via Alliance for Human Research Protection:
The Alliance for Human Research Protection (AHRP) is a national network of lay people and professionals dedicated to advancing responsible and ethical medical research practices, to minimizing the risks associated with such endeavors and to ensuring that the human rights, dignity and welfare of human subjects are protected
One-in-four American children are being prescribed adult drugs for chronic adult diseases. MEDCO Drug Trend report (2010): children who are covered by health insurance are the drug industry's fastest growing market. In 2009, prescription drug use for U.S. children increased by 5%, while prescription drug spending for children increased 10.8% According to MEDCO, the growth in prescription drug use among American children was nearly four times higher than the rise seen in the overall population. "While H1N1 caused a spike in antiviral use among children last year, the far more alarming trend since the beginning of the decade is the increasing use of medications taken by children on a regular basis and in some cases, for conditions that we don't often associate with youth, such as type 2 diabetes," said Dr. Robert S. Epstein, Medco's chief medical officer and president of the Medco Research Institute." In 2009, the FDA facilitated the expanded use of adult drugs for children when it expanded the labels for pediatric use of drugs for the indications for cholesterol control Welchol® (colesevalm HCl) and Crestor® (rosuvastatin); for hypertensionAtacand® (candesartan cilexetil); for migraines Axert®; for heartburn Protonix® (pantoprazole); and, worst of all, atypical antipsychotic medications Abilify® (aripriprazole), Seroquel® (quetieapine fumarate) and Zyprexa® (olanzapine). At no other time in history have doctors become partners of drug manufacturers prescribing dangerous drugs with serious medical side effects for vast numbers of children. Doctors who prescribe such drugs are disregarding the documented risks of harm for children. Clearly children's vulnerability is being exploited: they are being exposed to adult prescription drugs for chronic adult diseases to meet industry marketing goals. At no other time in history has the US government--i.e., the FDA--lent its seal of approval to the dubious use of such adult drugs for children. Vera Hassner Sharav |
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via Psychopharmacology Bulletin
Atypical Antipsychotic Drugs and Diabetes Mellitus in the US Food and Drug Administration Adverse Event Database: A Systematic Bayesian Signal Detection Analysis
Posted: 02/25/2009; Psychopharmacol Bull. 2009;42(1):1-21. © 2009 MedWorks Media Global
Results: All six atypicals had an EB05 ≥ 2 for at least one DRAE. The most common event was diabetes mellitus (2,784 cases). Adjusted reporting ratios (CIs) for diabetes mellitus were: olanzapine 9.6 (9.2–10.0; 1306 cases); risperidone 3.8 (3.5–4.1; 447 cases); quetiapine 3.5 (3.2–3.9; 283 cases); clozapine 3.1 (2.9–3.3; 464 cases); ziprasidone 2.4 (2.0–2.9; 74 cases); aripiprazole 2.4 (1.9–2.9; 71 cases); haloperidol 2.0 (1.7–2.3; 139 cases). Logistic regression odds ratios agreed with adjusted reporting ratios.
Conclusions: In the AERS database, lower associations with DRAEs were seen for haloperidol, aripiprazole and ziprasidone, and higher associations were seen for olanzapine, risperidone, clozapine and quetiapine. Our findings support differential risk of diabetes across atypical antipsychotics, reinforcing the need for metabolic monitoring of patients taking antipsychotics.
generic name brand
resperidone is Risperdal
olanzapine is Zyprexa
clozapine is Clozaril
quetiapine is Seroquel
haloperidol is Haldol
aripiprazole is Abilify
ziprasidone is Geodon
via Journal of Clinical Psychiatry
Prediabetes in Patients Treated With Antipsychotic Drugs
Peter Manu, MD; Christoph Correll, MD; Ruud van Winkel, MD, PhD; Martien Wampers, PhD; and Marc De Hert, MD, PhD
J Clin Psychiatry
10.4088/JCP.10m06822
Copyright 2011 Physicians Postgraduate Press, Inc.
Background: In 2010, the American Diabetes Association (ADA) proposed that individuals with fasting glucose level of 100–125 mg/dL (5.6–6.9 mmol/L) or glucose level of 140–199 mg/dL (7.8–11.0 mmol/L) 2 hours after a 75-g oral glucose tolerance test or hemoglobin A1c 5.7%–6.4% be classified as prediabetic, indicating increased risk for the emergence of diabetes mellitus. At the same time, the ADA formulated guidelines for the use of metformin for the treatment of prediabetes.
Objective: To determine the prevalence of prediabetes in a cohort of psychiatrically ill adults receiving antipsychotics and to compare the clinical and metabolic features of prediabetic patients with those of patients with normal glucose tolerance and those with diabetes mellitus.
Method: The 2010 ADA criteria were applied to a large, consecutive, single-site European cohort of 783 adult psychiatric inpatients (mean age: 37.6 years) without a history of diabetes who were receiving antipsychotics. All patients in this cross-sectional study underwent measurement of body mass index (BMI), waist circumference, oral glucose tolerance test, and fasting insulin and lipids from November 2003 through July 2007.
Results: 413 patients (52.8%) had normal glucose tolerance, 290 (37.0%) had prediabetes, and 80 (10.2%) had diabetes mellitus. The fasting glucose and/or hemoglobin A1c criteria were met by 89.7% of prediabetic patients. A statistically significant intergroup gradient from normal glucose tolerance to prediabetes and from prediabetes to diabetes mellitus was observed for waist circumference, triglycerides, fasting insulin levels, and frequency of metabolic syndrome (P = .02 to P <.0001). Only 19/290 prediabetic patients (6.6%) met the 2010 ADA criteria for treatment with metformin.
Conclusions: Prediabetes is highly prevalent in adults treated with antipsychotic drugs and correlates with markers of increased intraabdominal adiposity, enhanced lipolysis, and insulin resistance. Criteria for using metformin to prevent the emergence of diabetes mellitus may need to be revised for this population. (emphasis mine)
J Clin Psychiatry
© Copyright 2011 Physicians Postgraduate Press, Inc.
Submitted: December 27, 2010; accepted April 18, 2011.
Online ahead of print: December 27, 2011 (doi:10.4088/JCP.10m06822).
Corresponding author: Peter Manu, MD, Zucker Hillside Hospital, Medical Services, 75-59 263rd St, Glen Oaks, NY 11004 (pmanu@lij.edu).
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