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.
References
- FDA’s drug approval down in 2010. www.drugs.com/news/fda-s-approval-down-2010-28669.html. Published December 31, 2010. Accessed January 24, 2011.
- FDA approves Amgen’s XGEVA (denosumab) for the prevention of skeletal-related events in patients with bone metastases from solid tumors. www.amgen.com/media/media_pr_detail.jsp?year=2010&releaseID=1498709. Published November 18, 2010. Accessed January 24, 2011.
- U.S. Food and Drug Administration. Approved Risk evaluation and mitigation strategies. www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm. Published January 14, 2011. Accessed January 24, 2011.
- Perry L, Kaufman MB. Pipeline 2011. Drug Topics. 2011;155:30-40.
- Frieden J. FDA okays another fentanyl product. www.medpagetoday.com/PainManagement/PainManagement/24242. Published January 7, 2011. Accessed January 10, 2011.
- Dr. Reddy’s announces the launch of Pantoprazole Sodium delayed-released tablets. www.drreddys.com/media/popups/jan20_2011.html. Published January 20, 2011. Accessed January 24, 2011.
- FDA grants supplemental approval for ACTEMRA (tocilizumab). www.gene.com/gene/news/press-releases/display.do?method=detail&id=13147. Published January 5, 2011. Accessed January 8, 2011.
- Dane L. FDA extends review of GlaxoSmithKline, Human Genome Sciences’ Benlysta. www.firstwordplus.com/Fws.do?articleid=90722752BC6247119BB608B38FB5B7B0&logRowId=393011. Published December 3, 2010. Accessed January 24, 2011.
- Supplemental BLA submitted for Remicade for pediatric ulcerative colitis. www.empr.com/supplemental-bla-submitted-for-remicade-for-pediatric-ulcerative-colitis/article/193430/?DCMP=EMC-MPR_WeeklyNewsbrief. Published December 29, 2010. Accessed January 3, 2011.
- King Pharmaceuticals and Pain Therapeutics announce resubmission of new drug application for REMOXY. www.kingpharm.com/Investors/News_Details.cfm?news_item_id=568. Published December 27, 2010. Accessed January 24, 2011.
- King Pharmaceuticals and Acura Pharmaceuticals announce submission of New Drug Application for ACUROX tablets. www.kingpharm.com/Investors/News_Details.cfm?news_item_id=567. Published December 29, 2010. Accessed January 24, 2010
- Endo Pharmaceuticals provides regulatory update on new formulation of OPANA ER designed to be crush-resistant. http://phx.corporate-ir.net/phoenix.zhtml?c=231492&p=irol-newsArticle_print&ID=1514262. Published January 7, 2011. Accessed January 10, 2011.
- Endo Pharmaceuticals Opana ER. www.endo.com/Opana. aspx. Accessed January 24, 2011
- Ardea Biosciences reports positive results for RDEA594, its lead product candidate for gout, in combination with allopurinol or febuxostat. www.medicalnewstoday.com/articles/175402.php. Published January 8, 2011. Accessed January 24, 2011.
- Phase 2b study of RDEA594 for the treatment of gout. www.empr.com/phase-2b-study-of-rdea594-for-the-treatment-of-gout/article/193868/. Published January 7, 2011. Accessed January 10, 2011.
- Dennis M. Novartis starts mid-stage trial of biosimilar version of Roche’s Rituxan. www.firstwordplus.com/Fws.do?articleid =438774BDB43448269895FCE494E97D70. Published January 10, 2011. Accessed January 11, 2011.
- Dennis M. Merck & Co. in deal with Parexel to develop biosimilars. www.firstwordplus.com/Fws.do?articleid=411CA68F1931475B92F0A475730DE0CA&logRowId=396586. Published January 12, 2011. Accessed January 24, 2011.
- Dennis M. Bayer, Johnson & Johnson seek EU, US approval of Xarelto for stroke prevention. www.firstwordplus.com/Fws.do?articleid=93CCEB75BBF64F2BB3993F73EAF006F4&logRowId=395681. Published January 5, 2011. Accessed January 24, 2011.
- Garrett AD. Pradaxa primer: A guide to treatment with dabigatran etexilate. Drug Topics. 2011;155:42-43.
- Fritsch B. FDA’s Safe Use Initiative. Pharmacy Today. 2010 ;9:61.
- NABP recommends boards of pharmacy prohibit use of acetaminophen abbreviation. www.nabp.net/news/nabp-recommends-boards-of-pharmacy-prohibit-use-of-acetaminophen-abbreviation. Published July 15, 2010. Accessed January 4, 2011.
- Signals for acetaminophen, dronedarone, and botulinum toxin. ISMP Medication Safety Alert QuarterWatch Report (2010 Quarter 1). November 4, 2010;15:1-3.
- U.S. Food and Drug Administration. Acetaminophen Information. www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm165107.htm. Last updated January 27, 2011. Accessed January 27, 2011.
- Morphine sulfate oral solution 100 mg per 5 mL (20mg/mL): Medication use error reports of accidental overdose. www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239559.htm. Published January 10, 2011. Accessed January 11, 2011.
- Nelson R. Fatal medication errors seen with high-dose morphine oral solution. www.medscape.com/viewarticle/735564. Accessed January 10, 2011.