The U.S. Food and Drug Administration (FDA) is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. Many other products for these conditions are available that do not contain aspirin. These widely used products…
FDA Drug Safety Communication: FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse
The U.S. Food and Drug Administration (FDA) is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death. The risk of these serious heart problems, including abnormal heart rhythms,…
FDA Drug Safety Communication: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch
The U.S. Food and Drug Administration (FDA) is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine headaches. We are investigating the cause and extent of these serious side effects and will update the public with new information when our review is…
Expanded Access to Investigational Drugs for Treatment Use — Qs & As
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Charging for Investigational Drugs Under an IND — Qs & As
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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…