E-DRUG: Differences in Drug Datasheets (9)
The article by Andrew Herxheimer that Joel Lexchin mentioned is easy to find
using the Healthy Skepticism library search page:
Leaflets with NSAIDs do not warn users clearly ?a UK survey
Pharmaceutical Journal 1999;262:559-561
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 ³stomach² 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.
Dr Peter R Mansfield OAM BMBS
Director, Healthy Skepticism Inc
Visiting Research Fellow, University of Adelaide