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Abilify Approved by FDA for Irritability Associated with Autism

The Food and Drug Administration has approved Abilify (aripiprazole) to treat irritability associated with autistic pediatric patients, ages six to 17. This includes treating temper tantrums, mood changes, aggression and self-injury. This FDA approval is based on two eight-week double-blind, multi-centered, placebo-controlled, and randomized Phase III studies. The FDA states that Abilify scored very well compared to the placebo in patients determined to have autism.

In addition to autism, Abilify is also used to treat acute depression in adults, bipolar disorder in children and adults, and schizophrenia. In some of these cases, Abilify is used in an adjunct capacity to buttress other medications, such as antipsychotics.

However, Abilify has certain known side effects that may make taking it dangerous. Elderly patients with dementia-related psychosis are more likely to die from cardiovascular events or infections, like pneumonia, than they are when treated with a placebo. Young adults and adolescents suffering from depression are more likely to have suicidal thoughts. It is noted that Abilify has not been approved for these two groups of these problems.

In addition, the boxed warnings include:

  • Hypersensitivity
  • Stroke or transient ischemic attack
  • Seizures
  • Motor and cognitive impairment
  • Reduced body temperature
  • Tardive dyskinesia
  • Hyperglycemia and diabetes mellitus
  • Dysphagia (aspiration pneumonia)
  • Orthostatic hypertension

These warnings are for all antipsychotics, including Abilify.

If you or a loved one has suffered detrimental side effects because of taking Abilify, please contact the experienced defective drug attorneys at Schlichter, Bogard & Denton for an initial consultation.

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