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Introducción y objetivo. El aumento de la prescripción de anticoagulantes orales ha provocado un aumento de hemorragias intracraneales, la reacción adversa más grave asociada a este grupo farmacológico. El objetivo del estudio es evaluar el carácter evitable de hemorragias intracraneales asociada a anticoagulantes orales que causan ingreso hospitalario en pacientes con fibrilación auricular. Método. Supervisión de las historias clínicas de los pacientes que ingresaron en los Hospitales Universitarios Virgen del Rocío (01/01/03 al 31/03/07) con hemorragia intracraneal y fibrilación auricular; considerando hemorragia intracraneal asociada a anticoagulantes orales aquellas con una relación ≥ posible al aplicar el algoritmo de causalidad del Sistema Español de Farmacovigilancia. Para valorar el carácter evitable de la hemorragia intracraneal se ha estudiado la relación beneficio/riesgo del uso de anticoagulantes orales. Resultados. Al menos 20/57 (35,1%) hemorragias intracraneales asociadas a anticoagulantes orales pudieron ser potencialmente evitables, de las cuales en 7/20 (35%) el desenlace fue mortal, presentando secuelas 8/13 (61,5%) de los supervivientes. El fármaco sospechoso de interaccionar con anticoagulantes orales referenciado con mayor frecuencia fue el omeprazol, 11/57 (19%), a pesar de estar documentada esta interacción como altamente probable en la bibliografía y en los protocolos del Hospital. Conclusiones. La relación beneficio/riesgo del uso de anticoagulantes orales, el control estricto del Índice Normalizado Internacional, junto con las posibles interacciones medicamentosas deben ser evaluadas de forma individualizada y periódicamente para minimizar el riesgo de hemorragia intracraneal, que en un porcentaje elevado de casos es una reacción adversa potencialmente evitable y mortal (AU)

Introduction and objectives: The increase in oral anticoagulants prescription has caused an increase in intracranial hemorrhages, the most adverse reaction to this pharmacological group. The objective of this study is to evaluate the avoidability of the intracranial hemorrhages associated with oral anticoagulants that require hospitalization of patients with atrial fibrillation. Methods: Survey of the medical histories of the patients who were hospitalized in the University Hospital «Virgen del Rocío» (from 01/01/03 to 03/31/07) with intracranial hemorrhages and atrial fibrillation, considering as intracranial hemorrhages associated with oral anticoagulants those with a probable relationship applying the causality algorithm of the Spanish Pharmacological Surveillance System. In order to evaluate the avoidability of the intracranial hemorrhage the risk/benefit ratio of the use of oral anticoagulants has been studied. Results: At least 20 out of 57 (35.1%) intracranial hemorrhages associated with oral anticoagulants were potentially avoidable, in 7 cases out of those 20 (35 %) death was the outcome, and in 8 out of the remaining 13 (61.5%) the survivors suffered after–effects. Omeprazole was the drug more frequently involved in interactions with oral anticoagulants in 11 out of 57 cases (19%) although this interaction is categorized as highly probable in the bibliography and the protocols of the Hospital. Conclusions: The risk / benefit ratio of oral anticoagulants, the strict control of the International Normalized Ratio and the possible drug interactions, must be assessed individually and regularly to minimize the risk of intracranial hemorrhage that is often a potentially avoidable lethal adverse event (AU)

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OBJECTIVES: To evaluate knowledge in the general population about the rational use of non-steroidal analgesic-antithermal-anti-inflammatory drugs (NSAIDs), and whether an informative intervention could improve their knowledge. DESIGN: An intervention study with a control group. The subjects were polled before and after intervention, which consisted in the passive distribution of informative leaflets on NSAIDs to the experimental group. The replies of the subjects of both groups were compared. SETTING: "Cerro del Aguila" (experimental group) and "Polígono Norte" (control) health districts in Sevilla. PARTICIPANTS: 348 inhabitants (174 from each district), selected for age and sex in line with the proportions on the Municipal Roll, with people under 15 excluded. MEASUREMENTS AND MAIN RESULTS: About 30% did not spontaneously remember any NSAID. Almost 90% did not spontaneously remember any medical reaction. Self-medication and/or consumption on the advice of non-qualified people were as common as medical prescription. CONCLUSIONS: Passive distribution of leaflets was useless as a way of improving users' knowledge of NSAIDs. The intervention needs to be actively carried out by the doctor, with consistency over time and back-up from other health educationalists.

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Drug-induced gingival hyperplasia is a well documented unwanted side effect within the literature. It has been associated with the use of three different types of pharmaceutical agents, including phenytoin, cyclosporine and calcium channel blocking agents. Amlodipine belongs to the dihydropyridine-derived calcium blocking agents that may cause the side effect of drug-induced gingival hyperplasia. In the present study the possible pathogenic mechanisms, clinical and histologic presentation and therapeutic indications of amlodipine-induced gingival hyperplasia are discussed.

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We report a case of a male who was treated with cephonicid because of a surgical complication. Serum-sickness like symptoms were diagnosed two weeks later. Medical references are discussed.

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OBJECTIVE: To discover the sort of adverse reactions to medication (ARM) notified by Primary Care doctors and identify the under-notification of those cases having special clinical-epidemiological interest. DESIGN: Retrospective study in which 2,597 ARM corresponding to 1,467 Yellow Cards (YC) were analysed. These were notified by Primary Care doctors to the Centro Andaluz de Farmacovigilancia (Andalusian Drug-watch centre) during the period from 1/6/90 to 31/12/92. To assess the seriousness of the ARM, their terminological classification and imputability, the criteria used in the WHO's international "Yellow Card" programme of spontaneous notification were followed. MEASUREMENTS AND MAIN RESULTS: 77.2% of all notifications were from Primary Care, of which 7.4% were of special interest due to their serious or novel character. However an undernotification of serious and well-known ARM was detected, such as digestive haemorrhages (1.07/10(6) inhibitants per year), anaphylactic shock (0.34/10(6) inhab/year), agranulocytosis (0.23/10(6) inhab/year) and aplastic anaemia (0.05/10(6) inhab/year), among others. CONCLUSIONS: Most of the main under-notified ARM are generated in the community but treated in hospital Casualty departments. Therefore it would be useful to develop specific Drug-watch programmes in the hospitals themselves.

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OBJECTIVE: To find how users identified non-steroidal analgesic/antipyretic/anti-inflammatory drugs (NSAID) and their adverse reactions, as well as where the prescriptions were obtained and where users inquired when in doubt. DESIGN: An observation study carried out by means of a structured questionnaire administered to 174 residents in our basic health area. SETTING: Cerro del Aguila Basic Health Area in Sevilla. PARTICIPANTS: The 174 residents, chosen at random, by quotas corresponding to the Census' demographic characteristics. People under 15 were excluded. MEASUREMENTS AND MAIN RESULTS: 32.2% had no spontaneous memory of having taken any NSAID: 86.8% did not remember any possible adverse reaction to medication. Only 49.3% of the NSAID declared were prescribed by a doctor. 17.8% took NSAID daily and 5.7% took more than one medicine containing NSAID every day. CONCLUSIONS: In our health area, health education, both to identify NSAID as a pharmacological group and any possible adverse reactions, needs to be strengthened.

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Enalapril produces an inhibition of the angiotensin-renin system, correlating the pre-therapy plasmatic renin activity with blood pressure decrease, during its administration. This does not always happen, data to the contrary existing in literature, suggesting that there are some other acting mechanisms. We studied 34 hypertensive patients, whose blood pressure levels were controlled by Enalapril at a mean dosage of 12.32 +/- 0.9. Determining plasmatic concentration of 6-keto PGF1a (a prostacyclin metabolite), T x B2 (a thromboxane A2 metabolite), their distribution, plasmatic renin activity and a radiological and biochemical study. We found a significant increase in their distribution and plasmatic renin at the end of the essay. The results suggest a possible double active mechanism: angiotension-renin and prostaglandins systems, owing to the imbalance occurring between prostacyclin and thromboxane, the first named being the most favoured. This, together with easy application and the lack of side effects, made this drug useful for treatment of blood hypertension.

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There is a pharmacokinetic interaction between digoxin and diazepam that increases the elimination half-life of digoxin. It may be due to a reduction of digoxin tissue concentrations and to an enhanced effect of diazepam on digoxin binding to plasma albumin. Diazepam (10(-5) M) also induces a positive inotropic effect in guinea-pig isolated atria. In a study of a possible pharmacodynamic interaction between both drugs, the inotropic response to digoxin has been examined in rat isolated atria in the presence of diazepam. The atria were kept in Tyrode at 37 degrees C, bubbled with 95% O2 and 5% CO2 and electrically stimulated at twice the threshold voltage. The results indicate that diazepam induces an inotropic effect at 10(-5) M (P less than 0.05) and reduces (P less than 0.05) at 10(-9), 10(-7) and 10(-5) M the inotropic response to digoxin (10(-5) M).

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