Palladone Pain Drug Pulled Off the Market

July 14, 2005 - Purdue Pharma has voluntarily taken its pain-relieving Palladone capsules off the market, the drugmaker says in a news release.

The company took the action on July 13 following an FDA request to withdraw Palladone because of safety concerns.

The FDA approved Palladone in September 2004. The drug was launched by Purdue Pharma this February.

Palladone was approved for the management of persistent, moderate-to-severe pain in patients requiring continuous, around-the-clock pain relief with a high-potency opioid for an extended period of time, states a Purdue Pharma news release.

Patients taking Palladone should consult their doctors about alternative treatments, states an FDA news release.FDA's Statement

An FDA news release states that "serious and potentially fatal adverse reactions can occur when Palladone ( hydromorphone hydrochloride) extended release capsules are taken together with alcohol."

Hydromorphone is a narcotic analgesic; it relieves pain and is also a cough suppressant.

According to the FDA news release, "Palladone is a once-a-day pain management drug containing a very potent narcotic. New data gathered from a company-sponsored study testing the potential effects of alcohol use shows that when Palladone is taken with alcohol the extended release mechanism is harmed which can lead to dose-dumping."

Dose-dumping, the FDA says, is the rapid release of the drug's active ingredient into the bloodstream. The agency's news release says dose-dumping, even with a low dose of Palladone (12 milligrams), could lead to "serious, or even fatal, adverse events in some patients."

The FDA warns that the risk increases for higher doses of Palladone.

Symptoms of a hydromorphone overdose include slow breathing, seizures, dizziness, weakness, loss of consciousness, confusion, coma, tiredness, cold and clammy hands, and small pupils.

The FDA says Purdue Pharma has greed to suspend the sale of Palladone in the U.S. until the company discusses safety issues with the agency.

"All powerful pain management drugs have serious risks if used incorrectly, but the current formulation [extended release capsules] of Palladone presents an unacceptably high level of patient risk," says Steven Galson, MD, MPH, FDA acting director of the Center for Drug Evaluation and Research, in the news release.

"Although we have not received reports of serious problems, this product has so far been used in a relatively small number of patients. We are concerned that as more patients take this drug, safety problems will arise since even having one alcoholic drink could have fatal implications," continues Galson.

According to the FDA, Palladone's current label already has a standard opioid warning about the use of alcohol and Palladone. But the FDA release notes that the agency doesn't believe that "potentially fatal, adverse events can be effectively managed by label warnings alone. ..."

Purdue Pharma's Statement

Purdue Pharma's news release states that the company has "implemented a plan to reformulate Palladone capsules to reduce the risk of an alcohol interaction with the product."