Healthy Skepticism Library item: 6856

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Herxheimer A.
Leaflets with NSAIDs do not warn users clearly—a UK survey
Pharmaceutical Journal 1999; 262:559-561

Abstract:

AIM: To examine how far patient information leaflets (PILs) for non-steroidal anti-inflammatory drugs (NSAIDs) explain theirsafe use and warn about gastrointestinal side effects. DESIGN: Survey of PILs for 29 major NSAID preparations listed in the British National Formulary. OUTCOME MEASURES: Does the PIL explain that: (1) the NSAID relieves symptoms but does not influence the course of the disease, (2) the use of high doses or of the strongest drugs to obtain complete relief increases the risk of serious adverse effects, and (3) if any “stomach” symptom occurs, the patient should stop taking the medicine or at least reduce the dose, and seek advice? RESULTS: (1) Only 4 of the 29 PILs clearly explained that the NSAID only relieves symptoms. (2) None of the PILs discouraged efforts by the patient to obtain complete relief with the drug. (3) 13 of the 29 PILs did not mention stopping the medication if stomach symptoms occurred; 10 advised stopping only if serious symptoms occurred (i.e., bleeding or severe stomach pain); six advised stopping, and seeking advice if any stomach symptom occurred. CONCLUSION: The information in PILs should be more complete, clearer and consistent for all NSAIDs. This requires urgent efforts by the Medicines Control Agency and manufacturers.

Keywords:
*analytic survey/United Kingdom/patient education material/ nonsteroidal anti-inflammatory drugs/ NSAID/package inserts/EVALUATION OF PROMOTION: LABELLING AND PACKAGE INSERTS/INFORMATION FROM INDUSTRY: PATIENTS AND CONSUMERS/PROMOTIONAL TECHNIQUES: PACKAGE INSERTS