, further approval was granted for maintenance therapy in bipolar disorder. In October 2007, FDA approval was granted for treatment of schizophrenia in patients ages 13 to 17, and in November 2007, although Abilify is not an antidepressant, it was approved for the adjunctive treatment of adults with major depressive disorder. At that time, a new warning was added to the black box regarding suicidality and antidepressants in children, adolescents and young adults.
What Abilify is Used ForAbilify treats the same symptoms of schizophrenia as other drugs such as Zyprexa (olanzapine), Risperdal (risperidone) and Geodon (ziprasidone) - symptoms that are also found in manic episodes of bipolar disorder and in schizoaffective disorder. These include:
How Abilify WorksThe mechanism of Abilify is different from other medications used for the same symptoms. Most antipsychotics work by shutting down dopamine receptors; Abilify appears to work by forcing these receptors to behave more normally. In clinical trials, most patients lost a limited amount of weight on Abilify, which is an improvement over medications like Zyprexa; however, it should be noted that about five percent of patients gained seven percent or more of their initial body weight. Abilify was also found to be less likely than older antipsychotics to cause tardive dyskinesia.
Other important facts about Abilify
- It may be one to four weeks before you notice improvement of symptoms.
- Low blood pressure and lightheadedness can result. Do not take Abilify if you you have a cardiac condition.
- May cause drowsiness, so take the usual precautions regarding driving, etc., until you know how you will react.
- A higher dosage of Abilify may be needed if you are taking Tegretol (carbamazepine). This was not true of Depakote (valproic acid) or Lithium.
- A lower dosage of Abilify may be needed if you are taking Prozac (fluoxetine), Paxil (paroxetine) or other SSRI medications.
- Most common side effects were headache, anxiety, insomnia and nausea; however, these side effects were also the most common with placebo. In fact, although 20 percent of patients in clinical trials experienced anxiety with Abilify, 17 percent of those on placebo did, too.
- Do not drink alcohol while you are taking Abilify.
- Do not breastfeed when taking Abilify.
- If you experience rash or anxiety attack symptoms, contact your doctor immediately.
- Avoid overheating and dehydration.
- Animal studies suggest Abilify may cause birth defects. The manufacturer advises that Abilify should only be used during pregnancy if the potential benefits outweigh the risks to the fetus.
Abilify carries two standard black box warnings, one that appears on all antipsychotics, another that appears on all antidepressants:Warning #1 (Antipsychotics): Increased Mortality in Elderly Patients With Dementia-Related Psychosis
Full text of the warning, plus a plain English version of what it means.
Warning #2 (Antidepressants): Suicidality and Antidepressant Drugs
Text of this warning, along with a version in plain English and also other changes that were mandated by the US Food and Drug Administration.
Other CautionsRare cases of neuroleptic malignant syndrome (NMS) have been reported by patients taking Abilify. Review the symptoms of NMS and seek emergency help if you should experience them.
Hyperglycemia (high blood sugar) and diabetes have been reported with antipsychotic medications. At this time there are few reports of hyperglycemia in patients treated with Abilify, but the data are incomplete. Fasting blood-glucose monitoring should be done on all patients taking atypical antipsychotic medications.
Pediatric UseAbilify is now approved for adolescents aged 13 to 17, and is being studied for children below that age. Two chart reviews found that 67 to 71 percent of participants were either "improved" or "much improved," and found that Abilify was well-tolerated in the participating children and adolescents.
Financial AssistanceLike many newer medications, Abilify is very expensive, but you may qualify for the Abilify Patient Assistance Program. The earliest date the generic aripiprazole could become available is April 2015.
Disclaimer: This is not intended to be all-inclusive or to replace information provided by your doctor or with the prescription from the manufacturer.
Abilify.com. Abilify Approved Label. (PDF file).
Biederman, J., et al. "Aripiprazole in the treatment of pediatric bipolar disorder: a systematic chart review." CNS Spectrums 10(2005): 141-148.
Barzman, D., et al. "The effectiveness and tolerability of aripiprazole for pediatric bipolar disorders: a retrospective chart review." Journal of Child and Adolescent Psychopharmacology 14(2004): 593-600.