Roxane Laboratories is reissuing its high-potency morphine with a redesigned label bearing bold colors, a boxed warning and other precautions following deaths and other serious adverse events due to misreading of the dosage - six months after the director of FDA's Division of Medication Error Prevention and Analysis said publicly that the company's standardized use of label colors was causing confusion.
The redesigned label uses color to make sure prescribers and patients understand the dosage for Roxane's 100 mg/5 mL morphine sulfate oral solution and can distinguish it at a glance from lower-strength Roxane morphine products.
Where the old label used brown lettering on a white background, the new one uses a bright yellow background on multiple sides of the product, so that it is distinct from other Roxane morphine products that still use a white background. Also, the new high-potency label gives the drug name, strength and concentration in white lettering on a red background.
The problem and the solution were both foreshadowed at a June 24 workshop FDA sponsored on medication errors At that meeting, Marissa Craddock, a regulatory affairs/labeling specialist for Roxane, said that the company uses brown on most of its drug labels, but distinguishes the highest strengths with red.
"A lot of the types of errors that we see, especially with the Roxane product line, are really attributed to that brown ... that's used across all the products," Carol Holquist director of FDA's Division of Medication Error Prevention and Analysis, said. "It's really great that you differentiate strength, but it's really hard to tell what product's in there."
