RESUMEN
Among 8 countries included in the report of ANSM, France is second behind Spain, when defined daily doses (DDD) are considered. Few studies, recent and based on representative samples of population, investigated the use of benzodiazepines in other countries and data are limited to compare France and other countries. In most countries, the use of benzodiazepines increases with age and is more frequent in women than in men. Variations of benzodiazepines use that were observed in other countries are similar to those observed in France, with a slight decrease but persistent high levels of use. In most countries, the long-term use of benzodiazepines is stable over time even though simple use decreases.
Asunto(s)
Benzodiazepinas/efectos adversos , Benzodiazepinas/uso terapéutico , Comparación Transcultural , Utilización de Medicamentos/estadística & datos numéricos , Trastornos Relacionados con Sustancias/epidemiología , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Estudios Transversales , Femenino , Francia , Humanos , Masculino , Persona de Mediana Edad , Adulto JovenRESUMEN
OBJECTIVE: To assess the nature and conditions of the occurrence of adverse drug reactions (ADRs) of bromocriptine, which is used to inhibit lactation. DESIGN: Observational study. SETTING: Cases from the French pharmacovigilance database and the marketing authorisation holders. SAMPLE: Serious ADRs reported between 1994 and 2010 in association with bromocriptine used for lactation inhibition in France. METHODS: Each case was checked to confirm the bromocriptine indication, the seriousness of the ADR, the modalities of bromocriptine use, and to identify possible associated predisposing factors. MAIN OUTCOME MEASURES: Number and description of serious ADRs, with a particular focus on misuse and associated predisposing factors. RESULTS: Among 105 serious ADRs, including two fatal cases, the most frequent were cardiovascular (70.5%), neurological (14.3%), and psychiatric (8.6%) disorders. Cardiovascular disorders primarily consisted of ischaemic manifestations (n = 47): acute ischaemic stroke (n = 18, one death), myocardial infarction (n = 11, one death), and reversible postpartum cerebral angiopathy (n = 10). Misuse was identified in 52 cases (70.3%) of cardiovascular disorders, and mostly consisted of bromocriptine continuation despite the occurrence of first symptoms suggesting an ADR or the absence of a progressive titration of bromocriptine. About half of these women had cardiovascular predisposing factors, mainly tobacco smoking, overweight or obesity, or a history of hypertension or pre-eclampsia. CONCLUSIONS: This survey, together with published data, provides further evidence that serious ADRs still occur after bromocriptine use in lactation inhibition, and that most of these ADRs could have been avoided. The use of bromocriptine should therefore be limited to cases where no other options are available to inhibit lactation.
Asunto(s)
Bromocriptina/efectos adversos , Trastornos Cerebrovasculares/inducido químicamente , Agonistas de Dopamina/efectos adversos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Hipertensión/inducido químicamente , Lactancia/efectos de los fármacos , Infarto del Miocardio/inducido químicamente , Accidente Cerebrovascular/inducido químicamente , Sistemas de Registro de Reacción Adversa a Medicamentos , Bromocriptina/administración & dosificación , Causalidad , Trastornos Cerebrovasculares/epidemiología , Agonistas de Dopamina/administración & dosificación , Francia/epidemiología , Humanos , Hipertensión/epidemiología , Infarto del Miocardio/epidemiología , Farmacovigilancia , Pautas de la Práctica en Medicina , Medicamentos bajo Prescripción/efectos adversos , Accidente Cerebrovascular/epidemiologíaRESUMEN
AIM: To describe drugs targeting urethra and prostate to treat dysfunctions such LUTS related to BPH, primary bladder neck obstruction (PBNO), detrusor sphincter dyssynergia (DSD) or sphincter deficiency (SD). METHOD: Pubmed search for efficacy, mode of action and side effects for each molecule. Additional data were searched from the French regulatory agencies web sites (HAS and ANSM). RESULTS: To treat LUTS related to BPH alpha-blockers (AB) and 5-alpha reductase inhibitors (5ARIs) have a clearer efficacy than plant extract. Daily Phosphodiesterase 5 inhibitors (PDE5Is) alone or in association with AB also demonstrate efficacy in this indication. AB are an option in PBNO and DSD related to multiple sclerosis. Although Botulinum toxin A derived molecules decrease urethral pressure in patient with DSD related to spinal cord injury or multiple sclerosis, efficiency remains to be demonstrated. Duloxetine a serotonin reuptake inhibitor increases urethral sphincter pressure and reduce stress urinary incontinence in women and men. Nevertheless, moderate efficacy combine with frequent side effects lead French regulation agency to reject its agreement. CONCLUSION: Armamenterium to treat urethral dysfunctions has recently increases. Two new therapeutic classes emerge: PDE5Is to treat LUTS related to BPH and an SRIs (Duloxetine) to treat stress urinary incontinence. Efficacy and safety evaluation of all the possible associations between drugs targeting urethra and/or bladder is needed to a subtler and more efficient pharmacologic modulation of lower urinary tract dysfunction.