Accidental overdose of morphine sulfate oral solutions have resulted in serious adverse events, especially when using the high potency 100 mg/5mL product, according to a warning issued by the U.S. Food & Drug Administration (FDA) yesterday. Roxane Laboratories has notified healthcare professionals of changes in the product label and package meant to reduce the likelihood […]
Accidental overdose of <"https://www.yourlawyer.com/practice_areas/defective_drugs">morphine sulfate oral solutions have resulted in serious adverse events, especially when using the high potency 100 mg/5mL product, according to a warning issued by the U.S. Food & Drug Administration (FDA) yesterday. Roxane Laboratories has notified healthcare professionals of changes in the product label and package meant to reduce the likelihood of these errors.
Morphine oral solution is currently available in 10 mg/5 mL, 20 mg/5 mL, and 100 mg/5 mL (20 mg/mL) concentrations. The 100 mg/5 mL (20 mg/mL) concentration is indicated for relief of moderate to severe acute and chronic pain in opioid-tolerant patients only.
The 100 mg/5 mL (20 mg/mL) dose of morphine oral solution was only approved by the FDA last January. Prior to the recent approval, Roxane marketed a morphine sulfate oral solution with the strength expressed as 20 mg/mL, using a container label and carton labeling that had brown lettering on a white background.
According to a letter set to healthcare professional by Roxane Laboratories, in most of the accidental overdose incidents, morphine sulfate oral solutions ordered in milligrams (mg) were mistakenly interchanged for milliliters (mL) of the product. When this occurred with the high-concentration solution, the result was a 20-fold overdose. Other dosing errors were usually caused by confusion or misunderstanding of the morphine concentration in the oral solution.
The product label and package have now been revised, and new prescribing information added, to help decrease the risk for medication errors, the letter said. Among other things, a medication guide will be enclosed in the carton, which gives step-by-step directions and a pictogram that instructs patients on how to measure an accurate dose using the oral syringe. It also includes information on the associated risks of this medication.
Roxane is advising that healthcare providers familiarize themselves with the instructions in the medication guide and that they should discuss the correct use of the oral syringe with their patients.
