FDA ASKS PURDUE PHARMA TO WITHDRAWL PALLADONE:
The FDA has asked Purdue Pharma L.P. of Stamford, Conn., to withdraw the pain drug Palladone (hydromorphone) from the market after the agency acquired new information indicating that potentially fatal adverse reactions can occur when Palladone extended-release capsules are taken with alcohol.
Palladone is a once-a-day pain management drug containing a very potent narcotic. New data from a company-sponsored study testing the potential effects of alcohol use show that when Palladone is taken with alcohol, the extended-release mechanism is harmed, which can lead to dose-dumping. Dose-dumping is a term that describes the rapid release of the active ingredient from an extended-release product into the bloodstream.
The consequences of dose-dumping at the lowest marketed dose--12 milligrams--of Palladone could lead to serious, or even fatal, adverse events in some patients. The risk is even greater for the higher strengths of the product. As a result of this potential serious safety risk, the FDA has asked Purdue Pharma, and they have agreed, to suspend all sales and marketing of Palladone in the United States, pending further discussions with the agency.
"All powerful pain management drugs have serious risks if used incorrectly, but the current formulation of Palladone presents an unacceptably high level of patient risk," says Steven Galson, M.D., Director of the FDA's Center for Drug Evaluation and Research. "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."
The current labeling for Palladone, approved in September 2004, already includes the standard opioid warning against the use of alcohol and Palladone. But the FDA does not believe that the risk of serious, and potentially fatal, adverse events can be effectively managed by label warnings alone and by a risk management plan.
People who currently take Palladone should consult with their physicians for alternative treatments. See www.fda.gov/cder/drug/infopage/palladone/default.htm for more information.