Palladone Side Effects Injury Lawsuits. On July 13, 2005, the Food and Drug Administration ordered Purdue Pharma to remove Palladone (Generic: Hydromorphone hydrochloride from the U.S. market. The FDA cited potentially fatal overdose reactions when the powerful painkiller drug is taken together with alcohol. Palladone is a once-a-day version of the old painkiller Hydromorphone, which uses slow-release delivery to slowly administer this potent narcotic over a 24-hour period. The FDA said the slow-release function can fail, causing the entire dose to enter the bloodstream at once and potentially causing a fatal overdose.
serious risks if used incorrectly
Dr. Steven Galson, FDA Acting Director of the Center for Drug Evaluation and Research said, 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. Even one drink could have fatal implications. For this reason the FDA acted quickly, recalling the drug only 5 months after Palladone sales began. The FDA action came after new data gathered from a Purdue Pharma-sponsored study testing the potential effects of alcohol use showed 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 blood stream. The consequences of dose dumping at the lowest marketed dose 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. Purdue Pharma received FDA approval for Palladone in September 2004. Purdue Pharma also manufactures Oxycontin, which has been linked to addiction, overdosing and death.