Based on reviews of additional safety reports from patients treated with the anti-seizure drug Potiga (ezogabine), the U.S. Food and Drug Administration (FDA) has determined that the potential risks of vision loss due to pigment changes in the retina and of skin discoloration can be adequately managed by following the current recommendations in the Potiga…
Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA advierte sobre la confusión en la dosis y los errores en la medicación con el antibiótico Zerbaxa (ceftolozano y tazobactam)
La Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) les advierte a los profesionales de la salud sobre el riesgo de errores en las dosis del antibiótico Zerbaxa (ceftolozano y tazobactam) debido a la confusión acerca de la concentración del medicamento expuesta en el etiquetado del frasco y…
FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood
The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. We are continuing to investigate this safety issue and will determine whether changes are…
Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA refuerza las advertencias y cambia las instrucciones de prescripción para reducir el riesgo de sufrir reacciones alérgicas graves con el medicamento para la anemia Feraheme (ferumoxitol)
La Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) está reforzando la advertencia ya existente de que pueden darse reacciones alérgicas graves y potencialmente mortales con el medicamento para la anemia Feraheme (ferumoxitol). Hemos cambiado las instrucciones de prescripción y aprobado un Recuadro de advertencia, que es el tipo de advertencia más…
FDA Drug Safety Communication: FDA warns of serious slowing of the heart rate when antiarrhythmic drug amiodarone is used with hepatitis C treatments containing sofosbuvir Harvoni or Sovaldi in combination with another Direct Acting Antiviral drug
The U.S. Food and Drug Administration (FDA) is warning that serious slowing of the heart rate can occur when the antiarrhythmic drug amiodarone is taken together with either the hepatitis C drug Harvoni (ledipasvir/sofosbuvir) or with Sovaldi (sofosbuvir) taken in combination with another direct acting antiviral for the treatment of hepatitis C infection. We are…
FDA Drug Safety Communication: FDA strengthens warnings and changes prescribing instructions to decrease the risk of serious allergic reactions with anemia drug Feraheme (ferumoxytol)
The U.S. Food and Drug Administration (FDA) is strengthening an existing warning that serious, potentially fatal allergic reactions can occur with the anemia drug Feraheme (ferumoxytol). We have changed the prescribing instructions and approved a Boxed Warning, FDA’s strongest type of warning, regarding these serious risks. Also added is a new Contraindication, a strong recommendation…
FDA Drug Safety Communication: FDA warns of serious slowing of the heart rate when antiarrhythmic drug amiodarone is used with hepatitis C treatments containing sofosbuvir (Harvoni) or Sovaldi in combination with another Direct Acting Antiviral drug
The U.S. Food and Drug Administration (FDA) is warning that serious slowing of the heart rate can occur when the antiarrhythmic drug amiodarone is taken together with either the hepatitis C drug Harvoni (ledipasvir/sofosbuvir) or with Sovaldi (sofosbuvir) taken in combination with another direct acting antiviral for the treatment of hepatitis C infection. We are…
Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA advierte de una reducción grave de la frecuencia cardiaca cuando se usa el medicamento antiarrítmico amiodarona junto con tratamientos contra la hepatitis C que contienen sofosbuvir (Harvoni o Sovaldi), en combinación con otro fármaco antivírico de acción directa
La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) advierte que puede darse una reducción grave de la frecuencia cardiaca cuando el medicamento antiarrítmico amiodarona se toma junto con el fármaco contra la hepatitis C Harvoni (ledipasvir/sofosbuvir) o con Sovaldi (sofosbuvir), en combinación con otro antivírico de acción…
FDA Drug Safety Communication: FDA warns of serious slowing of the heart rate when antiarrhythmic drug amiodarone is used with hepatitis C treatments containing sofosbuvir (Harvoni or Sovaldi) in combination with another Direct Acting Antiviral drug
The U.S. Food and Drug Administration (FDA) is warning that serious slowing of the heart rate can occur when the antiarrhythmic drug amiodarone is taken together with either the hepatitis C drug Harvoni (ledipasvir/sofosbuvir) or with Sovaldi (sofosbuvir) taken in combination with another direct acting antiviral for the treatment of hepatitis C infection. We are…
FDA Drug Safety Communication: FDA review of study sheds light on two deaths associated with the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate)
The U.S. Food and Drug Administration (FDA) has concluded a review of a study undertaken to determine the cause of elevated levels of the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate) in two patients who died. The study results were inconclusive. We are unable to exclude the possibility that the deaths were caused by rapid,…