Info

cing reports from other sources involving patients given monotherapy.

The data, being devoid of a reliable numerator, cannot be used to calculate the incidence of the reaction. It is misleading to make numerical comparisons for the same reaction between different drugs or drug classes since many factors, other than the number of reports, are involved. These include the level of reporting and underreporting, the level of use of the drug in the population, variations in populations and the time the drug has been in clinical usage; the data are also frequently affected by biases due to media coverage, regulatory and professonal warnings and other extraneous factors.

Many additional factors influence the number of reports received for a particular drug and reaction. These factors include the seriousness of the reaction, the ease of recognition of the reaction, and the reporting requirements and practices in the country concerned.

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