World Health Organization Adverse Drug

WHO. Safety of medicine. A guide to detecting and reporting adverse drug reactions. Geneva World Health Organization 2002. (WHO/EDM/QSM/2002.2.)... 

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). 

World Health Organization Definitions—Causality Assessment of Suspected Adverse Drug Reactions... 

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. 

Because of the adverse effects of gossjrpol. The Special Program of Research, Development and Research Training in Human Reproduction (HRP) at the World Health Organization (WHO) decided that gossjrpol is not acceptable as an antifertility drug (2). 

The ADI (acceptable daily intake) is the level of daily intake of a particular substance that will not produce an adverse effect. The RfD (reference dose) is an estimate of the daily exposure level for the human population. The RfD development follows a stricter procedure than that followed for the ADI. This sometimes results in a lower value for the ADI. The ADI approach is used extensively by the Food and Drug Administration (FDA) and the World Health Organization (WHO), while the RfD is a contemporary replacement for the ADI used by the Environmental Protection Agency (ERA). 

The amount of the material that can be ingested without unreasonable risk of adverse health effects may be considered an acceptable daily intake. This refers primarily to food chemicals. To arrive at an acceptable daily intake, appropriate toxicological tests and safety factors are involved. ADIs have been established by the U.S. Food and Drug Administration, the World Health Organization, the Joint Expert Committee on Food Additives, and the European Economic Community. 

Drug-drug interactious Statins In a systematic screening of the World Health Organization s adverse drug reactions database, 53 cases of rhabdomyolysis with azithromycin and statins were investigated retrospectively [118 ]. Rhabdomyolysis occurred shortly after initial treatment with azithromycin in 23% of cases. In 11 patients an interaction was suggested. With the exception of one patient, the statins were prescribed at the recommended daily doses. 

---