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LETTER |
Clinical Geriatric Psychiatry Center for Aging University of Medicine and Dentistry of New Jersey–School of Osteopathic Medicine Stratford, New Jersey
To the Editor:
I was exceedingly disappointed with the authors' lack of balance regarding the pharmaceutical treatment of patients with bipolar disorder in the June 2004 supplement to the JAOA—The Journal of the American Osteopathic Association. I believe there was a bias toward olanzapine, marketed by Eli Lilly and Company, clearly reflected in the review article by Frederick T. Lewis, DO; Ethan Kass, DO, MBA; and Robert M. Klein, DO, "An Overview of Primary Care Assessment and Management of Bipolar Disorder" (104[Suppl 6]:S2-S8) and in the review article by Frederick T. Lewis, DO, "Bipolar Depression in Primary Care: A Hidden Threat" (104[Suppl 6]:S9-S14). Both articles failed to note that not only olanzapine, but clozapine, risperidone, quetiapine fumarate, and ziprasidone also carry Food and Drug Administration (FDA) indications for the treatment of patients with bipolar disorder.
Atypical antipsychotic use, no matter how efficacious, still carries considerable risk for patients and potential legal risk for prescribing physicians. In his article, Dr Lewis states, "This agent [olanzapine] is generally safer," yet he provides no evidence to support this claim—an important oversight as there is a growing overuse of this drug class, with caution being seemingly thrown to the wind. Although Dr Lewis notes "potential adverse effects that include weight gain, dry mouth, dizziness, drowsiness, edema, and effects on glucose metabolism," he neglects to add that atypical antipsychotic agents also carry risks for Parkinson disease, tardive dyskinesia, and neuroleptic malignant syndrome. Additionally, this drug class has been implicated in increased risks for diabetes (clozapine, olanzapine, quetiapine, risperidone, aripiprazole); hyperlipidemia (clozapine, olanzapine); QT interval prolongation (quetiapine, ziprasidone); and adverse cerebral events (olanzapine, risperidone). These adverse effects, though completely ignored in the supplement articles, must be taken into consideration when prescribing treatment with atypical antipsychotic agents versus anticonvulsant agents, lithium, or even clonazepam.
In the interest of patient safety, it is important to understand and communicate that atypical antipsychotic agents carry potentially serious adverse effects. Although all FDA-approved atypical antipsychotic agents work well in the treatment of patients with bipolar disorder, efficacy must be balanced by potential risk to the patient. It must be noted that atypical antipsychotic agents may not be the best choice for a percentage of patients, especially when their complete medical history and current profile are taken into consideration.
The Office of the Inspector General, US Department of Health and Human Services, conducted a review of the overprescription of atypical antipsychotic agents,1 and multiple lawsuits are ongoing regarding atypical antipsychotic use and hyperglycemia. I would urge the reader to consider all of the facts regarding atypical antipsychotic agents before committing patients to medication with such potentially serious adverse effects when safer alternatives may exist.
References
1. Department of Health and Human Services Centers for Medicare and
Medicaid Services. Psychotropic drug use in skilled nursing facilities
[program memorandum]. October 25, 2002. AB-02-143. Available
at:http://www.cms.hhs.gov/manuals/pm_trans/AB02143.pdf.
Accessed December 21, 2004.
Department of Psychiatry Temple University School of Medicine Philadelphia, Pennsylvania
Your comments concerning atypical antipsychotic agents and bipolar disorder are accurate. I agree with you that fair balance is critical when providing continuing medical education, whether written or verbal.
I appreciate the time you spent sharing your thoughts and hope you will consider contributing to future JAOA—The Journal of the American Osteopathic Association supplements on psychiatric topics.
Footnotes
Editor's note: Dr Baron served as the supplement editor for the
June 2004 supplement to the JAOA—The Journal of the American
Osteopathic Association on the topic of bipolar disorder that is referred
to in the preceding and following letters to the editor.
We note your disappointment in the supplement to the JAOA—The Journal of the American Osteopathic Association on bipolar disorder, though we differ with you on several of the issues you identify. Some of our disagreement is based on professional opinion; some is based on the factual inaccuracies contained in your letter.
First, although the authors received research funding and/or other financial support from Eli Lilly and Company, a thorough review of the authors' full financial disclosures included in the supplement would reveal to you that they received significant financial support from other pharmaceutical companies as well. Further, although Eli Lilly provided the unrestricted educational grant to fund the supplement, that entity was not responsible for the content of the articles. Finally, the articles were peer-reviewed by prominent members of THE JOURNAL's Editorial Advisory Board. If the articles were not balanced, they would not have been accepted for publication.
Second, you support your assertion of bias toward olanzapine by authors of the supplement with the claim that other atypical antipsychotic agents are approved as a treatment for patients with bipolar disorder. Contrary to your claim, clozapine does not have FDA approval as a treatment for patients with bipolar disorder, and, at the time of the preparation and review of the articles included in the supplement, neither did ziprasidone. Risperidone and quetiapine fumarate are FDA-approved only for the treatment of patients with acute mania, not for the treatment of patients with bipolar depression, nor as maintenance treatment for such patients.
You appropriately noted that the most frequent adverse events encountered with atypical antipsychotic agents, including the risk of diabetes, were not included in the articles. Our failure to highlight every potential adverse event is in keeping with the spirit of review articles. Thoughtful physicians recognize that a thorough review of the package insert is necessary before prescribing any medication. Although your assertion that these drugs also place patients at risk for tardive dyskinesia, neuroleptic malignant syndrome, and QT interval prolongation is potentially true, adverse events of this type associated with these agents are extremely rare.
Finally, you allege that safer alternatives than atypical antipsychotic
agents exist for the management of patients with bipolar disorder. We would
like to know to which drugs you are referring (and we suspect that the FDA
would like to know as well, as that agency has seen fit to approve only a
short list of agents for the treatment of patients with bipolar disorder).
Excluding atypical antipsychotic agents, which we feel you have unfairly
vilified, few choices remain, namely, chlorpromazine hydrochloride, lithium,
divalproex sodium, and lamotrigine. We doubt that many physicians would view
these agents as either safer or more efficacious alternatives.
Department of Psychiatry, Department of Family Medicine, Nova Southeastern University College of Osteopathic Medicine Fort Lauderdale, Florida
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