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Research Articles and Papers on:

Adverse Drug Reactions


Adverse drug reactions as cause of admission to hospital: prospective analysis of 18,820 patients

Munir Pirmohamed, Sally James, Shaun Meakin,  Chris Green,, Andrew K Scott, Thomas J Walley,  Keith Farrar, B Kevin Park,  Alasdair M Breckenridge

1 Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool L69 3GE, 2 Royal Liverpool University Hospital, Liverpool L7 8XP, 3 Wirral Hospitals NHS Trust, Wirral CH49 5PE

Abstract taken from:
BMJ  2004;329:15-19 (3 July)

Objective: To ascertain the current burden of adverse drug reactions (ADRs) through a prospective analysis of all admissions to hospital. 

Design: Prospective observational study. 

Setting: Two large general hospitals in Merseyside, England. 

Participants: 18,820 patients aged more than 16 years admitted over six months and assessed for cause of admission. 

Main outcome measures: Prevalence of admissions due to an ADR, length of stay, avoidability, and outcome. 

Results: There were 1225 admissions related to an ADR, giving a prevalence of 6.5%, with the ADR directly leading to the admission in 80% of cases. The average bed stay was eight days, accounting for 4% of the hospital bed capacity. The projected annual cost of such admissions to the NHS is £466m. The overall fatality was 0.15%. Most reactions were either definitely or possibly avoidable. Drugs most commonly implicated in causing these admissions included low dose aspirin, diuretics, warfarin, and non-steroidal anti-inflammatory drugs other than aspirin, the most common reaction being gastrointestinal bleeding. 

Conclusion: The burden of ADRs on the NHS is high, accounting for considerable morbidity, mortality, and extra costs. Although many of the implicated drugs have proved benefit, measures need to be put into place to reduce the burden of ADRs and thereby further improve the benefit:harm ratio of the drugs.


Risk of myocardial infarction in patients takingcyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs: population based nested case-control analysis

Julia Hippisley-Cox and Carol Coupland -  BMJ 2005;330:1366 (11 June)

I know the title of this study is really technical but what it means is that the researchers were looking at people taking NSAID’S between 2000 and 2004.

What are the types of NSAID?

The study looked at rofecoxib, celecoxib, naproxen, ibuprofen, diclofenac, and other selective and non-selective NSAIDS.

There were 367 general practices taking part across England, Wales and Scotland and 9218 patients.

The researchers concluded that “These results suggest an increased risk of myocardian infarction associated with current use of rofecoxib, diclofenac and ibuprofen despite adjustment for many potential confounders.


Non-cardiac QTc-prolonging drugs and the risk of sudden cardiac death

Sabine M.J.M. Straus1,2,3, Miriam C.J.M. Sturkenboom1,2, Gysèle S. Bleumink1,4, Jeanne P. Dieleman1,2, Johan van der Lei2, Pieter A. de Graeff3,5, Jan Herre Kingma4,5 and Bruno H.Ch. Stricker1,4,*

European Heart Journal Advance.  Access originally published online on May 11, 2005

Aims: To assess the association between the use of non-cardiac QTc-prolonging drugs and the risk of sudden cardiac death.

Methods and results: A population-based case–control study was performed in the Integrated Primary Care Information (IPCI) project, a longitudinal observational database with complete medical records from more than 500,000 persons. All deaths between 1 January 1995 and 1 September 2003 were reviewed. Sudden cardiac death was classified based on the time between onset of cardiovascular symptoms and death. For each case, up to 10 random controls were matched for age, gender, date of sudden death, and general practice. The exposure of interest was the use of non-cardiac QTc-prolonging drugs. Exposure at the index date was categorized into three mutually exclusive groups of current use, past use, and non-use. The study population comprised 775 cases of sudden cardiac death and 6297 matched controls. Current use of any non-cardiac QTc-prolonging drug was associated with a significantly increased risk of sudden cardiac death (adjusted OR: 2.7; 95% CI: 1.6–4.7). The risk of death was highest in women and in recent starters.

Conclusion: The use of non-cardiac QTc-prolonging drugs in a general population is associated with an increased risk of sudden cardiac death.