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…
FDA Drug Safety Communication: Aseptic meningitis associated with use of Lamictal (lamotrigine)
Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary Safety Announcement [08-12-2010] The U.S. Food and Drug Administration (FDA) is informing the public that Lamictal (lamotrigine)†, a medication commonly used for seizures in children two years and older, and bipolar disorder in adults, can cause aseptic meningitis. FDA is revising the Warnings and…
FDA Drug Safety Communication: Update: Follow up to the Public Health Alert about Changes to the Heparin Sodium USP Monograph
Safety Announcement Additional Information for Patients Additional Information for Healthcare Professionals Data Summary Table to Distinguish Between “New” and “Old” Heparin Safety Announcement [04-07-2010] Laboratory studies performed at the request of the U.S. Food and Drug Administration (FDA) have shown that Heparin Sodium, USP (heparin) made under the new United States Pharmacopeia (USP) Monograph (“new…
FDA Drug Safety Communication: New Boxed Warning on severe liver injury with propylthiouracil
Safety Announcement Additional Information for Patients Additional Information for Healthcare Professionals Data Summary Safety Announcement [04-21-2010] The United States Food and Drug Administration (FDA) has added a Boxed Warning to the label for propylthiouracil, a drug used to treat hyperthyroidism (overactive thyroid), to include information about reports of severe liver injury and acute liver failure,…