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Lecture-19 ADRs - Adverse Drug Reactions All drugs have the...

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Adverse Drug Reactions All drugs have the potential to produce deleterious consequences. Even Hippocrates (400 BC) was aware of this: “Above all, do no harm”. Voltaire didn’t have a very high opinion of physicians stating “They poured drugs of which they knew little into bodies of which they knew less.” Before drugs are approved for use in the general populace, they are first tested in animals and then in selected populations of patients, to determine their efficacies and pharmacological profiles. Some adverse effects (the most common ones) are detected in these pre-market studies. Many more adverse effects of drugs are detected after the drug comes to market and is used by large numbers of patients over a long period of time, especially if the adverse drug effects are rare. A major impetus into the study of adverse reactions came from the thalidomide disaster of 1961.
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Thalidomide In 1961, physicians began noticing a sudden outbreak of children being born with deformities characterized by the upper portion of a limb being absent or poorly developed ( phocomelia ). These birth defects were soon associated with the use by pregnant women of a presumably safe new hypnotic called thalidomide . Use of thalidomide in the first trimester, when forelimb buds were developing, caused the deformities. This disaster led to the re-evaluation of the methodology and regulations applied to the testing of the safety of drugs. More stringent legislation was enacted in many countries to improve the likelihood that serious toxicity would be detected before drugs come to market.
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ADE versus ADR Some patients develop unwanted signs or symptoms during drug therapy (called adverse drug events; ADE). But is this due specifically to the drug therapy? If so, the reaction is called an adverse drug reaction (ADR). An ADR is any noxious, unintended or undesired effect of a drug that is observed at doses usually administered therapeutically. This does not include cases of drug overdose, drug abuse or therapeutic errors.
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