ADVERSE DRUG REACTIONS - ADVERSEDRUG REACTIONS...

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    1 ADVERSE DRUG  REACTIONS Dr. V. Jagadeesan,  Former Deputy Director (Sr. Grade),  National Institute of Nutrition, Hyderabad 2. New Drug Approval Process. 
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    2 Definition (ICH/GCP  Guidelines) “All noxious and unintended responses to a medicinal  product related to any dose should be considered ADR” Multiple actions of therapeutic drugs are not always in  the best interest of the patient. In addition to the primary therapeutic effect for which the  drug is prescribed , the likelihood exists for the  emergence of concurrent or delayed or unwanted and  potentially harmful effects –  ADVERSE DRUG  REACTION ( ADR ) Any drug is therefore a double edged sword , doing good  on one hand and perhaps harm on the other 
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    3 Background  Impressive advances in Pharmacology. Ability to synthesise new, complex molecules  without commensurate knowledge of  how and  under what conditions they act in humans, the  question of - ADR and DRUG - DRUG INTERACTIONS Has become a serious subject of modern  therapeutics. So  EFFICACY  of the drug as well as its  SAFETY   are  being legislated
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    4 JAMA ,1998 ADRs –  one of the  major  causes of   death in hospitalised patients in USA. The incidence of ADRs of all severities  (serious and non serious ) . . 10.9% ** **  serious ADR ….. 6.7% ** **    fatal ADRs. .… 0.32 %
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    5 CLASSIFICATION OF ADR Dose dependent  Dose independent  Contd. .
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    6 CLASSIFICATION OF ADR DOSE DEPENDENT ADR (DD-ADR) If an active drug is administered in sufficiently large doses,  eventually all individuals will manifest adverse reactions. They are specific for the drug concerned . Examples: Known for unwanted pharmacologic effect( anti cholinergic  effects of phenothiazine tranquilizers ) Exaggerated therapeutic effects ( hypotension with anti  hypertensive drugs like clonidine and guanethidine when these  agents are taken at higher than usual doses)  Reactions unrelated to the therapeutic effects ( oto toxicity by  excessive doses of streptomycin )  Contd. .
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    7 CLASSIFICATION OF ADR Factors affecting DD-ADR Liver and kidney diseases. Enzyme abnormalities  Altered absorption  Competition for transport binding sites of action  Certain physiological conditions  ( see later )   Age  Dose dependent ADRs are more prominent at the  chronologic extremes of life . i.e. The foetus , the new born infant , and the aged are more 
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ADVERSE DRUG REACTIONS - ADVERSEDRUG REACTIONS...

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