NEW FDA APPROVAL FOR IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER..

Sirisha Pingali's picture
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FDA approved a new drug ABILIFY for Irritability associated with autistic disorder in Pediatric Patients of age 6 to 17 years.
Autism is a disorder of neural development that is characterized by impaired social interaction and communication, and by restricted and repetitive behavior. These signs all begin before a child is three years old.

SYMPTOMS:

Symptoms of autistic disorder includes aggression, deliberate self-injurious behaviors, temper tantrums and quickly changing moods.

DOSE:
ARIPIPRAZOLE is the main drug in ABILIFY and is an atypical antipsychotic. The recommended target dose of ABILIFY is 10 mg/day, as monotherapy or as adjunctive therapy with lithium or valproate. The starting daily dose of the tablet formulation in these patients was 2 mg/day, which was titrated to 5 mg/day after 2 days and to the target dose of 10 mg/day after 2 additional days. Subsequent dose increases should be administered in 5 mg/day increments. ABILIFY can be administered without regard to meals.

SOURCE: www.drugs.com@ news alerts

Supriya vavilapalli's picture

Dear sirisha, good

5

Dear sirisha,
good work...........

Supriya vavilapalli

THE COGNITIVE MOLECULES

http://www.pharmainfo.net/supriya-vavilapalli

Sirisha Pingali's picture

dear supriya.. Thank you for

dear supriya..
Thank you for your valuable comment.

V.B.S.Aishwarya's picture

Interesting Information

5

hi sirisha,
Its very interesting to know about Autism
What does temper tantrums mean?
Can meditation and interacting with them providing peacefulness can cure?
Regards,
Aishwaray

Sirisha Pingali's picture

dear aishwarya,, thank you

dear aishwarya,,
thank you for your valuable comment..
Temper tantrums are disruptive or undesirable behaviors or emotional outbursts displayed in response to unmet needs or desires. They may also refer to an inability to control emotions due to frustration or difficulty expressing a particular need or desire.
Infact autism is characterized in young children..infact Yoga can some what help in releiving some symptoms but its very difficult to make the children understand and ask them to concentrate on a particular thing.

Dr.S.Gunasakaran's picture

Nice Blog..

5

Dear Sirisha,

I like to add little information to your enlightening blog.

Previously, there is no approved treatment for the core symptoms of autistic disorder, irritability can be an associated behavior of autistic disorder and is manifested as aggression towards others, deliberate self-injurious behaviors, temper tantrums, aggression and quickly changing moods. Behavioral problems such as irritability can be a source of impairment or distress to an individual with autistic disorder.

Pharmacological treatment for pediatric patients with irritability associated with autistic disorder is indicated as part of a total treatment program that includes psychological, educational, and social interventions. The decision to initiate pharmacological treatment in children with irritability associated with autistic disorder should be made between healthcare providers and caregivers only after a thorough diagnostic evaluation and discussion of both the benefits and risks associated with pharmacological treatment. If treatment is initiated, American Psychiatric Association (APA) consensus guidelines recommend routine assessment and monitoring of patients’ weight, waist circumference, blood pressure, fasting plasma-glucose level and fasting lipid profile for the development of metabolic adverse effects.

The approval of ABILIFY for this indication is based on data from two eight-week, randomized, double-blind, placebo-controlled, multi-center, Phase III studies in which ABILIFY, compared to placebo, significantly improved scores on the Irritability subscale of the caregiver-rated Aberrant Behavior Checklist (ABC-I). The ABC-I subscale measured the emotional and behavioral symptoms of irritability in autistic disorder, including aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. Participating patients had a Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis of autistic disorder, confirmed by the Autism Diagnostic Interview-Revised, and exhibited behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems.

The efficacy of ABILIFY (aripiprazole) for the maintenance treatment of irritability associated with autistic disorder has not been evaluated. While there is no body of evidence available to answer the questions of how long the patient treated with ABILIFY should be maintained, patients should be periodically reassessed to determine the continued need for maintenance treatment.

Sirisha Pingali's picture

dear sir.. Thank you for your

dear sir..
Thank you for your valuable comment..Sir..You are absolutely right..The autism disease do not have any proper and complete treatment..Please keep posting your suggestions..

Zarrin Faria's picture

Dear...good efforts...which

5

Dear...good efforts...which company is manufacturing this brand?
Regards,
Faria Zarrin
Team: BLOGBUSTERS

Sirisha Pingali's picture

dear faria.. Thank you for

dear faria..
Thank you for your valuable comment,,
Bristol-Myers Squibb Co. and Otsuka America Pharmaceuticals Inc is manufacturing abilify.

Niklesh Rao V's picture

Good updation...keep

4

Good updation...keep posting...

Regards,
Niklesh Rao V
ATHARVANA

Sirisha Pingali's picture

dear nik.. Thank you for your

dear nik..
Thank you for your valuable comment..