Palladone Pain Drug Pulled Off the Market
FDA Concerned About Drug's Potentially Fatal Interaction With Alcohol
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
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
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
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."