palladone drug recall what: –palladone – potent pain drug produced by purdue pharma when: –fda...

Palladone Drug Recall • What: – Palladone – potent pain drug produced by Purdue Pharma • When: – FDA initiated recall in June 2005; drug approved in September 2004, first manufactured in February 2005 • Why: – The drug was pulled over concerns of serious to fatal consequences if taken with alcohol. The drug's extended release mechanism is compromised if taken with alcohol and can lead to dose dumping of the powerful active ingredient hydromorphone. • FDA Consumer Link: – http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandPro viders/ucm129288.htm Nov. 4, 2010 1 ETM 591 Andrew Lockwood

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Palladone Drug Recall• What:

– Palladone – potent pain drug produced by Purdue Pharma

• When: – FDA initiated recall in June 2005; drug approved in September 2004, first

manufactured in February 2005

• Why: – The drug was pulled over concerns of serious to fatal consequences if

taken with alcohol. The drug's extended release mechanism is compromised if taken with alcohol and can lead to dose dumping of the powerful active ingredient hydromorphone.

• FDA Consumer Link:

– http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm129288.htm

Nov. 4, 2010 1ETM 591 Andrew Lockwood

Page 2: Palladone Drug Recall What: –Palladone – potent pain drug produced by Purdue Pharma When: –FDA initiated recall in June 2005; drug approved in September

Management Issues• Recognition of Problem:

– In 2005, a study involving 24 men was conducted that involved subjects taking the 12-mg Palladone extended release capsule with 240 mL of 40% alcohol. The result was an average peak hydromorphone concentration 6x higher than that taken with water. Due to this powerful release (active used as an alternative to morphine and heroin), it was pulled in the U.S. market.

• Speed of Response to Problem:– Recall initiated after the study was published in June 2005.– No fatalities / serious injuries have been reported– Interestingly, drug was manufactured and has NOT been recalled

in Canada and continues to be used in the original form since 2004.

– Drug still available in the UK under the name Palladone SR as well as many other European countries

Nov. 4, 2010 2ETM 591 Andrew Lockwood

Page 3: Palladone Drug Recall What: –Palladone – potent pain drug produced by Purdue Pharma When: –FDA initiated recall in June 2005; drug approved in September

Impact of Recall• Legal Consequences:

– Purdue Pharma has been proactive in retracting marketing for the Palladone pain drug ever since the FDA asked them to withdraw it from the market.

– No incidents have been reported to date• Sales:

– No exact 'lost sales' numbers were reported; however, at the time of the recall, 11,500 patients were prescribed to the drug.

• Reputation:– Palladone wasn't the only drug that has damaged Purdue Pharma's

reputation. In 2007, the pain drug OxyContin was also found to have major side effects.

– Purdue Pharma manufactures strong painkillers, but their reputation was tarnished a bit in the news due to the release of the report about the potentially fatal effects with alcohol.

Nov. 4, 2010 3ETM 591 Andrew Lockwood