Los resultados provisionales de un ensayo clínico indican que hay un riesgo mayor de sufrir amputaciones de pies y piernas, afectando sobre todo los dedos de los pies, con el uso de la medicina para la diabetes canagliflozina (Invokana, Invokamet); la FDA investigará

Los profesionales de la salud deben acatar las recomendaciones de la etiqueta de información farmacológica de la canagliflozina. Esté atento a la presencia de los indicios y síntomas antes descritos en los pacientes, y aconséjeles acudir al médico de experimentarlos. La canagliflozina es un medicamento de prescripción médica que se emplea en conjunción con una…

FDA Drug Safety Communication: FDA warns that prescribing of 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: 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…