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Re: Olanzapine and side effects

Posted by SalArmy4me on August 26, 2001, at 23:41:38

In reply to Olanzapine and side effects, posted by SaM on October 22, 1998, at 2:43:33

Muniz, Edmundo MD, PhD. Finding drug link to reaction. American Journal of Health-System Pharmacy. 56(15):1559, August 1, 1999:

"With respect to olanzapine and NMS, our analysis of the postmarketing data indicates that the overall clinical picture is reassuring. Two years after the drug was approved by FDA and after more than 2.1 million patient exposures, the reported rate of olanzapine-related NMS was less than 0.01%.

Many of the reports of NMS had at least one of the following problems:

- Failed to meet well-accepted diagnostic criteria, either from lack of necessary inclusion criteria (e.g., fever) or the presence of other exclusionary diagnoses (e.g., alcohol abuse or withdrawal, thyrotoxicosis, electrolyte imbalance),

- Involved preexisting risk factors (e.g., concomitant neuroleptic therapy, concomitant lithium therapy, history of NMS, organic brain disease, dehydration, withdrawal of an anticholinergic agent, elevated ambient body temperature), and

- Lacked sufficient information for a health care professional to make an adequate clinical assessment.

Information on NMS appears prominently in the warnings section of the olanzapine package insert and includes four paragraphs describing the clinical signs and treatment of NMS. The postmarketing data have not rendered this warning insufficient.

We thank Ms. Hammond for underscoring the importance of comprehensive ADR reporting in order to monitor adverse events and evaluate their significance. Lilly's comprehensive postmarketing "pharmacovigilance" program depends on these reports, as does our continuing commitment to maximizing the safe use of the company's products."

Edmundo Muniz, M.D., Ph.D., Director

Worldwide Pharmacovigilance and Epidemiology; Eli Lilly and Company; Lilly Corporate Center; Indianapolis, IN 46285


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