Results of forty years Yellow Card reporting for commonly used perioperative analgesic drugs

Pharmacoepidemiol Drug Saf. 2007 Jun;16(6):687-94. doi: 10.1002/pds.1403.

Abstract

Background: A variety of analgesics are used perioperatively and associated adverse drug reactions (ADRs) may complicate anaesthesia and recovery.

Methods: We aimed to measure the demographics of reported suspected ADRs to alfentanil, fentanyl, ketorolac, morphine, nalbuphine, papaveretum, pethidine and remifentanil. We report a retrospective analysis of Yellow Card reports of suspected ADRs from 1965-2004 as classified in the Adverse Drug Reaction On-line Tracking database (ADROIT) of the Medicines and Healthcare products Regulatory Agency (MHRA).

Results: In total, 1312 reactions were retrieved. A single drug was reported in 908, 39 were fatal and 219 categorised as 'allergic'. Allergic phenomenon varied from 2/33 (6%) for remifentanil to 11/53 (21%) for alfentanil. 'Cardiovascular' reactions were reported frequently with remifentanil (18/33, 55%) and alfentanil (19/53, 36%) and these generated a signal for possible hazards from proportional reporting ratios (PRRs). The opioid fentanyl was associated with similar hazard signals for muscular and psychiatric ADRs.

Conclusions: Perioperative vigilance may reduce morbidity and mortality from preventable ADRs to analgesic drugs. Denominator and diagnostic data are essential for prospective studies.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Adverse Drug Reaction Reporting Systems*
  • Aged
  • Aged, 80 and over
  • Analgesics / adverse effects*
  • Drug Hypersensitivity / epidemiology
  • Female
  • Fentanyl / adverse effects
  • Humans
  • Male
  • Middle Aged
  • Respiration / drug effects
  • Retrospective Studies
  • Time Factors

Substances

  • Analgesics
  • Fentanyl