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Palladone and Alcohol

The U.S. Food and Drug Administration asked Purdue Pharma L.P. to withdraw Palladone from the market on July 13, 2005 because of safety reasons. Palladone is an extended release, once-a-day pain management drug containing a very potent narcotic. The FDA said it determined serious and potentially fatal reactions can occur when Palladone and alcohol are mixed, resulting in its decision to ask the company to immediately halt sales and marketing of the drug.

Palladone was FDA approved in September 2004 and was not even on the market for six months before the agency ordered its removal. Based on data gathered from a company-sponsored study testing the potential effects of alcohol, results showed concurrent use of Palladone and alcohol harmed the extended release mechanism. Because the drug contains such a potent narcotic, should the Palladone and alcohol mix affect the extended release, dose-dumping can occur.

Dose-dumping is the term meaning that the active ingredient in the drug is released into the blood stream. Since Palladone's extended release allows the active ingredient to last 24-hours, dose-dumping can have a very dangerous effect on a patient. Consequences of mixing Palladone and alcohol can be deadly, and even when taken at the lowest marketed dose (12 mg.) risks are still very present in some patients. As higher strengths of the product are taken, the risks of mixing Palladone and alcohol become even greater.

Purdue Pharma agreed to withdraw Palladone, but the company issued a statement saying the company launched the drug with "clear and strong warnings" about the Palladone and alcohol interaction, and that the warnings regarding it were "appropriately addressed" in its Risk Management Program. Current labeling for Palladone already included the standard opioid warning against the use of Palladone and alcohol, but the FDA believed that considering the serious, potentially deadly risks, the label warning and a risk management plan were not adequate enough to effectively manage the drug.

According to Dr. Steven Galson, FDA Acting Director of the Center for Drug Evaluation and Research, "Palladone presents an unacceptably high level of patient risk" greater than risks already associated to powerful pain drugs. Both the FDA and Purdue Pharma said they have not received any adverse event reports involving Palladone and alcohol, but the agency said the drug has been used in a relatively small number of patients. Purdue Pharma said approximately 11,500 patients have been prescribed Palladone, and the FDA wanted to reduce any potential Palladone and alcohol interaction risks by asking that the drug be recalled before more patients took it.

According to Galson, even one alcoholic drink could have fatal outcomes. Any patients currently taking Palladone should consult with their physicians to discuss alternative treatment plans.

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