Potential confusion in morphine sulfate oral solutions dosage prompts label alteration

FDA and Roxane Laboratories are warning of serious adverse events and deaths as a result of a mistake in dosage of morphine sulfate oral solutions.

In most of the cases, morphine sulfate oral solutions ordered in milligrams were mistakenly interchanged for milliliters. The result may be that a prescribed 5-mg dose is mistakenly administered as 5 mL, representing a 20-fold overdose. The risk of overdose is especially high when using the high-potency, 100 mg/5 mL product for relief of moderate to severe pain in opiod-tolerant patients, according to FDA.

Errors also may stem from a lack of understanding of the concentration of morphine in the oral solution, according to Columbus, Ohio-based Roxane Laboratories.

Roxane Laboratories has changed the packaging and labeling of the product. New packaging includes the warning, “Only For Use in Patients Who are Opioid Tolerant.” Another change is dose strength, which is now presented as 100 mg/5 mL, followed by 20 mg/mL less prominently displayed. The intent is to differentiate the product from the 20 mg/5 mL morphine sulfate product.

Before the change, the dose strength was expressed as 20 mg/mL, potentially leading to confusion.