Avinza is a morphine sulfate extended-release capsule used to treat moderate to severe pain that requires 24-hour opioid therapy for an extended period of time.
Laboratory studies by the Food and Drug Administration (FDA), however, have shown that the presence of alcohol in sufficient concentrations will cause a rapid release of the morphine.
The studies by the FDA tested a 30-mg dose in 900-mL buffer solutions containing 20% and 40% ethanol. Although the clinical relevance of the data has not been established, the accelerated release of morphine observed in vitro may correlate with in vivo release and absorption of a potentially fatal dose of morphine.
As a result of these findings, the FDA and Ligand Pharmaceuticals Inc. have warned healthcare professionals of the potential risk of morphine overdose associated with alcohol use in patients taking Avinza. The following alert issued by the FDA can be found at http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Avinza:
Avinza (morphine sulfate extended-release capsules)
Audience: Pain specialists, other healthcare professionals and consumers
[Posted 11/03/2005] Ligand Pharmaceuticals Inc. and FDA notified healthcare professionals of revisions to BOXED WARNING, WARNINGS, PRECAUTIONS, CLINICAL PHARMACOLOGY, and DOSAGE AND ADMINISTRATION sections of the prescribing information to highlight and strengthen the warning that patients should not consume alcohol while taking Avinza. Additionally, patients must not use prescription or non-prescription medications containing alcohol while on Avinza therapy.
Links to the corresponding warning letter and label change can be found following the above alert. Patients receiving morphine therapy should be warned not to consume alcoholic beverages or use prescription or over-the-counter medications containing alcohol.
Additional information regarding use of morphine extended-release capsules may be obtained by contacting Avinza Information Service at 1-888-8-AVINZA (1-888-828-4692). Adverse events related to the use of Avinza should be reported to the same number.
Adverse events may also be reported to the FDA’s MedWatch program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.