Drug Warning: Abilify

Generic name: aripiprazole (a second-generation or atypical antipsychotics)
Manufactured and marketed by: Bristol Myers Squibb

Purpose: Is prescribed for the treatment of symptoms associated with schizophrenia and bipolar I disorder. Symptoms of schizophrenia that Abilify is used to treat may include hearing voices or seeing things that are not there, while bipolar I symptoms for which Abilify is prescribed include the manic episodes associated with this mood disorder.

Side Effects Reported

• The common side effects of Abilify may include headache, nausea, vomiting, constipation, sleeplessness, restlessness, anxiety, dizziness, and rash.
• Abilify may be linked to significantly more harmful side effects such as the major health risks of neuroleptic malignant syndrome (NMS), tardive dyskinesia (TD), stroke and ministroke, diabetes, and high blood sugar (hyperglycemia).
• A clinical study has reported that there exists an increased risk of stroke and ministroke in elderly patients with dementia-related psychosis who are treated with atypical antipsychotics.
• Atypical antipsychotics in general have been linked to increasing the risk of obesity and high cholesterol, as well as diabetes in those to whom they are prescribed.
• The risk of diabetes is increased further in those that have additional diabetes risk factors such as preexisting obesity or a family history of diabetes.

Industry Report

The FDA has requested that manufacturers of atypical antipsychotics, including the producer of Abilify, Bristol-Myers Squibb, include a warning about the risks of diabetes on its labeling. In addition, these effects of obesity, high cholesterol, and diabetes, are believed to be contributing factors that may increase the risk of developing heart disease or other serious cardiovascular problems.

The FDA indicated in 2005 that in recent trials, older patients treated for dementia with atypical antipsychotics had an increased risk of death when compared to patients in a placebo control group who did not take the atypical antipsychotics. Most of the deaths appear to have been caused by heart related ailments such as heart disease and infections like pneumonia. The FDA has ordered manufacturers of atypical antipsychotics to include a new warning about the increased risk of death to elderly patients with dementia as a "black box warning.”

Seeger Weiss is not currently pursuing lawsuits on this drug, but its drug warnings will remain on our radar.

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