Chapter 1  ·  Module 4

Drug Safety and Adverse Effects

Section 1

Types of Adverse Drug Reactions

Type A

Dose-Dependent — Predictable

Extension of drug’s pharmacological action. Common. Managed by dose reduction. Examples: warfarin bleeding, insulin hypoglycemia, beta-blocker bradycardia.

Type B

Idiosyncratic — Unpredictable

Unrelated to drug mechanism. Rare. Often requires permanent discontinuation. Examples: isoniazid hepatotoxicity, chloramphenicol aplastic anemia, Stevens-Johnson syndrome.

Immediate Allergy

Minutes — IgE-Mediated

Urticaria, angioedema, anaphylaxis. Treat with epinephrine. Permanent avoidance. Classic example: penicillin anaphylaxis.

Delayed Allergy

Hours to Days — Cell-Mediated

Rash, contact dermatitis. Stevens-Johnson syndrome and toxic epidermal necrolysis are severe. Implicated drugs: allopurinol, sulfonamides, antiepileptics.

Section 2

Drug Interactions

Inhibition

Cytochrome P450 Inhibition → Raises Drug Levels → Toxicity Risk

Azole antifungals, macrolides, amiodarone, ritonavir, grapefruit juice inhibit hepatic enzymes. Object drug accumulates. Warfarin bleeding, statin myopathy, QT prolongation result.

Induction

Cytochrome P450 Induction → Lowers Drug Levels → Failure Risk

Rifampin, phenytoin, carbamazepine, phenobarbital, St. John’s wort accelerate metabolism. Oral contraceptive failure, antiretroviral failure, transplant rejection result.

Additive

Pharmacodynamic — Combined Effect Equals Sum

Exploited therapeutically (combination antihypertensives). Can generate additive toxicity (two QT-prolonging drugs causing torsades de pointes).

Synergistic

Pharmacodynamic — Combined Effect Exceeds Sum

Trimethoprim + sulfamethoxazole: each blocks a different step in bacterial folate synthesis. Together far more effective than either alone.

Antagonistic

Pharmacodynamic — Combined Effect Less Than Sum

Exploited in reversal: naloxone reverses opioids, flumazenil reverses benzodiazepines, protamine reverses heparin.

Section 3

Dangerous Combinations

Serotonin Syndrome

Monoamine oxidase inhibitors + selective serotonin reuptake inhibitors / tramadol / meperidine / linezolid

Excess synaptic serotonin → neuromuscular excitability (clonus, hyperreflexia), autonomic instability (hyperthermia, tachycardia), altered mental status. Potentially fatal. Two-week washout required between monoamine oxidase inhibitor and serotonergic drug.

Hypertensive Crisis

Monoamine oxidase inhibitors + tyramine-rich foods (aged cheese, cured meats, fermented foods)

Dietary tyramine normally degraded in gut by monoamine oxidase. When enzyme is blocked, tyramine absorbed intact → massive norepinephrine release → severe hypertension → risk of intracerebral hemorrhage. Dietary counseling is mandatory.

Torsades de Pointes

Two or more QT-prolonging drugs (antiarrhythmics + macrolides / fluoroquinolones / antipsychotics)

Additive QT interval prolongation → risk of fatal ventricular arrhythmia. Electrolyte abnormalities (low potassium, low magnesium) compound risk. Baseline electrocardiogram required before adding second QT-prolonging drug.

Respiratory Depression

Opioids + benzodiazepines (also: alcohol, non-benzodiazepine sedative-hypnotics)

Additive central nervous system and respiratory depression. Major contributor to drug overdose deaths. Avoid combination when possible. If necessary: lowest effective doses, explicit patient counseling, co-prescribe naloxone.

Section 4

Drug-Disease Contraindications

Drug Avoid in Mechanism of Harm
Beta-blockers Decompensated heart failure, high-degree atrioventricular block, severe asthma Reduce contractility; block atrioventricular conduction; beta-2 blockade causes bronchoconstriction
Non-steroidal anti-inflammatory drugs Heart failure, chronic kidney disease, volume depletion, active peptic ulcer disease Block prostaglandins maintaining renal perfusion; cause sodium retention worsening heart failure; damage gastric mucosa
Angiotensin-converting enzyme inhibitors Pregnancy, bilateral renal artery stenosis, history of angioedema Fetal renal toxicity; precipitate renal failure in stenotic kidneys; bradykinin accumulation causes angioedema
Metformin Severe renal impairment, tissue hypoxia states Accumulates when renal clearance reduced; inhibits lactate metabolism → lactic acidosis
Anticholinergics Narrow-angle glaucoma, urinary retention, benign prostatic hyperplasia Block aqueous humor drainage (acute glaucoma); relax detrusor, contract bladder neck (urinary retention)
Statins Pregnancy, active liver disease Cholesterol essential for fetal development (teratogenic); may worsen active hepatic disease