Palladone Drug Recall

1
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/PostmarketDrug
  SafetyInformationforPatientsandProviders/ucm129288
  .htm

2
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

3
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.

4
References

• FDA
• http//www.fda.gov/Drugs/DrugSafety/PostmarketDrug
  SafetyInformationforPatientsandProviders/ucm129288
  .htm
• Defective Drugs
• http//www.adrugrecall.com/palladone/palladone.htm
  l
• WebMD
• http//www.webmd.com/pain-management/news/20050714
  /palladone-pain-drug-pulled-off-market
• New York Times
• http//query.nytimes.com/gst/fullpage.html?res9D0
  2EED6103DF937A25754C0A9639C8B63
• Medicine Net
• http//www.medicinenet.com/hydromorphone_extended_
  release-oral/article.htm
• Drug Information Online
• http//www.drugs.com/mtm/palladone.html