WITHDRAWN OR REMOVED DRUG PRODUCTS

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WITHDRAWN OR REMOVED DRUG PRODUCTS

• CAPT George R. Scott, M.S., R.Ph.
• Center for Drug Evaluation and Research
• Office of Compliance
• Division of Prescription Drug Compliance and
  Surveillance

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Withdrawn or RemovedDrug Products

• Must not compound drugs that appear on a list
  published in the Federal Register that were
• withdrawn OR
• removed from the market BECAUSE
• the drug or component of drug was found unsafe or
  not effective

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Proposed Rule Published in FR

• October 8, 1998
• 63 FR 54082
• Primary focus was safety

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Withdrawn or Removed Drug Products Final Rule

• March 8, 1999
• 64 FR 10944
• 59 drug products

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Withdrawn or RemovedProposed Rule

• Aminopyrine and Astemizole
• Published January 4, 2000
• 65 FR 256

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Aminopyrine

• Analgesic and antipyretic
• Caused agranulocytosis
• Declared a new drug in 1964
• 42 FR 53954, (October 4, 1977)

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Astemizole

• Astemizole tablets marketed as Hismanal
• Life-threatening heart arrhythmias
• Removed from market by manufacturer on June 18,
  1999
• 64 FR 45973 (August 23, 1999)

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Cisapride

• Tablets and suspension marketed as Propulsid
• 341 reports of heart rhythm abnormalities 80
  reports of death
• Manufacturer to discontinue marketing on July 14,
  2000
• Available only through an investigational limited
  access program

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Grepafloxacin

• Tablets marketed as Raxar
• Fluoroquinolone antibiotic
• Removed from market by firm on October 27, 1999
• Firm considered therapeutic benefit outweighed by
  potential safety risk

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Troglitazone

• Tablets marketed as Rezulin
• Severe liver toxicity linked to reports of
  confirmed liver failures and deaths
• Removed from market by manufacturer on March 21,
  2000
• Posed unacceptable risk compared to similar,
  alternative diabetes drugs

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Conclusion

• Advisory Committee members invited to review and
  comment on list
• Specifically seeking comments on
• Additional products to be added
• Whether proposed products should go on list

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