Abstract
Many new chemical entities were marketed throughout the world in the past decade. Since only limited information is available prior to marketing of a new drug, it is extremely important to monitor the safety of these drugs. The rapid detection of adverse drug reactions has important public health implications. Acute side effects occur in approximately 5% of patients taking a drug.1 While most of these adverse drug reactions (ADRs) are mild and reversible (e. g., rashes, gastrointestinal distress), some cause significant morbidity and mortality. In addition, ADRs need to be detected, validated, and reported, so that clinicians can base a decision to administer a drug on known risks and benefits. While it probably unrealistic to think that any system might always avert tragedies such as the thalidomide episode2, the hope is that it might detect such problems early enough to reduce the number of affected individuals.3–7 Furthermore, new drugs need to be monitored for unknown beneficiai effects.
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Carson, J.L., Strom, B.L. (1992). Screening for Unknown Effects of Newly Marketed Drugs. In: Strom, B.L., Velo, G. (eds) Drug Epidemiology and Post-Marketing Surveillance. NATO ASI Series, vol 224. Springer, Boston, MA. https://doi.org/10.1007/978-1-4899-2587-9_10
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