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FDA Drug Safety Communication: FDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix (vortioxetine) and antiplatelet Brilinta (ticagrelor)
The U.S. Food and Drug Administration is warning health care professionals and patients that reports of confusion between the antidepressant Brintellix and anti-blood clotting medication Brilinta have resulted in the wrong medication being prescribed or dispensed. We have determined that the main reason for the confusion between these two medications is the similarity of their…
FDA Drug Safety Communication: FDA evaluating the risk of brain deposits with repeated use of gadolinium-based contrast agents for magnetic resonance imaging (MRI)
The U.S. Food and Drug Administration (FDA) is investigating the risk of brain deposits following repeated use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). MRIs help detect abnormalities of body organs, blood vessels, and other tissues. Recent publications in the medical literature have reported that deposits of GBCAs (See Table 1) remain in the…
La FDA advierte sobre una seria condición pulmonar en niños y recién nacidos tratados con Proglycem (diazóxido)
La Administración de Alimentos y Medicamentos (FDA) está alertando sobre una seria condición pulmonar denominada hipertensión pulmonar, la cual es una alta presión en los vasos sanguíneos que van a los pulmones y reportada en niños y recién nacidos tratados con Proglycem (diazóxido) para el control de la glucemia. En todos los casos la hipertensión…
Approval History, Letters, Reviews, and Related Documents
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LA FDA refuerza la advertencia que los medicamentos sin aspirina antinflamatorios no esteroides (AINES) puedan causar ataques cardiacos o derrames cerebrales
La Administración de Alimentos y Medicamentos de Estados Unidos (FDA) está reforzando la advertencia existente de la etiqueta que los medicamentos sin aspirina antinflamatorios no esteroides (AINES) aumentan la probabilidad de ataque cardíaco o derrame cerebral. Basados en nuestra revisión integral de nueva información de seguridad estamos solicitando actualizaciones a las etiquetas de información farmacológica…
FDA Drug Safety Communication: FDA warns about a serious lung condition in infants and newborns treated with Proglycem (diazoxide)
The U.S. Food and Drug Administration (FDA) is warning that a serious lung condition called pulmonary hypertension, which is high pressure in the blood vessels leading to the lungs, has been reported in infants and newborns treated with Proglycem (diazoxide) for low blood sugar. In all cases, the pulmonary hypertension resolved or improved after Proglycem…
FDA Drug Safety Communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes
The U.S. Food and Drug Administration (FDA) is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Based on our comprehensive review of new safety information, we are requiring updates to the drug labels of all prescription NSAIDs. As is the case with current…
La FDA está evaluando los riesgos potenciales de usar medicinas para la tos y para la gripe que contengan codeína
La Administración de Alimentos y Medicamentos (FDA) está investigando los posibles riesgos de utilizar medicamentos que contengan codeína para el tratamiento de tos y gripe en niños menores de 18 años de edad debido al potencial de sufrir efectos secundarios graves, incluyendo respiración lenta o dificultosa. La FDA está evaluando toda la información disponible y…
FDA Drug Safety Communication: FDA evaluating the potential risks of using codeine cough-and-cold medicines in children
The U.S. Food and Drug Administration (FDA) is investigating the possible risks of using codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for serious side effects, including slowed or difficult breathing. We are evaluating all available information and will also consult with external experts by convening an advisory…