FDA Warns of Overdose Risk With Morphine Sulfate Oral Solution

Manufacturer to Update Labeling, Prescribing Information

January 12, 2011 05:30 pm News Staff

Roxane Laboratories and the FDA are alerting physicians to serious adverse events and deaths resulting from accidental overdose of morphine sulfate oral solutions. In response to these reports, the Columbus, Ohio-based manufacturer is updating its product labeling to help prevent such errors.

The FDA approved Roxane's Morphine Sulfate Oral Solution 100 mg per 5 mL for relief of moderate to severe acute and chronic pain in opioid-tolerant patients last year. The manufacturer also produces two similar products:

  • Morphine Sulfate Oral Solution 20 mg/5 mL and
  • Morphine Sulfate Oral Solution 10 mg/5 mL.

The FDA said in a Jan. 10 safety alert(www.fda.gov) that in most of the reported overdose cases, medication ordered in milligrams was mistakenly given in milliliters.

Roxane said in a December letter to health care professionals(www.fda.gov) that such mistakes could lead to a patient receiving a 20-fold overdose.

According to the letter, physicians writing prescriptions for morphine sulfate oral solution should take the following steps to ensure patients receive the proper dose:

  • do not abbreviate the name of the drug;
  • clearly state the concentration of morphine sulfate; and
  • state the intended dose of morphine in milligrams (mg), with the corresponding volume in milliliters (mL) written in the directions.

The medication comes with a boxed warning that addresses the risk of medication errors; the same information is included in the indications and usage, dosage and administration, and warnings and precautions sections of the prescribing information.

Roxane also said it is making the following label changes to its 100 mg/5 mL product:

  • A new warning indicates the product is "only for use in patients who are opioid-tolerant." The higher-dose concentration of morphine sulfate may cause fatal respiratory depression when administered to patients not previously exposed to opioids.
  • The strength now is presented as "100 mg per 5 mL," with "20 mg/mL" in parentheses below it to differentiate the product from the manufacturer's 20 mg/5 mL product.
  • A bright yellow background is used on multiple sides of the product label to differentiate it from Roxane's other morphine sulfate oral solution labels, which have white backgrounds.

Finally, a medication guide will be included in each product carton. Roxane urged health care professionals to read the instructions that describe proper use of the calibrated oral syringe that is packaged with both the 30-mL and 120-mL bottles of morphine sulfate 100 mg/5 mL and to discuss those instructions with their patients.


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