Fj. Moralesolivas et al., ADVERSE REACTIONS BY ANGIOTENSIN CONVERTI NG-ENZYME INHIBITORS NOTIFIED BY THE YELLOW CARD, Medicina Clinica, 103(9), 1994, pp. 321-325
BACKGROUND: The aim of the present study was to analyze the adverse re
actions (AR) to captopril (CP) and enalapril (EN) reported by voluntar
y notification by the yellow card (YC) over the first five years of th
e foundation of the Drug Surveillance Center of the Valencian Communit
y. METHODS: The AR described were classified by organs and systems, ev
aluating the age and the sex of the patient, the indication for the dr
ug, dosis used, and the level of health care assistance received since
notification. Previous knowledge of the reported AR was analyzed, as
was the possible relation of causality with the drug and severity of t
he same. The rates of notification were calculated with respect to the
consumption of both drugs, expressed in daily dosis defined (DDD). RE
SULTS: Two hundred one YC were evaluated, 111 far CP and 90 for EN ref
erring 160 and 133 clinical manifestations, respectively. The rate of
notification was 2.51 YC/million DDD for CP and 5.57 for EN. The AR in
the respiratory tract were the most frequently reported with cases of
dry cough representing 33.7% of the total YC for CP and 33.8% for EN.
Cutaneous AR followed for both drugs. Angioedema was reported in 0.09
AR/million DDD for CP and 0.56 for EN. Reactions were most frequently
observed in patients over the age of 50 with a predominance of the fe
male sex, being usually slight and with 80% having been notified from
primary health care centers. CONCLUSIONS: The high number of reports o
f cough demonstrate that this is the most frequently observed adverse
reaction. The distribution of reactions and the characteristics of the
patients with the same coincide with other studies. The low number of
yellow cards reporting severe adverse reactions may support the favor
able safety profile of this pharmacologic group, or, to the contrary,
be a consequence of the under reporting of adverse reactions.