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Adverse Drug Reactions I

I. Definitions of Adverse Drug Reactions
II. Adverse Drug Events
III. ADRs and Legislation
IV. Reporting and Surveilance of ADRs
V. Causality - Strength of Association
VI. Temporal Sequence
VII. Algorithms - probability
VIII Identifying ADRs
IX. Types of ADRs
X. Immunologic Classification of ADRs

serious ADRs must be reported within * days15
unexpected ADRs must be reported within * days3
serious and unexpected ADRs must be reported toFDA
Prohibits mislabeling and adulteration of drugsPure Food and Drug Act 1906
new drugs must be safe and pure; did not have to show efficacyFood Drug and Cosmetic Act 1938
Proof of efficacy and safety; est guidelines for reporting ADR infoKefauver Harris Ammendment 1962
why did the kefauver harris ammendment become established?Thalidomide and I-tryptophan -> kids without arms and eosinophillic myalgia
dechallengept. stops med and ADR decreases
rechallengeafter resolution, med restarted -> ADR reoccurs
temporal sequences/s do not start prior to administration
Naranjoprobability; used most, add scores based on questions
ways to identify ADRsliterature citations, FDA programs, Manufacturer, Post marketing surveillance
FDA approval and phase III trialsmay not enroll enough pt. or be carried out over along enough period of time to detect a rare ADR that may occur in <1000 pts.
felbamate (1993)anticonvulsant ->aplastic anemia after 6 mo. on market
oral contraceptivesassd. with pulmonary embolism (3years)
slindamycinassd. with pseudomembranous colitis (5years)
post marketing surveilanceneed an inc. population to detect rare ADRs and high risk pops. not always studied in clinical trials
types of Predictable ADRsdirect extension, unwanted but inseparable, secondary or indirect
example of direct extension ADRdec. blood sugar with sulfonylureas
example of umwanted but inseparable pharm. effectdry mouth with anticholinergenic; sedation with antihistamine
example of secondary or indirect ADR; not related to primary actioncandiasis with inhaled steroids
types of unpredictable ADRsintolerance, allergic or hypersensitivity, idiosyncratic
example of intolerancetinitus with aspirin; syncope with alpha blockers
example of immediate allergic or hypersensitive rxnanaphylaxis, dec BP, edema (onset ,1hr)
example of accelerated allergic or hypersensitive rxnuticaria, edema, wheezing (onset, 1-72hr)
example of late allergic or hypersensitive rxnmorbilliform rash (onset >72hr)
type of pseudoallergic ADRNSAIDS -> aseptic neningitis; not assd with any known pharm effects or allergic mech.
example of genetic predisposition to ADRG-6-PD, slow/fast acetylator (give less/more respectively)
example of opposite effect ADRexcitation with barbituates in peds.; seizures with antihistamines in peds
immuno classifications of ADRsI. anaphylactic, II. cytotoxic, III. immunocomplex, IV. cell mediated
mediators of anaphylaxisIgE Ab; mast cells (primarily) and basophils for chemotaxis
time of onset for anaphylaxis<1hr
antigen stimulus for anaphylactic rxndrug, metabolite, setum protein
actions of anaphylaxisvasodil. enhanced perm. of cap. ->uticaria; sm. mm. contract. ->bronchospasm; vd ->dec BP -> shock
what causes sm. mm. contraction in anaphylaxis?histamine
example of anaphylaxisasthma
caused by mediatorsanaphylaxis
IgG, IgM, or Complement assd; not caused by mediatorscytotoxic reactions
effects of cytotoxic reactionsdamage directed toward cell membrane (eg. platelets, WBCs, RBCs)
what is the antigen stimulus for cytotoxic rxnsdrug or metabolite, and protein and Ab; antigen + Ab complex = cell destruction
causes deposition of antigen-Ab complexes on the tissuesimmunocomplex rxn
example of immunocomplex rxnsserum sickness; vasculitis; SLE; glomerular nephritis
delayed hypersensitivity; assd. with T-lymph -> rls lymphokinescell-mediated reaction
example of cell-mediated rxncontact dermatitis; photosensitivity
PPD (mantoux) testbased on CMI; how long takes cell to get there (48-72hr); cell-med. immun.
imability to respond to various stimulusanergy
type A; AugmentedPredictable ADR
type B; Bizarreunpredictable ADR

Suzanne M. Clous

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