Roxane Laboratories and the US Food and Drug Administration (FDA) have notified healthcare professionals of serious adverse events and deaths resulting from accidental overdose of morphine sulfate oral solutions. In addition, the manufacturer has updated the product’s label to help prevent dosing errors.
Most dosing errors occurred with the high-potency 100 mg/5 mL product, when the oral solutions prescribed in milligrams (mg) were mistakenly interchanged for milliliters (mL).
Some key changes include:
- The warning statement, “Only for Use in Patients who are Opioid Tolerant,” is displayed in a box to highlight the potential for 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).
- A bright yellow background is used on multiple sides of this product to differentiate the oral solution from other morphine solutions marketed by Roxane, which have a white background.
- The drug name, strength, and concentration are displayed in white lettering on a red background as an additional means of differentiation.
Read the FDA press release: