Emergency contraceptive pill safety profile. Comparison of the results of a follow-up study to those coming from spontaneous reporting.

BACKGROUND: The emergency contraceptive pill (ECP) containing levonorgestrel is dispensed without a prescription in Spain since 2009. An easy access could diminish unwanted pregnancies; however, there is a risk of misuse and, in any case, of developing some adverse events. The aim of the present study is to further learn the adverse effects of this ECP. METHODS: An ad hoc follow-up study was carried out in three community pharmacies in a city of Central Spain; the sample was composed of those women asking for the ECP; they were interviewed by telephone after at least a month since the last menses. We completed the safety profile obtained with that coming from spontaneous reporting in Spain. RESULTS: Out of 139 women surveyed, 113 developed any adverse event--two considered as severe; the most frequently reported events were menstrual disturbances, which accounted for 21% of all events. Through spontaneous reporting, 36 cases of whatever adverse events related to levonorgestrel as ECP were identified. Twenty-five cases were considered as severe. Both types of reaction and severity were significantly different in the follow-up study and in the spontaneous reporting. Some of the reactions identified, such as miscarriage, febrile neutropenia, and porphyria, are not included in the Summary of Product Characteristics. CONCLUSIONS: Levonorgestrel as an ECP is mostly safe. Attention should be paid to some severe events and particularly to those risk factors for them to appear. Combining spontaneous reporting with an ad hoc follow-up study, the whole safety profile of a given medication can be obtained.

Trends in the consumption of attention deficit hyperactivity disorder medications in Castilla y León (Spain): changes in the consumption pattern following the introduction of extended release methylphenidate.

BACKGROUND: Attention deficit hyperactivity disorder (ADHD) is the most diagnosed behavioural disorder in children and adolescents; prevalence has been estimated around 5%. Studies have shown an increase in the use of ADHD medications during the last years. The aim of the present study was to learn the pattern and the evolution of ADHD medication consumption in Castilla y León (Spain). METHOD: Consumption data for the period 1992-2009 were obtained from databases containing information upon consumption and cost of medications dispensed by pharmacies at the expense of the Spanish National Health System. The data were expressed in defined daily doses (DDDs) per 1000 inhabitants per day (DDD/1000 inhabitants/day). A model to forecast consumption was built. RESULTS: Attention deficit hyperactivity disorder medication consumption increased in Castilla y León from 0.1 DDD/1000 inhabitants/day in 1992 to 1.5 DDD/1000 inhabitants/day in 2009; expected consumption will reach 2.5 DDD/1000 inhabitants/day by 2013. The drugs accounting for this increase were mainly made up of methylphenidate preparations (1.4 DDD/1000 inhabitants/day in 2009). From 1992 to 1999, there was a slight reduction in methylphenidate use; following amphetamine withdrawal, the consumption of stimulants began to increase, and figures showed a sharp rise after marketing of extended-release formulations in 2003. CONCLUSIONS: There has been an enormous increase in ADHD medication consumption in Castilla y León in the last few years; increase rocketed when extended-release methylphenidate was marketed. A rapid increase in the consumption is a warning on possible overdiagnosis and inappropriate prescription.

Risk excess of mortality and use of antipsychotics: a case-noncase study.

Severe mental disorders are associated with an increased mortality risk and the use of antipsychotic drugs may be one of the causes. In this study, we addressed the potential association of the reported mortality among patients on antipsychotics compared to other drugs from a pharmacovigilance database with the aim of evaluating the drug-induced mortality risk. A database containing 189 441 entries of suspected adverse reactions reported from 1 January 1995 to 31 December 2012 was explored for fatal outcomes. Potential disproportionality was estimated using the reporting odds ratio, proportional reporting ratio, and the χ-test. Two-hundred fatal outcomes were reported in patients on antipsychotics, which indicated the occurrence of disproportionality for this pharmacological class compared with any other drugs. When data were analysed by antipsychotic subclass, disproportionality was found only for atypical but not for typical antipsychotics. When individually analysed by active substances and routes, only a few substances were found to show disproportionality. The disproportionality encountered in this study compared with the mortality associated with other drugs suggests that the active substances under study may be associated with a mortality risk higher than what is assumed currently. Also, it suggests that atypical antipsychotics are likely to have a mortality risk higher than the risk of typical antipsychotics. The disproportionality found for zuclopentixol, in both oral and depot formulations, can be considered to be a drug surveillance signal.

Atypical Fracture of the Sternum After Long-Term Alendronate Plus Cholecalciferol Treatment: A Case Report.

A 55-year-old woman developed an atraumatic sternum fracture during treatment with alendronate for osteoporosis. The woman received alendronate 70 mg in combination with cholecalciferol 5600 IU once weekly, as well as nonsteroidal anti-inflammatory drugs. After 4 years of treatment, following a dorsal flexion with no direct thoracic trauma, the patient suffered a fracture of the sternum, with an X-ray revealing sternal body fracture. This fracture was seen to be transverse, noncomminuted and without displacement. Magnetic resonance imaging was carried out to rule out the presence of either a pathological fracture or a fracture resulting from osteoporotic fragility, and showed a triple sternal fracture involving the body, as well as the upper and lower manubrium of the sternum. This fracture presented the features of an atypical femur fracture, except for the location. The alendronate and cholecalciferol combination was discontinued and denosumab was prescribed. After the withdrawal of alendronate, the patient showed clinical improvement, with a decrease in pain, and is currently having routine checkups. The causality algorithm of the Spanish Pharmacovigilance System shows a score of 5, indicating a possible relationship between the patient's sternum fracture and her use of the suspect drug (Naranjo scale 6 = probable).

[Diagnosis of allergic asthma in allergy and pneumology outpatient clinics]. / Diagnóstico de asma alérgica en consultas de alergología y neumología.

OBJECTIVES: To estimate the prevalence of diagnosis of allergic asthma in patients with persistent asthma attending allergy or pneumology outpatient clinics and to describe the clinical management of asthma in these patients. METHODS: Systematic random sampling was used to retrospectively include 382 patients aged between 12 and 65 years old with a diagnosis of persistent asthma (according to GINA criteria) who had attended allergy or pneumology outpatient clinics during the previous year. Allergic asthma was defined as the presence of sensitization to any common allergen according to the results of specific IgE determinations and/or skin tests. Data on the treatment of asthma were gathered. RESULTS: Allergy studies were performed in 99.5% of the patients attending allergy centers and in 76.5% of those attending pneumology centers. A diagnosis of allergic asthma was made in 90.6% (95% CI: 86.5-94.7) and 46.1% (95% CI: 39.0-53.2), respectively. The prevalence of allergic asthma was highest in young male patients with less severe asthma. According to the GINA criteria, 14.1% of patients from allergy centres and 23.0% of those from pneumology centers were classified as having severe persistent asthma. Twenty-four percent of patients attending allergy clinics and 5.7% of those attending pneumology centers received bronchodilator treatment exclusively. CONCLUSIONS: Diagnosis of allergic asthma was much higher in allergy clinics than in pneumology centres. Although some of this difference may be due to more frequent performance of allergy studies in allergy clinics, the most probable explanation lies in the differences observed in the profiles of patients attending the two types of center.

Guillain-Barré syndrome and influenza vaccines: current evidence / Síndrome de Guillain-Barré y vacuna antigripal: evidencia actual

PURPUSE: Guillain-Barré Syndrome (GBS) as a consequence of influenza vaccination is a relevant topic, yet to be clarified, which raises concern both amongst health care personnel and the general population. Every study and pharmacovigilance system point to need of further research and the importance of continuous monitoring of safety regarding influenza vaccines. The aim of the present study is to investigate the publication of new data since the realisation of our meta-analysis of GBS and influenza vaccines (published in 2015). METHODS: A systematic revision of PubMed, Embase, and Web of Knowledge (WOS) databases has been carried out. These report observational studies assessing GBS risk after the administration of influenza vaccines from May 2014 up to July 20th, 2017. RESULTS: The research yielded 107 articles. Only three studies met established inclusion criteria and referred to an estimation GBS risk after some influenza vaccine. Two studies investigated GBS risk by the pandemic A/H1N1 vaccine, while only one looked into season vaccines. CONCLUSIONS: The present systematic review, conducted after the publication of our previous meta-analysis, seems to confirm its previous results. Therefore, GBS should be considered an infrequent adverse effect of influenza vaccination, which should not negatively influence its acceptance. Unfortunately, very few of the systematically surveyed studies meeting inclusion criteria. This fact sharply contrasts with the current consensus as to the need of continuously monitoring the safety of influenza vaccines

INTRODUCCIÓN: El síndrome de Guillain-Barré (GBS) después de la administración de la vacuna frente a la gripe es un tema actual que sigue causando preocupación tanto en el personal sanitario como en la población y que permanece sin esclarecer. El objetivo del presente trabajo es investigar la publicación de nuevos datos desde la realización de nuestro metaanálisis sobre el GBS y las vacunas frente a la gripe (publicado en 2015). MÉTODOS: Se ha realizado una revisión sistemática en las bases de datos PubMed, Embase y Web of Science (WOS) de estudios observacionales que evaluarán el riesgo de GBS después de la administración de vacunas influenza, desde mayo de 2014 hasta el 20 de julio de 2017. RESULTADOS: El resultado de las búsquedas fue de 107 artículos. Finalmente, solo 3 estudios cumplían con los criterios de inclusión establecidos y referían una estimación del riesgo de GBS después de alguna de las vacunas antigripales. Dos estudios investigaron el riesgo de GBS con la vacuna pandémica A/H1N1 y un estudio investigó las vacunas estacionales. CONCLUSIONES: Esta revisión sistemática parece confirmar los hallazgos obtenidos en nuestro metaanálisis. El SGB se podría considerar como un posible efecto adverso poco frecuente de las vacuna antigripales, lo cual no debería afectar negativamente en su aceptación. Desafortunadamente, en nuestra revisión sistemática, hemos encontrado muy pocos estudios que cumplieran los criterios de inclusión, este hecho resulta llamativo ya que el consenso actual señala la necesidad de una monitorización continua sobre la seguridad de las vacunas antigripales

Progesterone autoimmune dermatitis with positive autologous serum skin test result.

BACKGROUND: Progesterone autoimmune dermatitis is a rare disease attributable to hypersensitivity to endogenous progesterone and characterized by cyclic dermatologic manifestations at the end of the luteal phase that disappear some days after menses. CASE: A 35-year-old woman experienced cyclic premenstrual urticaria and angioedema occurring from 4 days before to 5 days after menses. The diagnosis of progesterone autoimmune dermatitis was made by a progesterone-positive skin test. Autologous serum skin test, using sera from estrogenic and luteal phases, also elicited a positive response. The patient became pregnant with near-clearance of the urticaria. CONCLUSION: Skin tests with progesterone and autologous serum, which are easy to perform, convenient, and inexpensive, are highly useful for establishing the diagnosis of progesterone autoimmune dermatitis and ruling out other skin disorders.

Diagnóstico de asma alérgica en consultas de alergología y neumología / Diagnosis of allergic asthma in allergy and pneumology outpatient clinics

Objetivo: Estimar la prevalencia del diagnóstico de asma alérgica en pacientes con asma persistente que acuden a consultas de alergología y neumología y describir el tratamiento clínico de estos pacientes. Métodos: Se incluyó aleatoria y retrospectivamente a 382 pacientes (12-65 años de edad) con diagnóstico de asma persistente (criterios GINA) que acudieron a las consultas de neumología y alergología. Se definió asma alérgica como la presencia de sensibilización a alérgenos comunes en pruebas cutáneas y/o determinaciones de inmunoglobulina (Ig) E específica. Se recogió también información sobre el tratamiento recibido para el asma. Resultados: Se realizaron estudios alergológicos en el 99,5 y el 76,5% de los pacientes que acudieron a las consultas de alergología y neumología, respectivamente. Se estableció el diagnóstico de asma alérgica en el 90,6 (intervalo de confianza [IC] del 95%, 86,5-94,7) y el 46,1% (IC del 95%, 39,0-53,2) de los éstos, respectivamente. La prevalencia de diagnóstico de asma alérgica fue mayor entre los pacientes más jóvenes, los varones y los menos graves. El 14,1% de los pacientes de alergología y el 23,0% de neumología presentaban asma persistente grave. Un 24,0% de los pacientes de alergología y un 5,7% de los de neumología se trataban exclusivamente con broncodilatadores. Conclusiones: El diagnóstico de asma alérgica fue muy superior en las consultas de alergología que en las consultas de neumología. Parte de las diferencias pueden ser debidas a una mayor realización de estudios alérgicos en las consultas de alergología, aunque la mayor diferencia probablemente sea debida a los diferentes perfiles de los pacientes que llegan a cada una de estas consultas especializadas

Objectives: To estimate the prevalence of diagnosis of allergic asthma in patients with persistent asthma attending allergy or pneumology outpatient clinics and to describe the clinical management of asthma in these patients. Methods: Systematic random sampling was used to retrospectively include 382 patients aged between 12 and 65 years old with a diagnosis of persistent asthma (according to GINA criteria) who had attended allergy or pneumology outpatient clinics during the previous year. Allergic asthma was defined as the presence of sensitization to any common allergen according to the results of specific IgE determinations and/or skin tests. Data on the treatment of asthma were gathered. Results: Allergy studies were performed in 99.5% of the patients attending allergy centers and in 76.5% of those attending pneumology centers. A diagnosis of allergic asthma was made in 90.6% (95% CI: 86.5-94.7) and 46.1% (95% CI: 39.0-53.2), respectively. The prevalence of allergic asthma was highest in young male patients with less severe asthma. According to the GINA criteria, 14.1% of patients from allergy centres and 23.0% of those from pneumology centers were classified as having severe persistent asthma. Twenty-four percent of patients attending allergy clinics and 5.7% of those attending pneumology centers received bronchodilator treatment exclusively. Conclusions: Diagnosis of allergic asthma was much higher in allergy clinics than in pneumology centres. Although some of this difference may be due to more frequent performance of allergy studies in allergy clinics, the most probable explanation lies in the differences observed in the profiles of patients attending the two types of center

Urticaria crónica: cambiando de siglo / Chronic urticaria at the down of the millennium

No disponible

Hepatitis colestásica por ticlopidina / Cholestatic hepatitis by ticlopidin

No disponible

Ginecomastia asociada al uso concomitante de cisaprida y lansoprazol / Gynecomastia associated to simultaneous administration of cisapride and lansoprazole

No disponible