September 9, 2014 — A lawsuit has been filed in federal court in New York by a woman who was prescribed Abilify (aripiprazole) as a child and subsequently developed type-2 diabetes, according to Law360.
The lawsuit (PDF) was filed in the U.S. District Court for the Southern District of New York against Bristol-Myers Squibb Co. and Otsuka American Pharmaceutical Inc., the manufacturer and distributor of Abilify.
The plaintiff, Cheyenne Beth Confer, says her doctor prescribed Abilify “off-label” to treat her depression. She started taking Abilify in May 2009 when she was just 15 years old.
Within six months, she gained 30 pounds and was diagnosed with diabetes — a chronic metabolic condition that requires lifelong medical care. She now must take metformin to control blood-sugar levels.
According to a complaint, defendants failed to warn that children on the average recommended dose of Abilify were 7.7-times more likely to be diagnosed with diabetes. The complaint also accuses defendants of failing to update the Prescribing Information to include data from studies published since 2005.
The Prescribing Information only includes general information about a possible association between anti-psychotic drugs and diabetes. However, it states that there is no evidence linking Abilify with diabetes or changes in fasting blood-sugar (glucose) levels in children with schizophrenia, bipolar disorder, or irritability.
The lawsuit alleges that children could be more sensitive to the metabolic side effects of Abilify, such as rapid weight-gain.
The complaint further alleges that Bristol-Myers Squibb aggressively promoted Abilify “off-label” for unapproved uses in children between 2002 and 2005. In September 2007, Bristol-Myers Squibb agreed to pay $515 million to resolve allegations about improper marketing. The U.S. Department of Justice (DOJ) accused the company of knowingly promoting Abilify for pediatric uses that were not approved by the FDA, in violation of federal law.