FDA Warns of Morphine Overdoses Due To Medication Errors

A morphine solution manufactured by Roxane Laboratories, Inc., which was only approved one year ago, has already been tied to a number of morphine overdoses and deaths, leading federal regulators to issue a warning to consumers and causing the drug maker to create a new label to avoid dosage confusion. 

The FDA issued a morphine overdose safety alert on Monday, warning that serious adverse events and deaths have been linked to overdoses of morphine sulfate oral solutions from Roxane Laboratories. Most of the cases appear to have been due to someone misreading the label of the 100 mg/5mL doses, confusing the milligrams (mg) for milliliters (mL).

When milligrams are mistaken for milliliters, the dosage a patient receives could be 20 times stronger than what was intended, likely resulting in a drug overdose. In some overdose cases a 5 mg dose was administered as a 5 mL dose, which is equal to 100 mg. Roxane has agreed to change its labeling as a result of the confusion.

The new labels will have a warning that reads “ONLY FOR USE IN PATIENTS WHO ARE OPIOID TOLERANT” and the 100 mg per 5 mL dosage indication will be followed by (20 mg/mL). This is to distinguish it from the company’s 20 mg/5 mL product. The more powerful dosage will also have white lettering on a red background to differentiate it from weaker doses.

Roxane’s morphine sulfate oral solution was approved by the FDA in January 2010 for the treatment of moderate to severe acute and chronic pain. It was part of the FDA’s unapproved drugs initiative. The initiative was designed to address a number of painkillers that were being released in strengths that had not been approved by the FDA. A number of generic morphine, oxycodone, hydromorphone and roxanol manufacturers were ordered to stop making extremely potent doses of painkillers until they got approval from the FDA.

In recent years, prescription drug poisoning has surpassed automobile accidents as the leading cause of unintentional injury death among people between the ages of 35 and 54. According to research released last year from the West Virginia University School of Medicine, there was a 65% increase in prescription drug overdoses between 1999 and 2005, commonly involving overdoses of morphone, OxyContin and fentanyl.