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In a study published last week in the medical journal Pediatrics, U.S. researchers indicate that giving a child under the age of 18 atypical antipsychotic drugs appears to nearly quadruple their risk of developing diabetes.
The researchers looked at data on more than 74,000 children between the ages of five and 18, finding that after just an average of 4.5 months on antidepressants, 3.23 out of every 1,000 children given the drugs were diagnosed with diabetes. That compares to 0.76 children per 1,000 diagnosed with diabetes who are not on antipsychotics.
Scientists say that it is known that antipsychotics can cause weight gain, which can lead to diabetes. However, those involved in the study say that there appears to be more going on with these drugs than simple weight gain.
The study comes about two months after an FDA advisory panel urged the agency to closely watch the side effects of atypical antipsychotics for weight gain. The panel of experts called on the FDA to better clarify weight gain and diabetes warnings on the drugs.
The new generation of antipsychotics are being more frequently prescribed to children for a wide variety of psychological disorders, such as psychoses, autism, ADHD or bipolar disorder, even though many of them are not approved for those uses. While most of the antipsychotics were prescribed to children between 7 and 12 years of age, the medications have been prescribed to toddlers as young as two years-old.
Seroquel (quetiapine fumarate) is an atypical-antipsychotic that is a top selling drug for AstraZeneca, generating nearly $5 billion a year in sales. Originally approved by the FDA in 1997 for the treatment of schizophrenia, it has also been frequently prescribed off-label for uses that were not approved as safe and effective at the time, such as anxiety, obsessive dementia, compulsive disorders and autism. AstraZeneca reached a $520 million settlement with the Department of Justice (DOJ) over off-labeling charges last year.
AstraZeneca has also settled more than 28,000 Seroquel lawsuits filed by former users of the medication who alleged that the drug maker failed to adequately warn about the risk of diabetes from Seroquel side effects.