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January 12, 2017

Manufacturer Settlement for Abilify Unapproved Uses

Bristol-Myers Squibb To Pay $19.5 Million In Abilify® Settlement

Abilify (aripiprazole) is a popular antipsychotic medication manufactured by American drugmaker Bristol-Myers Squibb and marketed by the Otsuka Pharmaceutical Company. The U.S. Food and Drug Administration (FDA) approved Abilify to treat a variety of mental illnesses, including schizophrenia, major depression, bipolar disorder, Tourette Syndrome, and autism-related anxiety.

However, for the past 10 years, Bristol-Myers Squibb has faced numerous allegations and lawsuits claiming that it improperly promoted the drug to treat conditions for which it was not approved, and that it failed to warn patients and doctors of the potential of people developing metabolic side effects while taking Abilify.

In December 2016, despite denying any wrongdoing, Bristol-Myers Squibb agreed to pay a $19.5 million settlement to resolve the allegations levied against them in 42 states and the District of Columbia. If you were harmed by the off-label marketing of Abilify, or experienced serious metabolic side effects while on the drug, exploring your legal options can help you determine if you're eligible to pursue compensation for your injuries.

What Is Abilify?

Abilify is a second generation antipsychotic (SGA) drug that regulates the chemicals dopamine and serotonin in the brain. Unlike most of the drugs in its class, Abilify is actually able to increase or decrease dopamine or serotonin levels in response to a chemical imbalance. The FDA first approved Abilify in 2002.

To date, the FDA has approved the drug to treat the following mental health disorders in certain patient demographics:

  • Schizophrenia (in adult patients and adolescent patients ages 13 to 17)
  • Irritability associated with autism (in pediatric patients ages 6 to 17)
  • Bipolar disorder (with manic or mixed episodes, in adults as well as pediatric patients ages 10 to 17)
  • Tourette Syndrome (in pediatric patients ages 6 to 18)
  • Major depressive disorder (in adults who didn't respond to antidepressant medications alone)

Off-Label Promotion

Although the FDA approved Abilify to treat a number of mental health conditions, it's not indicated for—or approved to treat—all forms of mental illness. In fact, taking Abilify may have serious health consequences for patients with certain mental disorders. For example, in 2006, the FDA issued a “black box” warning for Abilify that warned consumers that the drug could increase the risk of death in patients with dementia.

However, numerous lawsuits against Bristol-Myers Squibb claim the well-known drugmaker touted Abilify as a treatment for pediatric patients with certain mental illnesses out of the tested age ranges; as well as elderly patients with dementia and Alzheimer's, even though the FDA has not approved the medication to treat these illnesses in the specified patient populations— a practice known as off-label promotion.

Failure to Warn of These Abilify Side Effects

The $19.5 million settlement announced in December 2016 also resolves claims that Bristol-Myers Squibb ran afoul of state consumer protection laws when it failed to fully warn patients and doctors of metabolic side effects associated with taking Abilify. These side effects include:

  • Metabolic weight gain (not explained by changes in diet, exercise, or lifestyle)
  • High blood sugar, also known as hyperglycemia
  • Diabetes
  • Increased cholesterol and triglycerides levels

Other Settlement Conditions

Paying $19.5 million isn't the only thing that Bristol-Myers Squibb has to do to make things right with the FDA and U.S. consumers. According to the terms of the settlement consent order, the company had to agree to only provide Abilify samples to doctors and other health care professionals whose patients have conditions that the drug is approved to treat. The company is also prohibited from promoting Abilify for off-label conditions, making false claims about the drug's side effects or efficacy, and must report clinical research accurately and objectively.

Did You Experience Serious Side Effects While Taking Abilify?

If you or someone you love suffered serious side effects after being prescribed Abilify for an off-label condition, or weren't sufficiently warned of potential metabolic side effects, contact McGartland Law today to schedule a free initial consultation. The experienced legal team with McGartland Law can discuss the details of your case with you and help you explore your legal options.

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