Roxane Laboratories and the FDA have notified healthcare professionals of serious adverse events and deaths resulting from accidental overdose of morphine sulfate oral solutions, especially when using the high potency 100mg per 5mL product. In most of these cases, morphine sulfate oral solutions ordered in milligrams (mg) were mistakenly interchanged for milliliters (mL) of the product. The FDA has approved new product labeling and packaging feature revisions intended to reduce the risk of medication errors. The prescribing information has also been updated to include a Boxed Warning for risk of medication errors, where confusion between different concentrations and between “mg” and “mL” has resulted in accidental overdose and deaths.
New product labeling and packaging changes include:
- A boxed warning stating “ONLY FOR USE IN PATIENTS WHO ARE OPIOID TOLERANT”
- The strength is presented as 100mg per 5mL followed by a less prominently displayed concentration of (20mg/mL) to help differentiate this product from the 20mg/5mL morphine sulfate product.
- A bright yellow background to differentiate morphine sulfate oral solution 100mg per 5mL (20mg/mL) from other dosage strengths marketed by Roxane with a white background.
- The drug name, strength and concentration are displayed in white lettering on a red background
- A calibrated oral syringe to provide accurate dose measurements
- A reminder is presented to the pharmacist to dispense the product to each patient with the enclosed Medication Guide.
Morphine sulfate oral solution 100mg per 5mL (20mg/mL) is indicated for relief of moderate to severe acute and chronic pain in opioid-tolerant patients.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239559.htm.