What is a secret is why the FDA would give pharma the Christmas present of approving Seroquel and Zyprexa for children and hence, Medicaid reimbursement even as its own Division of Pharmacovigilance (DPV) reported a "a direct association between adverse metabolic effects of treatment with atypical antipsychotics" and children! A hypothesis the DPV report says is "provocative" and requires "robust" followup.
FDA approved the drugs--Seroquel Immediate Release tablets to treat schizophrenia in adolescents ages 13-17 and bipolar mania in children and adolescents ages 10-17; Zyprexa to treat schizophrenia and manic or mixed episodes associated with bipolar I disorder in adolescents aged 13-17-- even as studies continue to link the drugs to Diabetes mellitus, hyperglycemia, diabetic ketoacidosis, hyperlipidemia, galactorrhea and hyperprolactinemia in children.
The FDA's own Adverse Event Reporting System database "contains thousands of domestic reports describing extrapyramidal symptoms and metabolic effects reported in association with these agents," says the DPV report in addition to "a number of lawsuits against olanzapine [Zyprexa] and quetiapine [Seroquel] involving metabolic effects."
Fifty-one medical journal articles since 1999 link Zyprexa alone with diabetic ketoacidosis, an acute metabolic condition which can rapidly escalate to cerebral edema and coma. Four articles recount sudden death in patients who had no personal or family history of diabetes mellitus and normal levels of the drug in their system.
In fact June FDA Psychopharmacological Advisory Committee hearings about approving Seroquel and Zyprexa for children itemized those exact side effects. AstraZeneca physician Liza O'Dowd did a valiant job of assuring committee members that weight, glucose and prolactin elevation side effects of Seroquel could be "controlled and monitored" in patients and that they "didn't lead to discontinuation of the study." (Hopefully not when the study lasted weeks).
But Christopher B. Granger, MD, Director of Duke University Medical Center's Cardiac Care confessed to "real discomfort" approving drugs which "generat[e] metabolic syndrome in adolescents in a very short period of time" for "indefinite use" on the basis of three or six week trials. "Hopefully we're not exposing someone for decades," he said. Colleague, Edward L.C. Pritchett, MD with Duke's Cardiology and Clinical Pharmacology agreed.
So the FDA's gift to pharma of new uses and insurance reimbursement for atypical antipsychotics comes as a surprise. Call it Pharma's Secret Santa.
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