On July 13, the Food and Drug Administration (FDA) announced that it had asked Purdue Pharma L.P. to remove Palladone, its extended-release narcotic painkiller, from the market. Purdue Pharma complied with the FDA’s request and agreed to suspend sales and marketing of Palladone. This drug is used for pain management in patients with moderate to severe pain who need continuous relief.

The FDA’s request was made in response to data from a Purdue Pharma-sponsored study that indicated a problem with Palladone’s extended release mechanism when the drug is paired with alcohol. When a patient combines Palladone with alcohol, the extended-release mechanism is harmed, which can lead to dose dumping-the accelerated release of an extended-release drug into the blood stream. The active ingredient in Palladone is a formulation of hydromorphone, which can cause serious or fatal side effects when combined with alcohol and dumped too quickly into the blood stream. Possible side effects include slowed breathing, coma, or death.

The FDA instructs patients who are currently taking Palladone to contact their prescribing physician to discuss other treatment options, including immediate release hydromorphone. For patients that are advised by their physician to continue taking Palladone, it is incredibly important that they do not drink any alcohol while on this medication. Patients should also avoid any over-the-counter medications that contain alcohol while on Palladone. The FDA asks patients to flush any leftover Palladone capsules down the toilet to ensure that the drug is disposed of safely.

For more information, visit http://www.fda.gov/cder/drug/infopage/palladone/default.htm.