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FDA and Morphine Manufacturer Alter Drug Labeling to Prevent Overdoses

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FDA and Morphine Manufacturer Alter Drug Labeling to Prevent Overdoses

In an effort to minimize patient risk, the FDA and manufacturer Roxanne Laboratories, which produces an oral morphine medication, have updated the drug's labeling and warned healthcare professionals of the risks involved with the medication. A number of deaths have been tied to the drug, which was approved only one year ago.

Most deaths occurred when patients misread the labeling, mistaking milligrams for milliliters and taking up to 20 times the recommended dosage. The altered labeling now bears a warning that reads, "Only for use in patients who are opioid tolerant" in all caps, with the 100 milligram per five milliliter dosage indication followed by (20 mg/mL), distinguishing it from the 20 milligram per five milliliter product.

The label will also have different coloring. A yellow background will distinguish a higher strength morphine from other morphines the manufacturer markets. Healthcare providers will also be reminded to include a medication guide and calibrated oral syringe with the medication.

Last year, the medication was approved for patients in end-of-life care and for those with moderate-to-severe acute and chronic pain.