Transcript 2003ProductRecall_Lockwood_Palladone

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/PostmarketDrugSafetyI
nformationforPatientsandProviders/ucm129288.htm
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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
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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.
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References
•
FDA:
•
– http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationf
orPatientsandProviders/ucm129288.htm
Defective Drugs
•
– http://www.adrugrecall.com/palladone/palladone.html
WebMD
•
– http://www.webmd.com/pain-management/news/20050714/palladonepain-drug-pulled-off-market
New York Times
•
– http://query.nytimes.com/gst/fullpage.html?res=9D02EED6103DF937A2
5754C0A9639C8B63
Medicine Net
•
– http://www.medicinenet.com/hydromorphone_extended_releaseoral/article.htm
Drug Information Online
– http://www.drugs.com/mtm/palladone.html
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