Magazine article FDA Consumer

FDA Asks Purdue Pharma to Withdraw Palladone

Magazine article FDA Consumer

FDA Asks Purdue Pharma to Withdraw Palladone

Article excerpt

The FDA has asked Purdue Pharma L.P. of Stamford, Conn., to withdraw the pain drug Palladone (hydromorphone) from the market after the agency acquired new information indicating that potentially fatal adverse reactions can occur when Palladone extended-release capsules are taken with alcohol.

Palladone is a once-a-day pain management drug containing a very potent narcotic. New data from a company-sponsored study testing the potential effects of alcohol use show 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 bloodstream.

The consequences of dose-dumping at the lowest marketed dose--12 milligrams--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. As a result of this potential serious safety risk, the FDA has asked Purdue Pharma, and they have agreed, to suspend all sales and marketing of Palladone in the United States, pending further discussions with the agency. …

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