FDA Warnings for Abilify (Aripiprazole)

HIGHLIGHTS OF PRESCRIBING INFORMATION FOR ABILIFY (ARIPIPRAZOLE)M THE ANTI-PSCYHOTIC MEDICATION

These highlights do not include all the information needed to use ABILIFY safely and effectively. See full prescribing information for ABILIFY.

ABILIFY® (aripiprazole) Tablets

ABILIFY DISCMELT® (aripiprazole) Orally Disintegrating Tablets

ABILIFY® (aripiprazole) Oral Solution

ABILIFY® (aripiprazole) Injection FOR INTRAMUSCULAR USE ONLY

Initial U.S. Approval: 2002

BLACK BOX WARNING:

WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED

PSYCHOSIS and SUICIDALITY AND ANTIDEPRESSANT DRUGS

See full prescribing information for complete boxed warning.

• Elderly patients with dementia-related psychosis treated with antipsychotic

drugs are at an increased risk of death. ABILIFY is not approved for the

treatment of patients with dementia-related psychosis. (5.1)

• Children, adolescents, and young adults taking antidepressants for Major

Depressive Disorder (MDD) and other psychiatric disorders are at increased

risk of suicidal thinking and behavior. (5.2)

 

- – - – - – - – - – - – - – - – RECENT MAJOR CHANGES – - – - – - – - – - –

Boxed Warning, Suicidality and Antidepressant Drugs 11/2007

Boxed Warning, Increased Mortality in Elderly Patients with Dementia-Related Psychosis 08/2008

Indications and Usage, Adolescent (13 to 17 years) Schizophrenia (1.1) 05/2008

Adjunctive Therapy (Lithium or Valproate) in Adult and 05/2008

Pediatric (10 to 17 years) Patients with Bipolar Mania (1.2)

Pediatric (10 to 17 years) Bipolar Mania (1.2) 05/2008

Adjunctive Treatment in Adults with MDD (1.3) 11/2007

Dosage and Administration, Adolescent Schizophrenia (2.1) 05/2008

15 mg starting dose in Bipolar Mania (2.2) 05/2008

Adjunctive Therapy (Lithium or Valproate) in Adult and 05/2008

Pediatric Patients with Bipolar Mania (2.2)

Pediatric Bipolar Mania (2.2) 05/2008

Adjunctive Treatment in Adults with MDD (2.3) 11/2007

Warnings and Precautions, Clinical Worsening of Depression and Suicide Risk (5.2) 11/2007

 

- – - – - – - – - – - – - – - – - ADVERSE REACTIONS – - – - – - – - – - – -

Commonly observed adverse reactions (incidence ≥5% and at least twice that for

placebo) were (6.2):

  • Adult patients with Schizophrenia: akathisia
  • Pediatric patients (13 to 17 years) with Schizophrenia: extrapyramidal disorder,

somnolence, and tremor

  • Adult patients (monotherapy) with Bipolar Mania: akathisia, sedation, restlessness,

tremor, and extrapyramidal disorder

  • Adult patients (adjunctive therapy with lithium or valproate) with Bipolar Mania:

akathisia, insomnia, and extrapyramidal disorder

  • Pediatric patients (10 to 17 years) with Bipolar Mania: somnolence, extrapyramidal

disorder, fatigue, nausea, akathisia, blurred vision, salivary hypersecretion,

and dizziness

  • Adult patients with Major Depressive Disorder (adjunctive treatment to antidepressant

therapy): akathisia, restlessness, insomnia, constipation, fatigue, and

blurred vision

  • Adult patients with agitation associated with Schizophrenia or Bipolar Mania:

Nausea

 For full side effects click on the “Abilify” link to your left on this page.

- – - – - – - – - – - – - – WARNINGS AND PRECAUTIONS – - – - – - – - – - – - – - -

  • Elderly Patients with Dementia-Related Psychosis: Increased incidence of

cerebrovascular adverse events (eg, stroke, transient ischemic attack, including

fatalities) (5.1)

  • Suicidality and Antidepressants: Increased risk of suicidality in children,

adolescents, and young adults with Major Depressive Disorder (5.2)

  • Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and

close monitoring (5.3)

  • Tardive Dyskinesia: Discontinue if clinically appropriate (5.4)
  • Hyperglycemia and Diabetes Mellitus: Monitor glucose regularly in patients with

and at risk for diabetes (5.5)

  • Orthostatic Hypotension: Use with caution in patients with known cardiovascular

or cerebrovascular disease (5.6)

  • Seizures/Convulsions: Use cautiously in patients with a history of seizures or with

conditions that lower the seizure threshold (5.7)

  • Potential for Cognitive and Motor Impairment: Use caution when operating

machinery – 5.8

  • Suicide: The possibility of a suicide attempt is inherent in Schizophrenia and

Bipolar Disorder. Closely supervise high-risk patients (5.10)

This list is a small portion of the warnngs on the FDA’s website.  You decide if you want to take the risk with your own life.  But if you are depressed you just might.  Huh?

To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch and leave a comment on this blog for all to see.

All information posted in this writing is the opinion of the author and is provided for educational purposes only.  It is not to be construed as medical advice.  Only a licensed medical doctor can legally offer medical advice in the United States.  Consult the healer of your choice for medical care and advice.

 

 

This website may contain some copyrighted material. We reserve the right to reproduce such material under the Copyright Act, Title 17 US Code, Section 107, “Fair Use”, as we believe the public should be informed of such information so they can think for themselves rather than rely on advertisements and the word of others.http://www.copyright.gov/title17/92chap1.html#107

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15 Responses to “FDA Warnings for Abilify (Aripiprazole)”

  1. Bridgett Simon Says:

    I am a 50 yr. old female that started taking the drug Abilify. I started taking the drug in I guess in 2005. I been gambling
    since that time. I gamble everyday for 3 years. I was obsess
    with gambling. When I went to bed at night I gamble in my dreams. I went to Dr. and complain about my gambling, he increased the dosage. The gambling only got worse. I lost my Job, that I had for 26 yrs. I lost everything except my soul. My marraige was bad, I had just got married, that yr. I shoped compulsively, I life was ruined, I thought I would die gambling. I felt suisidual. I quit grooming myself, all I wanted to do was gamble. I beg friends and family for money, even strangers. I even stole money. I went through my retirement. I could not hold down job. Gambling was my life. One day I hit rock botton, I had no money to go to Dr. I had no Abilify, in about 3 to 4 days I notice a change in my bahavior. I did not have a strong craving to gamble. I quest that was in, about oct. of 2008. I have not gamble since. That when I figure out it was the Abilify. I feel like God has smiled on my he set me free. Bridgett Simon 409-540-0460 feel free to call me. My email is vernonjazz@aol.com

    • papahoser1 Says:

      Hi, Bridgett:
      I went through this same experience, (gambling), shortly after beginning the Abilify. If there is anybody out there who has endured this similar nightmarish experience, PLEASE contact me, as I desparately need to speak to someone about it. My contact info: Joe Ridings 541-913-0644 or e-mail fjridings@yahoo.com Thank-you

  2. Darla Says:

    My Mother has been on abilify and has been gambling way to much. She never gambled before thought it was a waste of her money and then she started and it has gotten really bad We have had her in to see dr. and finally one said that Abilify has been linked to gambling and has taken her off it. Do not know how she will be this has just happened

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  4. James Penn Says:

    My wife was not a gambler before becoming a psychiatric patient. She takes prescribed Abilify. Since somewhere early in her treatment, she has been gambling. She can’t control it. Impact of losing money we can’t afford to lose doesn’t outweigh the need to gamble. It’s amazing to observe.

    Today, a couple of years after this phenomenon began, I began researching her medications and gambling.

    She also moves her tongue around the insides of her cheeks almost incessantly, and she carries her left arm, hand and fingers in a strange position, like she’s holding a pistol. I am not implying any tendency to hold a firearm. I’m just saying that’s the position the arm, hand, and fingers have defaulted to. She never used to exhibit any of these conditions.

    • Kev Says:

      James,
      Please contact me ASAP, as I too experienced compulsive gambling as a result of taking Abilify. Much research has now been done linking abilify to compulsive gambling. I am now compiling a list of individuals who have developed compulsive gambling due to taking abilify. Please contact me ASAP:

      gambilify@gmail.com

      Kevin

  5. cindy Says:

    my husband has same problem since he on abilify .His doctor doesnt believe me. He lost so much already. I would like to see more people to report this problem. I dont want to see this happen to another person

  6. C A Says:

    my husband had same problem since he on abilify.Really his doctor did not believe me for years.My husband did not believe me,too because of his doctor. Now we owe so much money because of Abilify. Two months ago, I gave my husband 2 choices,Change pill or divorce? He changes his pill and now he is back to normal but we have so much to pay back.

  7. gary Says:

    my 22yr old son has been on abilify 15 mg for 3yrs for treating tourettes and has become a problem gambler the situation got so bad we went to see a specialist in london. we were shocked to be told that this drug is known to cause gambling problems
    i cant believe this is not on the side affects list on the leaflet we shall be stopping the meds soon i shall report back
    best wishes to all
    gary
    pls feel free to contact me for our experiences

    • Kev Dru Says:

      Gary,

      Please contact me. I would be interested in speaking with you about your son’s experience. I also began to gamble only after taking Abilify. Please let me know what the specialist in London said. Email me at:
      Gambilify@gmail.com

      Thanks!

  8. Anonymous Says:

    Hello everyone! I have the same problem. I controled gambling before… During abilify curation I cannot control. I can play to lose last dollars..

    I need to talk with someone with the same problem.

    my email adress :crazyfrog90@interia.pl

  9. C A Says:

    Update: my husband doing so good after he stop the Abilify 8 months ago. No more gambling for him. My husband and his doctor should believe me years ago. We are paying the debt everyday because of Abilify but at least my husband is back to normal after almost 10 years abilify ruinned our life.

  10. Anonymous Says:

    My husband became a pathological gambler after taking abilify. It was not until I did a google search and found these posts, other posts and case studies that we connected the drug to his gambling problem (which did not begin until after he began taking the drug). After he quit taking Abilify, the urge to gamble decreased within days. After a couple of weeks (once the drug had left his system), he quit completely. He no longer has the urge or desire to gamble. It was the difference between night and day!
    We know for a fact that this drug was the cause of his gambling addiction. He could not stop thinking about gambling. He often played for free online…he just HAD to play! If you or someone you know developed pathological gambling from taking abilify (aripiprazole), please email us as soon as possible. We would be interested in hearing your story!
    We set up an email just for correspondence about Abilify. Please email us at: gambilify@gmail.com

    We pray that others who have not yet made the connection between their gambling problem and Abilify find these posts and case studies, as we have. If your gambling problem disappears after ceasing this medication….that’s your proof! Good luck to you!

  11. Anonymous Says:

    My son was 17 yr old when he was prescribed abilify for his Tourettes. He never had a gambling problem while on it, I wish that was his only problem. Since then, he has about 100 new symptoms, which include OCD, ADD and fears and fobias! He was never mentally ill before taking the drug. It should not be prescribed to children under 18. it ruined his life


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