FDA Reports on Fatal Morphine Oral Solution Medication Errors

According to a recent report from the U.S. Food and Drug Administration (FDA) that our Washington D.C. medication error lawyers have been following, a morphine solution that was approved by the administration last year, has been linked to a series of morphine overdoses and deaths due to medication error—leading federal regulators to issue a warning and initiate a label change to prevent personal injury or death.

The FDA’s recent notification to the health care industry and consumers reported on the overdoses and deaths that have occurred as a result of morphine sulfate oral solution medication errors, most of which are linked to the high potency (100 mg per 5mL) product, where solutions ordered in milligrams (mg) were erroneously mistaken for milliliters (mL) of the drug, causing fatal overdoses.

When milligrams (mg) are misread and confused for milliliters (mL), the patient dosage could reportedly be as high as 20 times stronger than the dosage intended for the patient, which could result in a drug overdose. Other medication mistakes were reportedly caused by confusion in medication dosage, and understanding the morphine concentration in the oral solution.

As our medication mistake attorneys in Baltimore, Maryland have reported in a related blog, according to the Institute of Medicine’s (IOM), 1.5 million people are injured by preventable medication errors every year, with 98,000 annual deaths from medical errors—7,000 of which are due to medication mistakes.

The morphine sulfate oral solution is manufactured by Roxane Laboratories, Inc., and is used to tread moderate to severe chronic and acute pain with patients who are opioid-tolerant. In a blog from this week, our attorneys discussed the danger associated with an incorrect administration of a powerful prescription pain medication and the prevalence of fatal medication overdoses with patients who are opioid-intolerant and are erroneously prescribed these medications.

According to the FDA announcement, the Morphine solution product labeling and packaging changes include a warning that states that only opioid-tolerant patients should use the drug, with the morphine strength clearly indicated as 100 mg per 5mL followed by the displayed concentration of 20 mg/mL differentiated by coloring—to remind pharmacists to dispense the morphine product using the medication guide, and to prevent possible medication errors that can lead to wrongful death.

The FDA claims that the 30 mL and 120 mL bottles of 100mg per 5mL (20 mg/mL) also contain an oral syringe that is calibrated to provide accurate dosing and prevent medication error with consumers. A medication guide will also be included in the carton, giving each clear directions on how to measure an accurate dose using the oral syringe.

Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL): Medication Use Error – Reports of Accidental Overdose, FDA MedWatch, January 10, 2011
Fatal Medication Errors Seen With High-Dose Morphine Oral Solution, Medscape Today, January 10, 2011
FDA Warns of Morphine Sulfate Oral Solution Overdose, MD News, January 11, 2011

Related Web Resources:

Medication Errors Harm 1.5M U.S. Residents Annually, Institute of Medicine Report Says, Medical News Today, July 25, 2006

Institute of Medicine (IOM)

U.S. Food and Drug Administration: Medication Error Reports

Institute for Safe Medication Practices, (ISMP)

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