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Drug UPDATES

Michele B. Kaufman, PharmD, BCGP  |  Issue: March 2011  |  March 18, 2011

Morphine sulfate oral solution 100 mg/5 mL (20 mg/mL) has undergone a label revision due to inadvertent overdoses when ordered in milligrams (mg), which was later misread as milliliters (mL).24,25 This has led to 20-fold overdoses when the high-concentration product was used instead of lower-concentration products (e.g., 10 mg/5 mL or 20 mg/5 mL). Morphine sulfate oral solution is approved by the FDA to relieve moderate to severe acute and chronic pain in opioid-tolerant patients only. The product label has been revised with a bright yellow background (compared with a white background for the lower concentrations) as well as the product name being displayed in white letters on a red background. Other label revisions help to differentiate it from similar products, to help decrease medication error risks.

Michele Kaufman is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

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References

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Filed under:Drug Updates Tagged with:ApprovalsDrugsFDASafety

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