FDA Warns of Morphine Sulfate Oral Solution Overdose
100 mg per 5 mL product ordered in mg may be mistakenly interchanged for mL of the product
TUESDAY, Jan. 11 (HealthDay News) -- The U.S. Food and Drug Administration and Roxane Laboratories have notified health care professionals of serious adverse events and deaths associated with accidental overdose of morphine sulfate oral solutions, especially with the high potency (100 mg per 5 mL) product. In most cases, solutions ordered in milligrams (mg) were mistakenly interchanged for milliliters (mL) of the product.
Morphine sulfate oral solution is indicated for the treatment of moderate to severe acute and chronic pain in patients who are tolerant to opioid treatment. Roxane Laboratories previously marketed the 100 mg per 5 mL product with the strength indicated as 20 mg/mL; however, newly approved product labeling features revisions aimed at reducing the risk of medication errors.
The changes made to the labeling and product packaging include a warning stating "only for use in patients who are opioid tolerant," the strength clearly indicated as 100 mg per 5 mL followed by a less prominently displayed concentration of 20 mg/mL, differentiated coloring, and a reminder for pharmacists to dispense the product using the medication guide. The 30 mL and 120 mL bottles of morphine sulfate 100 mg per 5 mL (20 mg/mL) also contain a calibrated oral syringe in their packaging to provide accurate dosing.
According to the FDA, "health care providers should discuss the correct use of the oral syringe with their patients."