Roxane Laboratories and the Federal Drug Administration have notified healthcare professionals of serious adverse events and deaths resulting from accidental overdose of morphine sulfate oral solutions, according to an ASA news release.
In most overdose cases, morphine sulfate oral solutions ordered in milligrams were mistakenly swapped for milliliters of the product. Prior to the recent approval of the high potency 100 mg/5mL product, Roxane marketed a morphine sulfate moral solution with the strength expressed as 20 mg/mL.
The newly approved product labeling and packaging feature revisions intended to reduce the risk of medication errors, according to the report.
Read the ASA release on Roxane Laboratories.
Read more on the FDA:
-FDA Approves Opioid Analgesic for Breakthrough Cancer Pain
-7 GI/Endoscopy Devices Receive FDA Approval
In most overdose cases, morphine sulfate oral solutions ordered in milligrams were mistakenly swapped for milliliters of the product. Prior to the recent approval of the high potency 100 mg/5mL product, Roxane marketed a morphine sulfate moral solution with the strength expressed as 20 mg/mL.
The newly approved product labeling and packaging feature revisions intended to reduce the risk of medication errors, according to the report.
Read the ASA release on Roxane Laboratories.
Read more on the FDA:
-FDA Approves Opioid Analgesic for Breakthrough Cancer Pain
-7 GI/Endoscopy Devices Receive FDA Approval