Watchdogs worried about antipsychotic use in children now have more ammo. A new study links the drugs with Type 2 diabetes. Published in the journal JAMA Psychiatry, the study found a threefold increase in diabetes risk for kids who take antipsychotic drugs compared with those taking other psychotropic drugs.
The study results add to data linking antipsychotic drugs to weight gain, insulin resistance and diabetes in adults. Drugmakers Johnson & Johnson ($JNJ), Eli Lilly ($LLY) and AstraZeneca ($AZN) have faced thousands of lawsuits from patients claiming their antipsychotic treatments--Risperdal, Zyprexa and Seroquel, respectively--caused them to develop diabetes. The companies have also faced allegations that they specifically promoted the drugs for off-label use in children.
What's worrisome about the latest study--conducted by researchers from the Mayo Clinic, Columbia University, the FDA and Vanderbilt University--is that use of antipsychotic drugs in children has grown rapidly in recent years. The drugs are often prescribed off-label for attention deficit disorder (ADD) and other behavioral problems, with an especially high prescription rate among kids covered by Medicaid or in foster care.
The researchers zeroed in on these uses of Risperdal, Zyprexa, Seroquel and the Bristol-Myers Squibb ($BMY) pill Abilify. More than 28,800 people aged 6 to 24 years who used the antipsychotics were compared with some 14,400 patients given other drugs. The increased risk of diabetes cropped up within the first year of use, the researchers said.
"We need to be more cautious when starting an antipsychotic for a child or youth and think about other alternatives, perhaps trying those other alternatives first," study author Wayne Ray told The Wall Street Journal.
Antipsychotic drugmakers have been called on the carpet for promoting their products for off-label use. Lilly, Bristol-Myers and AstraZeneca each have settled off-label marketing claims with the U.S. government, with atypical antipsychotics at the center of each. Lilly allegedly promoted Zyprexa for use in children before it was approved by the FDA for that use. AstraZeneca allegedly promoted Seroquel for ADHD, among other off-label uses. Bristol-Myers stood accused of pushing Abilify specifically to child psychiatrists and other pediatric specialists. Meanwhile, J&J is negotiating a marketing settlement with the Justice Department involving Risperdal, among other drugs.
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