The lawsuit (PDF) alleges that Bristol-Myers Squibb Co. and Otsuka American Pharmaceutical Inc. in the U.S. District Court for the Southern District of New York.
Defendants are accused of failing to warn doctors and patients that children who take the average recommended dose of Abilify are 7.7-times more likely to be diagnosed with type-2 diabetes.
The plaintiff, Cheyenne Beth Confer, says she was 15 years old when she was prescribed Abilify in May 2009. The prescription was “off-label” for the treatment of depression. Six months later, she had gained 30 pounds and was diagnosed with diabetes. She now must take metformin to control the disease.
The Prescribing Information for Abilify includes general warnings about the possible risk of hyperglycemia (high blood sugar) and type-2 diabetes associated with anti-psychotic drugs in adults.
However, for children and teenagers, the manufacturer only includes data from placebo-controlled studies in children with schizophrenia, bipolar disorder, and more. None of these studies found changes in fasting blood-sugar (glucose) levels.
According to the lawsuit, the Prescribing Information is outdated because it does not include information from studies published since at least 2005. These studies suggest that children are more sensitive to the drug’s metabolic affects and are more likely to gain weight at a faster rate than adults. Rapid weight-gain is a risk-factor for diabetes.
The complaint also alleges that Abilify was aggressively promoted for “off-label” use in children. In September 2007, the U.S. Department of Justice (DOJ) announced that Bristol-Myers Squibb Co. had agreed to pay $515 million to resolve a broad array of allegations involving marketing, including knowingly promoting Abilify for pediatric uses between 2002 and 2005.