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PubMed2002

[Risk of drug-induced agranulocytosis: an approximation to risk analysis arising from spontaneous notification of agranulocytosis cases among patients treated with calcium dobesilate].

BACKGROUND: Frequently, decisions about the safety of drugs are based on isolated cases of patients that develop a disease, while they have been taken a drug. A new method to detect, using spontaneous reporting, increases in agranulocytosis risk among patients treated with calcium dobesilate is shown. METHOD: Using data of dobesilate sales, the maximum number of patients treated in a year was calculated. Spontaneous reports of agranulocytosis associated to dobesilate notified along the period 1985-2000 were identified. The number and the maximum number of cases explained by the agranulocytosis risk in a general population were calculated using the distribution of Poisson, assuming several reporting rates. Similarly, the influence of number of patients older than 60 and the duration of exposure to the drug were analysed. RESULTS: The number of spontaneously reporting cases of agranulocytosis associated to dobesilate, in the period 1985-2000 was not greater than the maximum number of cases predicted by the agranulocytosis risk in a general population. Probably, a high number of dobesilate-treated patients had an advanced age and/or took the drug during several months. In these conditions, it is more difficult to identify an increase of risk associated to drug. CONCLUSIONS: To calculate the risk of agranulocytosis associated to a drug is required to consider the basal risk of agranulocytosis in a general population as well as its possible modifications in the population of patients treated with the drug.

Adverse Drug Reaction Reporting Systems↗
PubMed2000

Indonesia -- notification, reporting and disclosure.

The prevalence of HIV infection in Indonesia is generally held to be low. Since the first case was officially identified in 1987, only 1146 people have been diagnosed with HIV, 293 of them reported as having AIDS. The latest estimate from WHO (June 1999) is that 250,000 Indonesians are infected, giving a prevalence among this 200+ million population of around 120/100,000 population. This figure is generally agreed to be in the correct range--for sexual transmission of the virus. It is probable, however, that the total figure may be several times higher as a result of the sudden explosion of injecting drug use, with no surveillance and little outreach yet having been undertaken among this group.

Acquired Immunodeficiency Syndrome↗