17.3 Adverse Drug Reactions & Hypersensitivity Recognition
Key Takeaways
Adverse drug reactions are classified as Type A (augmented, dose-related, predictable) or Type B (bizarre, idiosyncratic, not dose-related)
Gell and Coombs hypersensitivity types are I (IgE-mediated, anaphylaxis), II (cytotoxic, haemolysis), III (immune-complex, serum sickness), IV (delayed T-cell, contact dermatitis and SJS/TEN), and V (receptor-mediated)
Penicillin cross-reactivity with cephalosporins is around 1–2% overall and higher with first-generation cephalosporins
Severe cutaneous adverse reactions — SJS, TEN, DRESS — present with mucosal involvement, skin blistering or peeling, and eosinophilia with organ involvement; stop the drug and refer urgently
First-line treatment for anaphylaxis is intramuscular adrenaline (epinephrine) 0.5 mg in the anterolateral thigh for adults
Adverse Drug Reactions — Type A vs Type B
An adverse drug reaction (ADR) is any noxious, unintended response to a medicine used at normal doses. The Rawlins-Thompson classification divides ADRs into two broad families that the DHA exam tests directly.
| Feature | Type A (Augmented) | Type B (Bizarre) |
|---|---|---|
| Relationship to dose | Dose-related, predictable | Not dose-related, unpredictable |
| Mechanism | Exaggerated normal pharmacological action | Idiosyncratic, immunological, genetic |
| Frequency | Common | Rare |
| Example | Bradycardia from a beta-blocker; bleeding from warfarin; hypoglycaemia from insulin | Anaphylaxis to penicillin; agranulocytosis from clozapine; SJS from sulfonamides |
| Management | Adjust dose; often reversible | Stop drug immediately; usually not re-challenged |
A practical rule: Type A is the drug doing its job too well; Type B is the drug doing something unexpected. Exam stems that describe a reaction at a therapeutic dose with a known pharmacological mechanism point to Type A; stems describing rash, anaphylaxis, or cytopenias in a small number of patients point to Type B.
Gell and Coombs Hypersensitivity Classification
The Gell and Coombs system classifies immunological drug reactions into five types.
Type I — Immediate, IgE-Mediated
- Mechanism: drug-IgE cross-linking on mast cells releases histamine and mediators within minutes to hours.
- Manifestations: urticaria, angioedema, bronchospasm, anaphylaxis.
- Classic drugs: penicillin, cephalosporins, iodinated contrast, latex, some muscle relaxants.
- Skin test: prick testing may detect specific IgE.
Type II — Cytotoxic
- Mechanism: IgG or IgM binds drug on a cell surface; complement lyses the cell.
- Manifestations: haemolytic anaemia (e.g. methyldopa, penicillin high-dose), thrombocytopenia (heparin-induced thrombocytopenia, quinine), neutropenia.
- Timing: hours to days.
Type III — Immune-Complex
- Mechanism: drug-antibody complexes deposit in tissues and activate complement.
- Manifestations: serum sickness — fever, arthralgia, urticarial rash, lymphadenopathy; drug-induced vasculitis; interstitial nephritis.
- Classic drugs: penicillin, sulfonamides, antithymocyte globulin.
- Timing: 1–3 weeks after exposure.
Type IV — Delayed, T-Cell Mediated
- Mechanism: sensitised T-cells react to drug antigen presented in skin or tissue.
- Manifestations: contact dermatitis (topical antibiotics, nickel), maculopapular drug rash, and the severe cutaneous adverse reactions Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
- Timing: 2–14 days.
- Classic drugs for SJS/TEN: sulfonamides, allopurinol, anticonvulsants (carbamazepine, lamotrigine, phenytoin), nevirapine, NSAIDs (oxicam class).
Type V — Receptor-Mediated (Anti-Receptor Antibody)
- Mechanism: autoantibodies bind and stimulate or block a cell-surface receptor.
- Examples: Graves disease (anti-TSH receptor stimulating antibody); myasthenia gravis (anti-AChR blocking antibody). Drug-induced versions are rare but the classification is tested.
Penicillin–Cephalosporin Cross-Reactivity
A frequently tested calculation: the overall cross-reactivity between penicillin and cephalosporins is approximately 1–2%, and is driven mainly by shared side-chain similarity rather than the beta-lactam ring itself. Cross-reactivity is higher with first-generation cephalosporins (e.g. cephalexin, cefazolin) and much lower with third- and fourth-generation agents (e.g. ceftriaxone, cefepime). A patient with a confirmed IgE-mediated penicillin allergy should not receive a first-generation cephalosporin without allergy assessment; later-generation cephalosporins are often tolerated.
Severe Cutaneous Adverse Reactions (SCARs)
Three SCARs are exam-critical:
| Reaction | Hallmarks | Mortality |
|---|---|---|
| Stevens-Johnson syndrome (SJS) | <10% body surface area skin detachment; target lesions; mucosal involvement (oral, conjunctival, urogenital) | ~5–10% |
| Toxic epidermal necrolysis (TEN) | >30% BSA detachment; full-thickness epidermal necrosis; SJS-TEN overlap = 10–30% BSA | ~25–35% |
| DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) | Rash, fever, eosinophilia, lymphadenopathy, liver injury; onset 2–8 weeks after drug start | ~10% |
Red Flags That Demand Immediate Action
- Mucosal involvement: oral blisters, painful swallowing, conjunctivitis, genital ulceration.
- Skin blistering or peeling: positive Nikolsky sign (epidermis shears with lateral pressure).
- Eosinophilia with organ involvement (liver, kidney, lung): think DRESS.
- Rapid progression, fever, facial oedema.
The pharmacist's response to any suspected SCAR is: stop the suspected drug immediately, document, and refer the patient for urgent medical assessment — never re-challenge, never taper. Common culprit drugs (sulfonamides, allopurinol, carbamazepine, lamotrigine, phenytoin, nevirapine) should be flagged on the patient's profile for life.
Anaphylaxis
Anaphylaxis is a severe, life-threatening Type I hypersensitivity reaction with rapid onset. Diagnostic criteria include skin/mucosal change PLUS respiratory compromise OR hypotension OR gastrointestinal symptoms after a known allergen.
First-Line Treatment
- Adrenaline (epinephrine) IM 0.5 mg (0.5 mL of 1:1000) in the anterolateral thigh for adults. Repeat every 5 minutes if no response.
- NOT IV adrenaline in the first instance; IV adrenaline is reserved for refractory anaphylaxis in a monitored setting.
- Airway, oxygen, IV fluid resuscitation; lay the patient flat with legs raised (not sitting up).
- Adjuncts: antihistamine (e.g. chlorphenamine), corticosteroid (e.g. hydrocortisone 200 mg IV) — these are second-line and do not replace adrenaline.
- After stabilisation: observe for biphasic reaction for at least 6–12 hours; consider an adrenaline auto-injector for discharge and an allergy referral.
A common exam trap asks which drug is first-line for anaphylaxis — the answer is always IM adrenaline. Antihistamines and steroids are adjuncts; they will not abort anaphylaxis. A second trap offers IV adrenaline as the first-line option — this is wrong for initial treatment; IV adrenaline is reserved for refractory anaphylaxis in a monitored setting because dosing errors and arrhythmias are common. A third trap asks where to inject — the anterolateral thigh (vastus lateralis) gives the fastest rise in plasma concentration; subcutaneous injection is slower and not recommended in acute anaphylaxis.
A patient on long-term metoprolol for ischaemic heart disease presents with a heart rate of 38 bpm and dizziness after the dose was doubled. Which adverse reaction classification best describes this?
Type A (augmented) dose-related reaction
Type B (bizarre) idiosyncratic reaction
Type IV delayed hypersensitivity
Type II cytotoxic reaction
A patient develops oral blisters, painful conjunctivitis, and target-shaped skin lesions 10 days after starting sulfamethoxazole-trimethoprim for a urinary tract infection. What is the most appropriate pharmacist action?
Counsel the patient to continue the course and apply a topical emollient
Reduce the sulfamethoxazole-trimethoprim dose by half and review in 48 hours
Switch to a different sulfonamide antibiotic to complete the course
Stop the drug immediately, document the reaction as suspected Stevens-Johnson syndrome, and refer for urgent medical assessment
A 30-year-old receives the first dose of an antibiotic and within 20 minutes develops urticaria, throat tightness, and a systolic blood pressure of 78 mmHg. Which is the correct first-line treatment?
Oral loratadine 10 mg immediately and observe for one hour
IV hydrocortisone 200 mg as the sole agent
Intramuscular adrenaline 0.5 mg into the anterolateral thigh
Nebulised salbutamol alone
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