Roxane Laboratories has made labeling and product-packaging changes to its morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) due to accidental overdoses that resulted in adverse events and deaths. The product is indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients.
Roxane had marketed a morphine sulfate oral solution in a strength expressed as 20 mg/mL. That container label and carton labeling carried brown lettering on a white background. Now, a bright-yellow background is being used on multiple sides of the morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) to differentiate it from other such solutions with a white background marketed by the company. White lettering on a red background is used to present the drug name, strength, and concentration. The strength is presented as 100 mg per 5 mL, followed by a less prominently displayed concentration of “(20 mg/mL).”
The new label also carries a boxed warning stating: only for use in patients who are opioid tolerant. Another boxed warning refers to the risk of accidental overdose and deaths caused by the confusion between different concentrations and between “mg” and “mL.” These and other product labeling and packaging changes have been made to help reduce the risk of medication errors.
According to Roxane and the FDA, which notified oncology, pharmacy, and pain management practitioners to the usage errors in conjunction with the manufacturer, in most cases the solutions ordered in milligrams were mistakenly interchanged for milliliters. The Roxane letter, which includes a complete description of the changes to the carton, container, and packaging of the 100 mg per 5 mL (20 mg/mL) morphine sulfate oral solution, reminds providers to read the instructions in the medication guide and to discuss the correct use of the oral syringe with patients. ONA