FDA Drug Safety Communication: Ongoing Safety Review of Stalevo and possible increased cardiovascular risk

Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary Safety Announcement [08-20-2010] The U.S. Food and Drug Administration (FDA) is evaluating clinical trial data that suggest patients taking Stalevo (a combination of carbidopa/levodopa and entacapone) may be at an increased risk for cardiovascular events (heart attack, stroke, and cardiovascular death) compared to those taking…

FDA Drug Safety Communication: FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved

The U.S. Food and Drug Administration (FDA) is cautioning that differences in dosing regimens between the two oral formulations of the antifungal Noxafil (posaconazole) have resulted in dosing errors.  To help prevent additional medication errors, the drug labels were revised to indicate that the two oral formulations cannot be directly substituted for each other but…

La FDA actualiza las etiquetas de los inhibidores del SGLT2 para la diabetes a fin de incluir advertencias sobre concentraciones de ácido demasiado altas en la sangre e infecciones graves del tracto urinario

[12/4/2015] Una reciente evaluación de seguridad realizada por la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) ha llevado a la adición de advertencias a las etiquetas de una clase específica de medicamentos para la diabetes de tipo 2, llamados inhibidores del cotransportador de sodio-glucosa tipo 2 (SGLT2,…

FDA Drug Safety Communication: FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections

[12-4-2015] A U.S. Food and Drug Administration (FDA) safety review has resulted in adding warnings to the labels of a specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors about the risks of too much acid in the blood and of serious urinary tract infections.  Both conditions can result in hospitalization. Patients…

La FDA informa de casos poco comunes de hipotiroidismo en bebés que recibieron medios de contraste yodados para espectroscopía médica

La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) notifica que se ha informado de casos poco comunes de hipotiroidismo en bebés tras el uso de medios de contraste que contienen yodo, también llamados “tinción de contraste”, para tomar radiografías y realizar otros procedimientos de espectroscopía médica. En…

FDA Drug Safety Communication: FDA advises of rare cases of underactive thyroid in infants given iodine-containing contrast agents for medical imaging

The U.S. Food and Drug Administration (FDA) is advising that rare cases of underactive thyroid have been reported in infants following the use of contrast media containing iodine, also called “contrast dye,” for X-rays and other medical imaging procedures. In all of the reported cases, the infants were either premature or had other serious underlying…

FDA Drug Safety Communication: FDA review finds long-term treatment with blood-thinning medicine Plavix (clopidogrel) does not change risk of death

The Dual Antiplatelet Therapy (DAPT)1 trial was a randomized, double-blind, placebo-controlled trial that compared antiplatelet treatment for 30 months vs. 12 months following percutaneous coronary intervention and placement of a drug-eluting stent. After stent placement, patients received 12 months of dual antiplatelet therapy consisting of aspirin plus either clopidogrel (Plavix) or prasugrel (Effient) and then…