Adverse drug reactions database

Lindquist M, Stahl M, Bate A, et al. A retrospective evaluation of data mining approach to aid finding new adverse drug reaction signals in the WHO international database. Drug Safety 2000 23 533 2. 

Article 102 includes a provision that requires Member States to share information collected through their pharmacovigilance system with other Member States and the EMEA. The central database EudraVigilance has been developed to allow Member States and the EMEA to share information on adverse drug reactions once all Member States have populated it. 

Diplopia may be an early sign of generalized drug-induced muscle dysfunction. Altogether, 71 cases of diplopia, possibly related to various HMG-CoA inhibitors, have been collected from adverse drug reactions-report-ing databases. The information was mostly too scanty to judge a causal relation, but improvement occurred in 33 on withdrawal, and two patients had positive rechallenge data (52). 

Since the individual drug trials are too small, too short, and otherwise inadequate to the task, it remains the ultimate responsibility of the drug company to go through the complete, combined database in search of patterns of adverse drug reactions. Even if drug companies were properly motivated, there is no foolproof way to oversee the entire group of several thousand patients. 

The relation between neuroleptic drug therapy and myocarditis and cardiomyopathy has been examined using the international database on adverse drug reactions run by the World Health Organization (152). Myocarditis and cardiomyopathy were reported rarely as suspected adverse drug reactions, and accounted for under 0.1% (n = 2121) of almost 2.5 million reports. The association of clozapine with those adverse reactions was statistically significant (231 reports out of 24 730), as was the association with other antipsychotics (89 of 60 775). 

Review of a Canadian adverse drug reactions database showed several cases of previously unreported benzodiazepine-induced adverse effects, including hallucinations and encephalopathy (97), although whether benzodiazepines alone were responsible is difficult to confirm. Visual hallucinations have also been reported in association with zolpidem (98). 

Patten SB, Love EJ. Neuropsychiatric adverse drug reactions passive reports to Health and Welfare Canada s adverse drug reaction database (1965-present). Int J Psychiatry Med 1994 24(l) 45-62. 

Zhao SZ, Reynolds MW, Lejkowith J, Whelton A, Arellano FM. A comparison of renal-related adverse drug reactions between rofecoxib and celecoxib, based on the World Health Organization/Uppsala Monitoring Centre safety database. Chn Ther 2001 23(9) 1478-91. 

Wihohn BE. Identification of sulfonamide-hke adverse drug reactions to celecoxib in the World Health Organization database. Curr Med Res Opin 2001 17(3) 210-16. 

The adverse effects of iron formulations have resulted in trials to optimize dose regimens. A large database of clinical variance reports from Fresenius Medical Care North America (FMCNA) has been analysed to determine the incidence of suspected adverse drug reactions of iron dextran and the associated patient characteristics, dialysis practice patterns, and outcomes (8). A case-cohort design was used, comparing individuals who had suspected adverse drug reactions with the overall population. Out of 841 252 intravenous iron dextran administrations over 6 months, there were 165 reported suspected adverse drug... 

Figueras A, Estevez F, Laporte JR. New drugs, new adverse drug reactions, and bibliographic databases. Lancet 1999 353(9162) 1447-8. 

Another new feature of this edition is the introduction of the DoTS method of classifying adverse drug reactions, based on the Dose at which they occur relative to the beneficial dose, the Time-course of the reaction, and individual Susceptibility factors (see How to use this book ). This has been done for selected adverse effects, and I hope that as volumes of SEDA continue to be published and the Encyclopedia s electronic database is expanded, it will be possible to classify increasing numbers of adverse reactions in this way. 

Johnston, P.E. Morrow, J.D. Branch, R. Use of a Database Computer Program to Identify Trends in Reporting Adverse Drug Reactions. Am. J. Hosp. Pharm. 1990, 47, 1321-1327. 

---