[Adverse reactions from angiotensin-converting enzyme inhibitor drugs reported by the yellow card].

BACKGROUND

The aim of the present study was to analyze the adverse reactions (AR) to captopril (CP) and enalapril (EN) reported by voluntary notification by the yellow card (YC) over the first five years of the foundation of the Drug Surveillance Center of the Valencian Community.

METHODS

The AR described were classified by organs and systems, evaluating the age and the sex of the patient, the indication for the drug, dosage 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 the same. The rates of notification were calculated with respect to the consumption of both drugs, expressed in daily dosage defined (DDD).

RESULTS

Two hundred one YC were evaluated, 111 for CP and 90 for EN referring 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 female sex, being usually slight and with 80% having been notified from primary health care centers.

CONCLUSIONS

The high number of reports of 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 favorable safety profile of this pharmacologic group, or, to the contrary, be a consequence of the under-reporting of adverse reactions.