American Institute of Pharmaceutical Sciences (AIPS)

Dose Errors Prompt Morphine Label Update

WASHINGTON -- The FDA and the maker of a high-potency oral morphine sulfate solution warned healthcare professionals of potential accidental overdosing issues and have updated labeling to minimize patient risk.

Serious adverse events and deaths have resulted from accidental overdose of morphine sulfate oral solutions, especially when using the high-potency 100 mg/5mL product, according to the notice from FDA and Roxane Laboratories, the manufacturer. In most of these cases, morphine sulfate oral solutions ordered in milligrams (mg) were mistakenly interchanged for milliliters (mL) of the product, the statement said.

Before this labeling change, Roxane had marketed a morphine sulfate oral solution with the strength expressed as 20 mg/mL, using a container label and carton labeling that had brown lettering on a white background. The newly approved product labeling and packaging changes are intended to reduce the risk of medication errors.

The updated labeling of Roxane's Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) includes:A box warning that specifies the product is to be used in opioid-tolerant patients only, since administration to patients naive to opioids may result in fatal respiratory depression.

  • A dose strength of "100 mg per 5 mL," which deemphasizes the concentration of 20 mg/mL and minimizes confusion over which ratio represents the solution's strength

  • A bright yellow background to distinguish the higher-strength morphine solution from other morphine solution strengths marketed by Roxane, which use white backgrounds

  • A white-lettered-on-red-background name, strength, and concentration to further distinguish the product

  • A reminder for pharmacists to include a medication guide with prescriptions of the drug.

The updated product also includes a calibrated oral syringe for precise dosing.

A warning letter issued by Roxane Laboratories also included prescribing instructions for healthcare professionals, which emphasized the inclusion of concentration of the oral solution, lack of abbreviation of morphine sulfate, and intended dose of the drug -- in milligrams and in milliliters -- with written-out directions.

The FDA approved the high-concentration morphine sulfate in January 2010 for opioid tolerant patients with moderate-to-severe acute and chronic pain, and for patients in end-of-life care.


January 11 2011
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