FDA Drug Safety Communication: FDA warns that prescribing of Nizoral (ketoconazole) oral tablets for unapproved uses including skin and nail infections continues; linked to patient death

[05-19-2016] The U.S. Food and Drug Administration (FDA) is warning health care professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections. Use of this medication carries the risk of serious liver damage, adrenal gland problems, and harmful interactions with other medicines that outweigh its benefit in treating…

FDA Drug Safety Communication: Interim clinical trial results find increased risk of leg and foot amputations, mostly affecting the toes, with the diabetes medicine canagliflozin (Invokana, Invokamet); FDA to investigate

The U.S. Food and Drug Administration (FDA) is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet). We have not determined whether canagliflozin increases the risk of leg and…

Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA aconseja restringir el uso de antibióticos a base de fluoroquinolonas para ciertas infecciones sin complicaciones; advierte sobre efectos secundarios discapacitantes que pueden presentarse juntos

La Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) advierte que los efectos secundarios graves relacionados con los medicamentos antibacterianos a base de fluoroquinolonas por lo general superan los beneficios para los pacientes con sinusitis, bronquitis e infecciones del tracto urinario sin complicaciones para los que existen otras opciones de tratamiento. En…

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…