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FDA warns of accidental overdose with morphine sulfate oral solution
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The FDA and Roxane Laboratories, manufacturer of morphine sulfate oral solution, have notified health care professionals of serious adverse events and deaths associated with accidental overdose of the drug, especially in the 100 mg/5 mL dose. According to an agency press release, most overdoses were a result of the drug being interchanged for milliliters instead of milligrams during the ordering process.
The drug was recently approved by the FDA as part of its unapproved drugs initiative. Prior to approval, the drug strength was labeled as 20 mg/mL with brown and white packaging. Since then, Roxane Laboratories has updated their product label and packaging in an effort to reduce the risk for medication errors.
The following changes have been made by the manufacturer and are included in a letter to health care professionals:
- A warning stating “ONLY FOR USE IN PATIENTS WHO ARE OPIOID TOLERANT” is displayed in a box to highlight that the morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is indicated for use in opioid-tolerant patients only. The 100 mg per 5 mL concentration of morphine sulfate may cause fatal respiratory depression when administered to patients not previously exposed to opioids.
- The strength is presented as 100 mg per 5 mL followed by a less prominently displayed concentration of (20 mg/mL). The intent of this designation is to help differentiate this product from the 20 mg/5 mL morphine sulfate product.
- A bright yellow background is used on multiple sides of this product to differentiate the morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) from other morphine sulfate oral solutions marketed by Roxane with a white background.
- The drug name, strength and concentration are displayed in white lettering on a red background as an additional means of differentiating this product from other concentrations of morphine sulfate oral solutions.
- A reminder is presented to the pharmacist to dispense the product to each patient with the enclosed Medication Guide.
- Both the 30 mL and 120 mL bottles of morphine sulfate 100 mg per 5 mL (20 mg/mL) oral solution are packaged with a calibrated oral syringe to provide accurate dose measurements. Healthcare providers should read the instructions in the Medication Guide that describe the correct use of the oral syringe in order to help prevent medication errors from occurring.
- Healthcare providers should discuss the correct use of the oral syringe with their patients.
To read the full MedWatch safety alert, letter and prescribing information, visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239559.htm.