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FDA BLACK BOX WARNING AVINZA capsules are a modified-release formulation of morphine sulfate indicated for once daily administration for the relief of moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time. AVINZA CAPSULES ARE TO BE SWALLOWED WHOLE OR THE CONTENTS OF THE CAPSULES SPRINKLED ON APPLESAUCE. THE CAPSULE BEADS ARE NOT TO BE CHEWED, CRUSHED, OR DISSOLVED DUE TO THE RISK OF RAPID RELEASE AND ABSORPTION OF A POTENTIALLY... |
FDA BLACK BOX WARNING AVINZA capsules are a modified-release formulation of morphine sulfate indicated for once daily administration for the relief of moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time. AVINZA CAPSULES ARE TO BE SWALLOWED WHOLE OR THE CONTENTS OF THE CAPSULES SPRINKLED ON APPLESAUCE. THE CAPSULE BEADS ARE NOT TO BE CHEWED, CRUSHED, OR DISSOLVED DUE TO THE RISK OF RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF MORPHINE. 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. |
On Nov. 3, 2005, the Food and Drug Administration (FDA) and Ligand Pharmaceuticals Inc. of Gainesville, Ga., the manufacturer of morphine extended release capsules (AVINZA), announced revisions to the drug’s black box warning. The warning addresses the possibility of receiving a fatal dose of morphine when the drug is chewed, crushed, dissolved, or used with alcohol.
A black box warning is the strongest type of alert that the FDA can request from a drug manufacturer. Black box warnings may be requested after a drug has caused serious injury or death to patients who have used it. Drugs bearing such a warning usually meet this standard.
Avinza was approved by the FDA in March 2002. It is used for the once-daily treatment of moderate to severe pain in patients who require continuous, around-the-clock opioid therapy for an extended period of time.
On July 13, 2005, the FDA asked the maker of a long-acting form of another potent narcotic painkiller called hydromorphone (PALLADONE) to remove the drug from the market because of a potentially fatal interaction with alcohol. The FDA has also asked the manufacturer of the long-acting morphine product Kadian to add a new warning about a possible interaction with alcohol to the drug’s professional product label (see Worst Pills, Best Pills News September 2005).
The problem with these drugs is not the morphine, which is an extremely valuable, very old pain reliever, but the modified release capsules sold by Ligand Pharmaceuticals and other companies. As with Palladone, anything that can damage Avinza’s modified release system such as chewing, crushing, dissolving, or taking the drug with alcohol can cause a rapid release of morphine rather than a gradual release. This can lead to what is called dose-dumping, or the rapid release of the active ingredient (morphine) into the blood stream. In this case, dose-dumping can result in a potentially fatal overdose of morphine.
What You Can Do
If you are now taking Avinza or Kadian, you should ask your doctor whether another painkiller such as immediate-release morphine might be more appropriate. If you decide to continue taking Avinza or Kadian, you should be sure never to consume alcohol or chew, crush, or dissolve the capsules.
