[Adverse reactions from angiotensin-converting enzyme inhibitor drugs reported by the yellow card]. 1994

F J Morales-Olivas, and J M Ferrer, and V Palop, and E Rubio
Departamento de Farmacología, Universitat de València.

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.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D011358 Product Surveillance, Postmarketing Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale. Drug Surveillance, Postmarketing,Evaluation Studies, Postmarketing,Postmarketing Product Surveillance,Product Surveillance, Post-Marketing,Drug Surveillances, Postmarketing,Evaluation Study, Postmarketing,Post-Marketing Product Surveillance,Post-Marketing Product Surveillances,Postmarketing Drug Surveillance,Postmarketing Drug Surveillances,Postmarketing Evaluation Studies,Postmarketing Evaluation Study,Postmarketing Product Surveillances,Product Surveillance, Post Marketing,Product Surveillances, Post-Marketing,Product Surveillances, Postmarketing,Studies, Postmarketing Evaluation,Study, Postmarketing Evaluation,Surveillance, Post-Marketing Product,Surveillance, Postmarketing Drug,Surveillance, Postmarketing Product,Surveillances, Post-Marketing Product,Surveillances, Postmarketing Drug,Surveillances, Postmarketing Product
D002216 Captopril A potent and specific inhibitor of PEPTIDYL-DIPEPTIDASE A. It blocks the conversion of ANGIOTENSIN I to ANGIOTENSIN II, a vasoconstrictor and important regulator of arterial blood pressure. Captopril acts to suppress the RENIN-ANGIOTENSIN SYSTEM and inhibits pressure responses to exogenous angiotensin. (S)-1-(3-Mercapto-2-methyl-1-oxopropyl)-L-proline,Capoten,Lopirin,SQ-14,225,SQ-14,534,SQ-14225,SQ-14534,SQ 14,225,SQ 14,534,SQ 14225,SQ 14534,SQ14,225,SQ14,534,SQ14225,SQ14534
D004363 Drug Utilization The utilization of drugs as reported in individual hospital studies, FDA studies, marketing, or consumption, etc. This includes drug stockpiling, and patient drug profiles. Utilization, Drug,Drug Utilizations,Utilizations, Drug
D004656 Enalapril An angiotensin-converting enzyme inhibitor that is used to treat HYPERTENSION and HEART FAILURE. Enalapril Maleate,MK-421,MK421,Renitec,Renitek,MK 421,Maleate, Enalapril
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D000368 Aged A person 65 years of age or older. For a person older than 79 years, AGED, 80 AND OVER is available. Elderly

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