Safety Alert for Human Medical Products: Morphine Sulfate Oral Solution100 mg per 5 mL (20 mg/mL) Medication Use Error. Adverse Events and Death Reported.
What’s the problem?
January 12, 2011 - The FDA notified healthcare professionals of serious adverse events and deaths resulting from accidental overdose of morphine sulfate oral solutions, especially when using the high potency 100 mg/5mL product. In most of these cases, morphine sulfate oral solutions ordered in milligrams (mg) were mistakenly interchanged for milliliters (mL) of the product.
The approval of this product is part of FDA’s unapproved drugs initiative. 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. The newly approved product labeling and packaging feature revisions intended to reduce the risk of medication errors.
Morphine Overdose: Signs & Symptoms
A morphine overdose occurs when an individual ingests more of the drug than the body can handle. Signs of overdose vary by person, and may include:
- cold or clammy skin
- fluid in the lungs
- pinpoint pupils
- difficult or slow breathing
- slowed pulse
- low blood pressure
- extreme fatigue
- blue fingernails and lips
- spasms of the stomach or intestinal tract
Emergency help should be sought immediately if a morphine user experiences any of these symptoms.
FDA Safety Information
For more specific information about this safety alert, please visit the FDA website to view the official press release.
Victim of a morphine overdose? Contact us today.
The Defective Drug & Products Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in morphine sulfite overdose lawsuits. We are handling individual litigation nationwide and currently accepting new Issue cases in all 50 states.