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Palladone – Product RecallOn July 13, 2005, the drug manufacturer of Palladone, Purdue Pharma, agreed to the FDA’s request to pull the drug completely from the US market because of possible deaths that may occur when combined with the use of alcohol.Palladone, approved in September 2004 for patients with chronic moderate to severe pain, is a formulation of the controlled narcotic, hydromorphone. This narcotic or Opioid is popular among those suffering from arthritis. While this issue was not apparent during Palladone’s clinical trials, Purdue Pharma later discovered that alcohol could cause the active ingredient, hydromorphone, to be released too quickly into the bloodstream. In fact, the entire dose of the drug could be released all at once causing deadly implications. In general, Opioid drugs, such as Dilaudid, Vicodin, and Lorcet, should not be combined with alcohol, but Palladone has an increased risk due to the advanced drug delivery mechanism. The FDA has taken the position that the lethal risk of Palladone cannot be mitigated by revised warning labels. Purdue is cooperating with the FDA’s request to revise the drug’s formula and hopes to remarket it at a later date. To quote Steven Galson, acting director for the FDA’s Drug Center, “We are concerned that as more people take this drug, safety problems will arise since having one alcoholic drink could have fatal implications.” If you or a loved one suffered an overdose on Palladone due to the drinking of alcohol concurrent with the use of the medication, you may have a cause for legal action. Likewise, if a loved one passed away from an apparent overdose of Palladone, logic dictates that new questions about the possible role of alcohol in that death could provide the basis for a wrongful death claim or other potential legal action. In the News Don't Mix Slow-Release Painkillers with Alcohol: Health Canada. (Aug-03-05) [CBC NEWS]Side Effects Lead FDA to Bar Sale of Painkiller. (Jul-14-05) [NEW YORK TIMES] LEGAL NOTICE AND
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