[ 05-02-2016 ] The U.S. Food and Administration (FDA) has approved a brand name change for the antidepressant Brintellix (vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from name confusion with the blood-thinning medicine Brilinta (ticagrelor). The new brand name of the drug will be Trintellix, and it is expected to be…
FDA Drug Safety Communication: FDA to review study examining use of oral fluconazole (Diflucan) in pregnancy
The U.S. Food and Drug Administration (FDA) is evaluating the results of a Danish study1 that conclude there is a possible increased risk of miscarriage with the use of oral fluconazole (Diflucan) for yeast infections. We are also reviewing additional data and will communicate our final conclusions and recommendations when our review is complete. Health…
La FDA actualiza las advertencias relativas al uso de la metformina, una medicina para la diabetes, en ciertos pacientes con una función renal deteriorada
[4/8/2016] La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) está exigiendo cambios al etiquetado con respecto a las recomendaciones para las medicinas para la diabetes que contienen metformina, a fin de ampliar el uso de este fármaco en ciertos pacientes con una función renal deteriorada. La etiqueta…
La FDA agrega advertencias acerca del riesgo de insuficiencia cardiaca a las etiquetas de los medicamentos para diabetes tipo 2 que contengan saxagliptina y alogliptina
El estudio SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) fue un estudio grande, prospectivo, multicéntrico, aleatorizado, doble ciego controlado por placebo que se realizó en 16,492 pacientes con diabetes mellitus tipo 2, con enfermedad cardiovascular establecida o en riesgo más alto de enfermedad cardiovascular. El seguimiento de los pacientes se…
FDA Drug Safety Communication: Avandia (rosiglitazone) labels now contain updated information about cardiovascular risks and use in certain patients
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FDA Drug Safety Communication: FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function
The U.S. Food and Drug Administration (FDA) is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use in certain patients with reduced kidney function. The current labeling strongly recommends against use of metformin in some patients whose kidneys do not work normally. We were asked1,2 to review numerous medical…
FDA Drug Safety Communication: FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and alogliptin
[ 4-5-2016 ] A U.S. Food and Drug Administration (FDA) safety review has found that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. Heart failure can result in the heart not being able to pump enough blood to…
La FDA advierte de varios problemas de seguridad con los analgésicos opiáceos y exige cambios a la etiqueta
La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) está advirtiendo acerca de varios problemas de seguridad con toda la clase de los analgésicos opiáceos. Estos riesgos de seguridad incluyen interacciones potencialmente nocivas con muchos otros medicamentos, problemas con las glándulas suprarrenales y disminución de los niveles de…
FDA Drug Safety Communication: Eosinophilic pneumonia associated with the use of Cubicin (daptomycin)
Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary Safety Announcement [07-29-2010] The U.S. Food and Drug Administration (FDA) is informing patients and healthcare professionals about the potential for developing eosinophilic pneumonia during treatment with Cubicin (daptomycin), an intravenous antibacterial drug. Cubicin was first approved in September 2003 to treat serious skin…