ABILIFY® Linked to Increased Risk of Type-2 Diabetes In Children and Adolescents

If your child developed Type-2 Diabetes on ABILIFY® you or your child may be entitled to compensation

Antipsychotic Medications

Two types of anti-psychotics:

  • “Traditional” or “First Generation”
    • Treats schizophrenic hallucinations, jumbled speech, illogical thoughts, etc.
  • “Atypical” or “Second generation”
    • Treats all of the above, and social symptoms: social withdrawal, blunted emotions
    • Includes Abilify

Abilify (Aripiprazole)

  • Abilify is an “atypical” antipsychotic developed by Otsuka, a Japanese pharmaceutical company.
  • Jointly promoted to the US market with Bristol-Meyers Squibb.
  • Whereas most antipsychotics work by shutting down dopamine receptors, Abilify works by rewiring them.

Abilify: Regulatory History

  • Nov. 2002: FDA approval for treatment of schizophrenia
  • March 2005: approval for bipolar
  • Nov. 2007: approval as add-on treatment for depression
  • Feb. & May 2008: approval for adolescent bipolar & schizophrenia
  • Nov. 2009: approval for autism irritability
  • Sept. 2007: Bristol-Meyers Squibb pays over $515 million to settle DOJ charges for illegal drug marketing
  • Abilify charges:
    • Settlement disgorged over $25 million in profit from illegally marketing Abilify to children and geriatric patients
    • A portion of the larger fine also attributed to Abilify violations
  • Today, over 500,000 children are being given antipsychotics.
    • 3 documented cases of children under 1 year old treated with antipsychotics.
  • Several studies have confirmed a link between antipsychotics and Type 2 diabetes in adults.
  • Until last year, there was no study showing a diabetes risk for youth.

Studies: Link Between Abilify & Type 2 Diabetes

  • 2004 study sponsored by Bristol-Meyers Squibb:4
    • Says other antipsychotics increase risk of Type 2 diabetes, but Abilify has “no effect” on risk in adults.
  • 2013 study of youths in Medicaid:5
    • Antipsychotics triple the risk of Type 2 in youths.

2013 Medicaid Youth Study: All Antipsychotics

For all antipsychotics, risk of diabetes in youth increases with dosage:

  • 2.1 times the risk at low doses.
  • 3.4 times the risk at medium doses.
  • 5.4 times the risk at high doses.

Abilify Had the Highest Risk of Any Antipsychotic

  • The highest doses of other antipsychotics increased risk 5.4 times above normal.
  • Average doses of Abilify increased diabetes risk 7.72 times above normal.

Risk Stayed High for a Year After Patients Stopped Treatment

  • After a year, patients still had 2.57 times the normal risk.
  • May stay elevated even longer – patients were released from the study 365 days after ending medication.
  • In 2004, Bristol-Meyers Squibb added the warning to “check blood glucose levels” to screen for warning signs.
  • The study showed that the warning had no statistical effect on the rate of diabetes.

2013 Medicaid Youth Study: All Antipsychotics

Total odds of diabetes increase with treatment time:

  • After 1 year, 1 in 500 will develop diabetes.
  • After 2 years, 1 in 222 will develop diabetes.
  • After 3 years, 1 in 133 will develop diabetes.
  • After 4 years, 1 in 91 will develop diabetes.

What does a diagnosis of type 2 diabetes mean?

  • Can’t you just take insulin?
  • Can’t you just exercise, like Geofabio®?
  • Diabetes can be prevented with lifestyle changes and medication.
  • It cannot be cured once it develops.
  • The body’s ability to produce insulin is permanently damaged.
  • After a diagnosis, dramatic lifestyle changes can only reduce the need for insulin injections and prevent further damage.

Diabetes & Quality of Life

Blood vessel damage causes tissue death:

  • Amputations: 65,700 in 2006 alone
  • Ulcers that will not heal
  • 28.5% of diabetics develop impaired vision
  • Diabetes is the leading cause of blindness among adults age 20-74
  • Kidney Failure: leading cause is diabetes
  • Stroke: 2 to 4 times as likely
  • Heart Disease: 2 to 4 times as likely
  • Sexual Dysfunction: 2 to 3 times more likely to have erectile dysfunction, and have it 10-15 years earlier
  • Pregnancy Complications: including miscarriage and birth defects
  • Numbness: 60-70% of all patients

Life Expectancy

“Life expectancy is reduced, on average, more than 20 years in people… [who] develop diabetes at a younger age” – Diabetes UK

Higher Costs, Lower Income

  • Average American annual healthcare expenses: $6,815
  • Average diabetic annual healthcare expenses: $13,700

Income gap:

  • Diabetics earn $160,000 less over their lifetime, on average.

Causes:

  • More likely to drop out
  • More likely to be unemployed
  • Time missed from work
  • Premature death