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drug_recall palladoneAfter the FDA acquired information regarding serious and potentially deadly Palladone side effects, the agency asked the makers of the drug, Purdue Pharma L.P., to withdraw it from the market on June 13, 2005. Palladone was FDA approved in September 2004 for the management of persistent, moderate-to-severe pain in patients requiring continuous pain relief, but a company-sponsored study showed if the drug is taken with alcohol it could harm the extended release mechanism.
Palladone is a once-a-day pain management drug that contains a very potent narcotic, so data indicating alcohol could result in deadly Palladone side effects was extremely concerning. According to the FDA, all powerful pain management drugs are associated to very serious risks when used incorrectly, but Palladone side effects presented a considerably greater potential effect.
Even one alcoholic drink, according to Dr. Steven Galson, FDA Acting Director of the Center for Drug Evaluation and Research, could have fatal Palladone side effects. When the extended release mechanism on the drug is injured dose-dumping can occur, allowing the rapid release of the active ingredient into the bloodstream. Because the drug is a morphine-based narcotic that is so potent it only needs to be taken once every 24 hours, dose-dumping can lead to extremely serious and fatal Palladone side effects.
According to Purdue Pharma, the Palladone side effects risks involving alcohol interactions were “ appropriately addressed” in its Risk Management Program, but the company still agreed to immediately discontinue sales and marketing of the drug in response to the agency’s request. Due to the potentially fatal Palladone side effects, the FDA did not believe the drug’s label warnings and a risks management plan alone could allow the drug to be effectively managed. Palladone labeling included the standard opioid warning against the use of the drug and alcohol.
Pending further discussions with the FDA about Palladone side effects, the company said it would work closely in launching the drug on a limited basis with a rigorous risk management program. Neither the FDA nor Purdue Pharma had received Palladone side effects reports at the time of the drug withdrawal announcement, but the agency said only a relatively small number of patients had used the drug.
Palladone was not even on the market for six-months when the FDA learned of the company’s study testing the potential effects of alcohol use and the Palladone side effects it revealed. According to Purdue’s news release, approximately 11,500 patients had been prescribed the drug. Galson said the agency was concerned Palladone side effects would arise if more patients took the drug.
The FDA advised patients taking Palladone to consult with their physician.
Contact a Palladone Lawyer today to find out more on the dangerous effects of Palladone.
The U.S. Food and Drug Administration has asked Purdue Pharma to stop the sale and marketing of its potent new pain drug, Palladone, after just five months on the market. The decision was made after the agency acquired new information regarding the in...