Unhelpful information about adverse drug reactions.

Drug treatment is an important part of managing chronic disease, but people often choose not to start or continue with recommended treatments. As the efficacy of a drug is central to the decision to start or continue treatment, accurate and succinct communication of the benefits of treatment is emphasised in clinical practice. But the disadvantages and adverse effects of drugs are also important. Concerns about adverse drug reactions—noxious and unintended effects of a drug (box 1)—can deter patients from starting treatment, 3 and their occurrence during treatment can prompt cessation. 5 Accurate information about adverse drug reactions, and its careful communication to patients, is likely to influence the outcomes of chronic disease management. An important concept in considering information about adverse drug reactions and its clinical impact is the nocebo effect, the phenomenon by which negative expectations promote adverse outcomes. Individuals who are aware they might get a certain side effect are more likely to experience it. Participants receiving placebo in clinical trials report adverse events that strongly align with those of the active comparator treatment. 10 Experimental data indicate that informing participants of the possibility of a certain symptom increases reporting of it, compared with participants who were not informed of the possible symptom. 12 Administration of inert treatments leads to high rates of symptom reporting that aligns with the information provided before treatment. Several symptoms, often referred to as “non-specific,” are commonly reported in nocebo research, including headache, musculoskeletal pain, difficulty concentrating, drowsiness, nausea, dizziness, fatigue, and insomnia. We extracted information from several sources about the number, type, and methods of presentation of adverse reactions for 15 commonly prescribed drugs—including metoprolol, simvastatin, celecoxib, lisinopril, and quetiapine—and assessed the relation between adverse reactions listed for these drugs and commonly experienced symptoms. We investigated a range of “real world” sources of drug information accessed by practitioners and patients, so we included both official (a regulatory agency and a government funded source) and unofficial (two popular internet sites and a patient centred website) sources (box 2). We discuss the importance and implications of the content and presentation of information about adverse drug reactions for clinical practice.