Adverse drug reactions epidemiology

Hoigne R, Lawson DH, Weber E. Risk factors for adverse drug reactions — epidemiological approaches. Eur J Clin Pharmacol 1990 39 321-5. 

The presence of the combined alleles Ml and Tl, which mark deficiencies in glutathione-5-transferase genes, increases susceptibility to tacrine hepatotoxicity (5). It would be interesting to use this molecular epidemiological approach to identify the role of combinations of glutathione-S-transferase genotypes in other adverse drug reactions. 

Smith JW, Seidl LG, Cluff LE. Studies on the epidemiology of adverse drug reactions. V. Clinical factors influencing susceptibility. Ann Intern Med 1966 65 629-40. 

Atkin, P.A. Veitch, P.C. Veitch, E.M. Ogle, S.J. The epidemiology of serious adverse drug reactions among the elderly. Drugs Aging 1999,14 (2), 141-152. 

Beyth, R.J. Shorr, R.I. Epidemiology of adverse drug reactions in the elderly by drug class. Drugs Aging 1999, 14 (3), 231-239. 

Wilholm BE, Myrhed M, Ekmau E. Trends and patterns in adverse drug reactions to non-steroidal anti-inflammatory drugs reported in Sweden. In Rainsford KD, Velo GP, editors. Side-effects of Anti-inflammatory Drugs, Part I. Clinical and Epidemiological Aspects. Lancaster MTP Press, 1987 55. 

Collins GE, Clay MM, Falletta JM. 1974. A prospective study of the epidemiology of adverse drug reactions in paediatric hematology and oncology patients. Am. J. Hosp. Pharm. 31 968—975. 

Japanese labeling regulations require that animal data and data from other members of the same chemical or pharmacological class of drugs should be included, even when these allude to adverse drug reactions (ADR) that have not actually been observed for the product that is labeled. When direct drug attributability of an ADR has not been established, it remains a requirement that other indirectly obtained information must still be included this would include epidemiological information or pharmacodynamic effects observed in normal volunteer studies. ADR frequencies (section 4, Table 1) may be presented in a table, usually for all adverse event types reported with frequencies > 5%, between 0.1-5%, and < 0.1%. 

Magro L, Moretti U. Leone R Epidemiology and characteristics of adverse drug reactions caused by drug-drug interactions. Expert Opin Drug Saf 2012 11 83-94. 

Stern RS, Steinberg LA. Epidemiology of adverse cutaneous reactions to drugs. Dermatoepidemiology 1995 13 681-688. 

A further group of adverse reactions to drugs are those only recognisable by statistical methods, the so-called hidden risks. To establish the relationship, e.g. an increase of the occurrence of a disease or laboratory finding during administration of a specific drug, systematic epidemiological research is necessary. 

Strong suspicions of dependence should be reported always. Without such signals improvements in drug use will not be initiated there is no such thing as a false signal Work to establish the nature of the causality and other clinical and epidemiological features of drug adverse reaction relationship will always be necessary. 

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