Safety Announcement [01-31-2014]Â The U.S. Food and Drug Administration (FDA) is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of…
Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA advierte de posibles efectos adversos por exceder la dosis recomendada de productos de venta libre que contienen fosfato de sodio para el tratamiento del estreñimiento
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FDA Drug Safety Communication: FDA requires multiple new safety measures for leukemia drug Iclusig; company expected to resume marketing
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FDA Drug Safety Communication: FDA warns of rare risk of long-lasting erections in males taking methylphenidate ADHD medications and has approved label changes
Safety Announcement [12-17-2013] Â The U.S. Food and Drug Administration (FDA) is warning that methylphenidate products, one type of stimulant drug used to treat attention deficit hyperactivity disorder (ADHD), may in rare instances cause prolonged and sometimes painful erections known as priapism. FDA continues to monitor the safety of drugs after they are approved, and, based…
Comunicado de la FDA sobre la seguridad de los medicamentos: FDA advierte de graves reacciones de la piel con el medicamento anticonvulsivo Onfi (clobazam) y ha aprobado cambios a la etiqueta
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FDA Drug Safety Communication: FDA warns of serious skin reactions with the anti-seizure drug Onfi (clobazam) and has approved label changes
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Comunicado de la FDA sobre la seguridad de los medicamentos: FDA requiere que se eliminen ciertas restricciones al recetar y dispensar medicamentos para la diabetes que contienen rosiglitazona
Resumen de datos Metaanálisis previos (análisis extensos y combinados) de pruebas y estudios de observación habÃan indicado un riesgo más elevado de ataques al corazón y otros sucesos cardiovasculares adversos con el tratamiento de rosiglitazona. Como resultado, la FDA requirió una REMS que restringÃa el uso del medicamento. Debido a las limitaciones de dichos datos,…
FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines
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Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA advierte de riesgo poco común pero grave de ataque al corazón y muerte con los medicamentos Lexiscan (regadenoson) y Adenoscan (adenosina) para la prueba nuclear de esfuerzo cardÃaco
Referencias1. Shah S, Parra D, Rosenstein RS. Acute myocardial infarction during regadenoson myocardial perfusion imaging. Pharmacotherapy 2013;33:90-5. 2. Hsi DH, Marreddy R, Moshiyakhov M, Luft U. Regadenoson induced acute ST-segment elevation myocardial infarction and multivessel coronary thrombosis. J Nucl Cardiol 2013;20:481-4.3. Iskandrian AE, Bateman TM, Belardinelli L, Blackburn B, Cerqueira MD, Hendel RC, et al….
Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA solicita cambios a la etiqueta y empaque de uso único para productos antisépticos tópicos de venta sin receta médica para disminuir el riesgo de infección
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