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…
FDA Drug Safety Communication: FDA review found no increased cardiovascular risks with Parkinson’s disease drug entacapone
A Food and Drug Administration (FDA) safety review has found no clear evidence of an increased risk of heart attacks, stroke, or other cardiovascular events associated with the use of entacapone for the treatment of Parkinson’s disease. As a result, our recommendations for using Comtan (entacapone) and Stalevo (a combination of entacapone, carbidopa, and levodopa)…
FDA Drug Safety Communication: FDA requires drug interaction studies with potassium-lowering drug Kayexalate (sodium polystyrene sulfonate)
The U.S. Food and Drug Administration (FDA) is requiring the Kayexalate manufacturer to conduct studies to investigate Kayexalate’s potential to bind to other medications administered by mouth – drug interactions that could affect how well the other medications work. Kayexalate (sodium polystyrene sulfonate) and generic brands Kionex and SPS are used to treat hyperkalemia, a…
La FDA advierte sobre la confusión en la dosis y errores en la medicación con el antibiótico Avycaz (ceftazidima y avibactam)
La Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) de los Estados Unidos advierte a los profesionales de la salud acerca del riesgo de errores en la dosis con el antibiótico intravenoso Avycaz (ceftazidima y avibactam), debido a la confusión acerca de la potencia del medicamento que se exhibe en las etiquetas…
La FDA está evaluando los riesgos del uso del medicamento para el dolor tramadol en niños de 17 años de edad y menos
La Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) de los Estados Unidos está investigando el uso del medicamento para el dolor tramadol en niños de 17 años de edad y menos, a causa de un raro pero grave riesgo de dificultad respiratoria o respiración lenta. Este riesgo puede aumentar en los…
FDA Drug Safety Communication: FDA cautions about dose confusion and medication error with antibacterial drug Avycaz (ceftazidime and avibactam)
The U.S. Food and Drug Administration (FDA) is warning health care professionals about the risk for dosing errors with the intravenous antibacterial drug Avycaz (ceftazidime and avibactam) due to confusion about the drug strength displayed on the vial and carton labels. Avycaz was initially approved with the vial and carton labels displaying the individual strengths…
FDA Drug Safety Communication: FDA evaluating the risks of using the pain medicine tramadol in children aged 17 and younger
The U.S. Food and Drug Administration (FDA) is investigating the use of the pain medicine tramadol in children aged 17 years and younger, because of the rare but serious risk of slowed or difficult breathing. This risk may be increased in children treated with tramadol for pain after surgery to remove their tonsils and/or adenoids….
La FDA modifica el monitoreo de la neutropenia asociada con clozapina, un medicamento para la esquizofrenia; aprueba el nuevo programa REMS compartido para todos los medicamentos con clozapina
La Administración de Alimentos y Medicamentos (FDA) de Estados Unidos está realizando cambios a los requisitos para el monitoreo, prescripción, despacho y recepción de clozapina, un medicamento para la esquizofrenia, para abordar las inquietudes de seguridad continuas y el conocimiento actual sobre una condición seria de la sangre denominada neutropenia severa. La neutropenia severa es…