[Medical and socio-economical impact of drug-induced adverse reactions].
OBJECTIVE
To analyse the nature of adverse drug reactions, their frequency, the drugs incriminated, their outcome, the different ways to treat them and their cost.


METHODS
Descriptive, prospective and non-comparative study, based on spontaneous reporting. Each patient was followed-up over a 6-month period.


RESULTS
One hundred and fifteen adverse events were reported in 113 patients (58 men and 55 women), with a mean age of 59.5 years. Cutaneous and haematological reactions predominated, with a majority of cardiovascular and psychotropic agents incriminated. Sixty-three percent of adverse reactions were serious: 49% led to (or prolonged) hospitalisation, 6% led to death, 4% to after effects, 3% were life-threatening and 1% led to congenital malformation. The mean duration of an adverse reaction was of 37.4 days. The total cost of these 115 adverse reactions was an estimated 610.110 Euros, with a mean global cost of 5.305 Euros per event.


CONCLUSIONS
This study shows the individual and collective extent of the impact of adverse individual and collective reactions.
Apretna
Edwige
E
Centre de pharmacovigilance, EA3676 MPSS, Université Victor Segalen Bordeaux 2, CHU de Bordeaux 33076, France.
Haramburu
Françoise
F
Taboulet
Florence
F
Bégaud
Bernard
B
D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000191:economics; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D003365:Costs and Cost Analysis; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005500:Follow-Up Studies; D005602:France; D006760:Hospitalization; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012959:Socioeconomic Factors; D013997:Time Factors