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Monitoring of Suspected Adverse Drug Reactions in Oncology Unit ...

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International Journal <strong>of</strong> Research <strong>in</strong> Pharmaceutical and Biomedical Sciences ISSN: 2229-3701<br />

e.g. Fetal hydanto<strong>in</strong> syndrome and phenyto<strong>in</strong>.<br />

Types <strong>of</strong> allergic reactions [Guglielmi L, et al, 2006; Gruchalla R, 2000]<br />

Type I Immediate, anaphylactic.<br />

e.g. Anaphylaxis with penicill<strong>in</strong>s.<br />

<br />

<br />

<br />

Type II : Antibody (IgG, IgM) dependent cellular toxicity.<br />

e.g. Methyldopa and hemolytic anemia.<br />

Type III : Serum sickness type; mediated by deposition <strong>of</strong> antigen antibody complex.<br />

e.g. Proca<strong>in</strong>amide and drug-<strong>in</strong>duced lupus.<br />

Type IV : Delayed hypersensitivity type.<br />

e.g. Contact dermatitis.<br />

Serious adverse drug reaction [Knowles S & Shapiro L, 1997]<br />

Any adverse experience that results <strong>in</strong> one <strong>of</strong> the follow<strong>in</strong>g outcomes: death, a life-threaten<strong>in</strong>g<br />

experience, <strong>in</strong>-patient hospitalization or prolongation <strong>of</strong> exist<strong>in</strong>g hospitalization, a persistent or significant<br />

disability/<strong>in</strong>capacity, or a congenital anomaly/birth defect. Important medical events that may not result <strong>in</strong><br />

death, be life-threaten<strong>in</strong>g or require hospitalization may be considered as serious adverse event when, based<br />

upon appropriate medical judgment, they may jeopardize the subject and may require <strong>in</strong>tervention to<br />

prevent one <strong>of</strong> the outcomes listed.<br />

Delayed adverse effects <strong>of</strong> drugs<br />

A number <strong>of</strong> adverse effects may only become apparent after long-term treatment, such as the relatively<br />

harmless melan<strong>in</strong> deposits <strong>in</strong> the lens and cornea that are seen after years <strong>of</strong> phenothiaz<strong>in</strong>e treatment (and<br />

which should be dist<strong>in</strong>guished from pigmentary ret<strong>in</strong>opathy). Other examples <strong>in</strong>clude the development <strong>of</strong><br />

vag<strong>in</strong>al carc<strong>in</strong>oma <strong>in</strong> the daughters <strong>of</strong> women given diethylstilbestrol dur<strong>in</strong>g pregnancy for the treatment <strong>of</strong><br />

threatened abortion; and immunosuppressives and chemotherapeutic agents which can <strong>in</strong>duce malignancies<br />

that may not be apparent until years after treatment has been given.<br />

<strong>Adverse</strong> effects associated with drug withdrawal<br />

Some drugs cause symptoms when treatment is stopped abruptly, for example the benzodiazep<strong>in</strong>e<br />

withdrawal syndrome, rebound hypertension follow<strong>in</strong>g discont<strong>in</strong>uation <strong>of</strong> antihypertensives such as<br />

clonid<strong>in</strong>e, and the acute adrenal <strong>in</strong>sufficiency that may be precipitated by the abrupt withdrawal <strong>of</strong><br />

corticosteroids. These are all Type A reactions.<br />

Common therapeutic groups caus<strong>in</strong>g adverse drug reactions<br />

These are as follows:<br />

• Antibiotics<br />

• Ant<strong>in</strong>eoplastics<br />

• Anticoagulants<br />

• Antiarrythmics<br />

• Oral hypoglycemics<br />

• Antihypertensives<br />

• Non-steroidal anti-<strong>in</strong>flammatory drugs (NSAIDs) / Analgesics<br />

Vol. 1 (2) Oct – Dec 2010 www.ijrpbsonl<strong>in</strong>e.com 4

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