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FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together
The U.S. Food and Drug Administration is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolone should be reserved for those who do not have alternative treatment options….
FDA Drug Safety Communication: FDA warns about rare but serious skin reactions with mental health drug olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax)
The U.S. Food and Drug Administration (FDA) is warning that the antipsychotic medicine olanzapine can cause a rare but serious skin reaction that can progress to affect other parts of the body. We are adding a new warning to the drug labels for all olanzapine-containing products that describes this severe condition known as Drug Reaction…
La FDA advierte de nuevos problemas de control de impulsos en relación con el medicamento para tratar la salud mental aripiprazol (Abilify, Abilify Maintena, Aristada)
La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) advierte que se ha informado de deseos compulsivos o incontrolables de apostar, atracarse de comida, comprar y tener relaciones sexuales con el uso del fármaco antipsicótico aripiprazol (Abilify, Abilify Maintena, Aristada y sus versiones genéricas). Y se informó que…
Comunicación de la FDA sobre la seguridad de los medicamentos: La FDA aprueba el cambio de nombre para el antidepresivo Brintellix (vortioxetina) para evitar la confusión con el antiplaquetario Brilinta (ticagrelor)
[05-02-2016] La Administración de Alimentos y Medicamentos de EE. UU. (FDA) ha aprobado un cambio de nombre para el antidepresivo Brintellix (vortioxetina) con el propósito de reducir el riesgo de errores de prescripción y despacho que resultan de la confusión del nombre con el medicamento anticoagulante Brilinta (ticagrelor). El nuevo nombre de la marca del…
FDA Drug Safety Communication: FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada)
The U.S. Food and Drug Administration (FDA) is warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose…
Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment Guidance for Industry
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FDA Drug Safety Communication: FDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antiplatelet drug Brilinta (ticagrelor)
[ 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…