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Purdue withdraws Palladone

July 15, 2005 1:28 AM UTC

Purdue (Stamford, Conn.) withdrew pain drug Palladone hydromorphone extended-release capsules from the market because of the risk of overdose if combined with alcohol. FDA said it requested the withdrawal after new data from a Purdue study showed that alcohol harms the extended release mechanism, which can lead to the rapid release of the active ingredient into the blood stream. The agency said that even at the lowest marketed dose, this "could lead to serious, or even fatal, adverse events in some patients." FDA added that it has not received any reports of serious problems. Purdue said the drug has been prescribed to 11,500 patients. The product's label warns against the use of alcohol, but FDA said it "does not believe the risk of serious, and potentially fatal, adverse effects can be managed by label warnings alone and a risk management plan." ...