FDA Drug Safety Communication: FDA approves label changes for anti-seizure drug Potiga (ezogabine) describing risk of retinal abnormalities, potential vision loss, and skin discoloration

This is an update to the FDA Drug Safety Communication: Anti-seizure drug Potiga (ezogabine) linked to retinal abnormalities and blue skin discoloration issued on 4/26/2013. Safety Announcement [10-31-2013] The U.S. Food and Drug Administration (FDA) has approved changes to the drug label of the anti-seizure drug Potiga (ezogabine), underscoring risks of abnormalities to the retina…

FDA Drug Safety Communication: FDA asks manufacturer of the leukemia drug Iclusig (ponatinib) to suspend marketing and sales

This update is in follow-up to the FDA Drug Safety Communication: FDA investigating leukemia drug Iclusig (ponatinib) after increased reports of serious blood clots in arteries and veins issued on October 11, 2013. Safety Announcement [10-31-2013] The U.S. Food and Drug Administration (FDA) has asked the manufacturer of the leukemia chemotherapy drug Iclusig (ponatinib) to…

FDA Drug Safety Communication: FDA investigating leukemia drug Iclusig (ponatinib) after increased reports of serious blood clots in arteries and veins

Safety Announcement [10-11-2013]  The U.S. Food and Drug Administration (FDA) is investigating an increasing frequency of reports of serious and life-threatening blood clots and severe narrowing of blood vessels (arteries and veins) of patients taking the leukemia chemotherapy drug Iclusig (ponatinib).   Health care professionals should consider for each patient, whether the benefits of Iclusig…

Comunicado de la FDA sobre la seguridad de los medicamentos: Recuadro con advertencia y nuevas recomendaciones para disminuir el riesgo de reactivación de la hepatitis B con los medicamentos Arzerra (ofatumumab) y Rituxan (rituximab), que combaten el cáncer y suprimen el sistema inmunitario

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Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA advierte del aumento del riesgo de muerte con antibiótico Tygacil intravenoso (tigeciclina) y aprueba nuevo Recuadro con advertencia

Esta actualización se hace a manera de seguimiento al Comunicado de la FDA sobre la seguridad del medicamento: Mayor riesgo de muerte con Tygacil (tigeciclina) en comparación con otros antibióticos usados para el tratamiento de infecciones similares emitido el 1º de septiembre del 2010 (información en inglés). Anuncio de seguridad El 27 de septiembre, 2013,…