Adverse Reactions to Drugs and

Every country needs an authoritative, independent, competent and reliable system for evaluating adverse reactions to drugs and vaccines - a system that is linked with and provides support for the national drug regulatory authority (NRA) and for the national ministry of health. More than 80 countries... 

It is well documented that certain viral infections are associated with the induction and/or exacerbation of allergic reactions [84-86]. Moreover, infection with HCV, HAV and HBV can be associated with increased IgE levels [30, 31] and certain allergic manifestations [28]. In addition, HIV-1 infection can be associated with increased IgE levels [33-42] and augmented prevalence of adverse reactions to drugs and urticarial rash [47-48], Similarly, certain bacterial infections (e.g. S. aureus) can exacerbate atopic dermatitis [62-64], certain forms of allergic rhinitis [65, 66], and asthma [87], Therefore, it appears that viral and bacterial infections can be involved in the induction and/or exacerbation of respiratory and skin allergies. 

Adverse drug reactions present a major clinical problem. It has been estimated that up to 5% of all admissions to hospital result from adverse reactions to drugs and in hospital up to 20% of patients experience an adverse reaction. 

Adverse Reactions to Drugs and Drug Allergy Scope of This Book... 

Adverse reactions to drugs differ in both type and incidence in the pediatric population. Because of immature metabolic pathways, infants and children may have different metabolic patterns than adults. This at least partially explains why neonates require lower theophylline serum concentrations for the treatment of neonatal apnea and why the incidence of hepatotoxi-city following acetaminophen overdose is much lower in young children than in adults [44,45]. Antibiotic adverse effects unique to the pediatric population may... 

Weiner, M. and Bernstein, I.L. (1989). Adverse Reactions to Drug Formulation Agents. Marcel Dekker, New York. 

Adverse reactions to medications and the reporting of problems with drug products are also of great concern to the EDA. Fharmacists are essential participants in dealing with this concern along with other healthcare professionals. 

Stem, R.S. and Bigby M., An expanded profile of cutaneous reactions to nonsteroidal antiinflammatory dmgs reports to a specialty-based system for spontaneous reporting of adverse reactions to drugs, JAMA, 252,1433-1437,1984. 

The CSD had also started studies of adverse reactions to drugs (ADRs) by the beginning of 1964. Sir Derrick Dunlop wrote to aU the doctors (4 May 1964) and dentists (15 June 1964), inviting them... 

In some drug reactions, several of these hypersensitivity responses may present simultaneously. Some adverse reactions to drugs may be mistakenly classified as allergic or immune when they are actually genetic deficiency states or are idiosyncratic and not mediated by immune mechanisms (eg, hemolysis due to primaquine in glucose-6-phosphate dehydrogenase deficiency, or aplastic anemia caused by chloramphenicol). 

Cribb AE, Lee BL, Trepanier LA, et al. Adverse reactions to sulphonamide and sulphonamide-trimethoprim antimicrobials clinical syndromes and pathogenesis. Adverse Drug React Toxicol Rev 1996 15 9-50. 

Bosso, J.V. and Simon, R.A. 2008. Urticaria, angiodema, and anaphylaxis provoked by food and drug additives. In Food Allergy. Adverse Reactions to Foods and Food Additives, 4th ed., D.D. Metcalfe, H.A. Sampson, and R.A. Simon, Eds., pp. 340-352. Blackwell Publishing, New York. 

Elderly individuals often develop adverse reactions to drugs at dosage levels well tolerated by younger persons. These reactions may be due to an age-related increase in sensitivity to drugs or impairment of detoxification (metabolism) and excretion functions. 

It is becoming increasingly evident that a number of adverse reactions to drugs are due to genetically transmitted inborn enzyme abnormalities or deficiencies. The best known example of this category is the hereditary relative deficiency of the enzyme glucose-6-phosphate-dehydrogenase (G-6-PD), which occurs in 5% to 10% of Mediterranean littoral races, blacks, Pakistanis, and Sephardic Jews. This condition renders affected individuals susceptible to acute hemolytic ane-... 

Blood dyscrasias, mostly dose independent, are among the most important allergic-type adverse reactions to drugs. Aplastic anemia is a serious but rare (presumably) idiosyncratic reaction. It has been reported in association with chloramphenicol, quinacrine, phenylbutazone, mephenytoin, gold compounds, and potassium chlorate. Hemolytic anemia, thrombocytopenia, and agranulocytosis may result from an unusual, acquired sensitivity to a variety of widely used drugs including aminopyrine, phenylbutazone, phenothiazines, propylthiouracil, diphenylhydantoin, penicillins, chloramphenicol, sulfisoxazole, and tolbutamide. 

IV. COLLECTION, EVALUATION, AND REPORTING OF ADVERSE REACTIONS TO DRUGS... 

Adverse reactions to drugs will be more instantaneous and serious, too (example penicillin allergy)... 

Voluntary reporting. Doctors, nurses and pharmacists are supplied with cards on which to record suspected adverse reaction to drugs. In the UK, this is called the Yellow Card system and the Committee on Safety of Medicines collates the results and advises the government s Medicines Control Agency. It is recommended that for ... 

It is not enough to measure the incidence of adverse reactions to drugs, their nature and their severity, though accurate data are obviously useful. It is necessary to take, or to try to take, into account which effects are avoidable (by skilled choice and use) and which are unavoidable (inherent in drug or patient). Also, different adverse effects can matter to a different degree to different people. 

In a similar report from Turkey, adverse reactions to drugs led to withdrawal of one or more drugs in 62 of 158 patients (39%) (4). Outcomes were favorable and cultures became negative in 95% of the patients within 2 months. 

Japanese Ministry of Health and Welfare. Information on adverse reaction to drugs. Japan Med Gaz 1980 April 20 10. 

Fellner MJ. Adverse reactions to penicillin and related drugs. Clin Dermatol 1986 4(1) 133-41. 

Anonymous. Mucormycosis induced by deferoxamine mesylate. Information on Adverse Reactions to Drugs. Japan Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, February 1988. 

The acetylator phenotype of a patient can affect the frequency and severity of adverse reactions to drugs that are metabolized by acetylation (66,164,165). 

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