Revised Warnings for Avinza
November 10, 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.
The following new and/or additional text has been added to the Package Insert for AVINZA.
Black Box Warning, Warnings, and Dosage and Administration sections:
Patients must not consume alcoholic beverages while on AVINZA therapy. Additionally, patients must not use prescription or non-prescription medications containing alcohol while on AVINZA therapy. Consumption of alcohol while taking AVINZA may result in the rapid release and absorption of a potentially fatal dose of morphine.
Precautions, Information for Patients section:
Patients should be informed that they must not consume alcoholic beverages while on AVINZA therapy. Additionally, patients should be informed that they must not use prescription or non-prescription medications containing alcohol while on AVINZA therapy. Consumption of alcohol while taking AVINZA may result in the rapid release and absorption of a potentially fatal dose of morphine.
Clinical Pharmacology and Warnings sections:
In vitro studies performed by the FDA demonstrated that when AVINZA 30 mg was mixed with 900 mL of buffer solutions containing ethanol (20% and 40%), the dose of morphine that was released was alcohol concentration-dependent, leading to a more rapid release of morphine. While the relevance of in vitro lab tests regarding AVINZA to the clinical setting remains to be determined, this acceleration of release may correlate with in vivo rapid release of the total morphine dose, which could result in the absorption of a potentially fatal dose of morphine.
Patients taking Cylert or generic pemoline should NOT discontinue taking their medication before speaking with their physician.
As always, pharmacies and members can contact the RxAmerica Customer Service Desk at 1-800-770-8014 if they have any questions about this new drug information.
