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U.S. Department of Health and Human Services


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Misconceptions about ADR Reporting

Figueiras A et al. Med Care 1999;37(8):809–814
Eland I A et al. Br J Clin Pharmacol 1999;48(4):623–627
Chyka PA et al. Drug Saf 2000;23(1):87–93


  • All serious ADRs are documented by the time a drug is marketed
  • It is difficult to determine if a drug is responsible
  • ADRs should only be reported if absolutely certain
  • One reported case can’t make a difference

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