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Palladone Withdrawal

The Palladone withdrawal from the market was announced by the drug's maker, Purdue Pharmaceuticals, on July 13, 2005 as requested by the FDA. The FDA requested the Palladone withdrawal less than one year after they approved this potent opioid for use in the United States. The Palladone withdrawal was prompted by Purdue-sponsored clinical studies, which found a fatal risk in combining Palladone with alcohol.

While drugs like Palladone have been available in Germany, the United Kingdom, and Canada, Palladone was the first extended release prescription narcotic of its kind to be approved for use in the United States. Palladone was initially approved exclusively for the management of persistent moderate to severe pain in patients for whom shorter-acting opioids had not been successful.

There are many reasons proposed for why a drug like Palladone had not been approved sooner. Palladone belongs to a class of drugs that has the highest potential for abuse and the highest risk of fatal respiratory depression. Palladone was designed to provide extended pain relief to patients who have already developed a tolerance to opioids. If a non-tolerant individual consumes Palladone, they face the risk of suffering life-threatening respiratory depression.

Palladone is also a dangerous drug because of its potential for abuse. Drug abusers without a tolerance for opioids may suffer a serious overdose of this drug. Palladone has a high potential for abuse because it produces euphoric heroin-like effects in higher quantities. To achieve this effect, drug abusers will either consume too many pills or alter the pill's form to receive a higher dose. When Palladone is broken, chewed, crushed, or dissolved, consumption can lead to a fatal overdose.

These serious risks of Palladone drug abuse where already known before the Palladone withdrawal. The drug was approved despite the risks associated with abuse because the pain management afforded by Palladone was greatly beneficial to patients. When fatal adverse reactions were discovered in patients for whom the drug was prescribed and properly administered, the Palladone withdrawal was issued. The FDA stated that "Palladone presents an unacceptably high level of risk."

The Palladone withdrawal was ultimately prompted by the finding that consumption of even one alcoholic drink while taking Palladone could prompt a fatal drug reaction. Researchers have found that alcohol acts like a "dose dumper" when combined with Palladone. Dose dumping is the rapid release of Palladone's active ingredient into the bloodstream. This can lead to a fatal overdose of Palladone.

Purdue estimates that 11,500 patients took their product before the Palladone withdrawal. Patients who were using Palladone are encouraged to speak with the physicians as soon as possible to discuss a safe and effective alternative treatment. If you are concerned about the risks that prompted the Palladone withdrawal, please contact us to speak with a qualified and experienced attorney who can determine your legal rights and options.

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