Apr 6, 2014
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When a new drug is introduced, it has usually been studied only in relatively few patients – typically 1,500. If n patients have been studied, and no serious effects observed, there is still a chance of a serious adverse effect occurring in the general population as frequently as 3/n (1:500).

Adverse effects can be divided into types. First, those which are closely related to the concentration of the drug and accord with what is known of its PHARMACOLOGY. These so-called type A (augmented pharmacological) effects are distinguished from type B (bizarre) effects which are unpredictable, usually rare, and often severe. ANAPHYLAXIS is the most obvious of these; other examples include bone-marrow suppression with CO-TRIMOXAZOLE; hepatic failure (see HEPATITIS) with SODIUM VALPROATE; and PULMONARY FIBROSIS with AMIODARONE. A more comprehensive classification includes reactions type C (chronic effects), D (delayed effects – such as teratogenesis or carcinogenesis) and E (end-of-dose effects – withdrawal effects). Examples of adverse reactions include nausea, skin eruptions, jaundice, sleepiness and headaches.

While most reported adverse reactions are minor and require no treatment, patients should remind their doctors of any drug allergy or adverse effect they have suffered in the past. Medical warning bracelets are easily obtained. Doctors should report adverse effects to the authorities – in the case of Britain, to the Committee on Safety of Medicines (CSM), using the yellow-card reporting machinery.

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Medical Dictionary

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