Safety Alerts & Recalls

What does this mean?

This alert is a reminder to all patients who take oral morphine sulfate solutions to work closely with your doctor and pharmacist to make sure you are familiar with your morphine prescription and understand the directions provided by your doctor. If you or someone you care for receives a prescription for morphine sulfate oral solution, please review the directions for your prescription and make sure you understand how to measure the dose before you leave your pharmacy:

1) The directions on your prescription for morphine sulfate oral solution should be written with the dose in milligrams (mg) with the corresponding volume in milliliters (mL).

2) Be sure you have accurate dosing dispenser, such as an oral syringe labeled with measurements that match the prescription directions. Review how to measure the correct volume for the prescribed dose with your pharmacist or other healthcare provider.

3) You should read the Medication Guide provided with your prescription and you should discuss any concerns with your pharmacist or other healthcare provider.

If you have other questions or concerns about oral morphine sulfate solution, please follow up with your healthcare provider. Please seek medical attention as soon as possible if you think you are experiencing serious side effects from morphine, especially if your breathing slows down, you have shallow breathing (little chest movement with breathing), you feel faint, dizzy, confused, or you have any other unusual symptoms.

Reports of Accidental Overdose With Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL)

Roxane Laboratories and the Food and Drug Administration (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. When this occurs with a high concentration oral solution, such as Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL), the result is a 20-fold overdose. Other errors were a result of a lack of understanding of the concentration of morphine in the oral solution.

Roxane currently distributes three different concentrations of morphine sulfate oral solutions. To ensure that patients receive the proper dose of morphine sulfate oral solution, healthcare providers are advised to include the following information in their prescription for morphine sulfate oral solution: (1) The concentration of morphine sulfate oral solution (write out morphine sulfate and do not use abbreviations) to be dispensed.

(2) The intended dose of morphine in milligrams (mg) with the corresponding volume in milliliters (mL) written out in the directions.

Pharmacists are also reminded to dispense a Medication Guide with each prescription of a morphine sulfate oral solution product.

For more information, please visit: more information here

Source: FDA
Publication Date: 2011-01-11
Last Updated: 2011-01-12

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