The U.S. Food and Drug Administration (FDA) is investigating the possible risks of using codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for serious side effects, including slowed or difficult breathing. We are evaluating all available information and will also consult with external experts by convening an advisory…
FDA Drug Safety Communication: FDA reporting permanent skin color changes associated with use of Daytrana patch (methylphenidate transdermal system) for treating ADHD
The U.S. Food and Drug Administration (FDA) is warning that permanent loss of skin color may occur with use of the Daytrana patch (methylphenidate transdermal system) for Attention Deficit Hyperactivity Disorder (ADHD). FDA added a new warning to the drug label to describe this skin condition, which is known as chemical leukoderma. Patients or their…
Comunicado de la FDA sobre la seguridad de los medicamentos: FDA aprueba los cambios en la etiqueta para el medicamento anticonvulsivo Potiga (ezogabine) que describen el riesgo de anormalidades de la retina, pérdida potencial de la visión y decoloración de la piel
En base a las revisiones de informes adicionales de seguridad de pacientes tratados con el medicamento anticonvulsivo Potiga (erzogabine), la Administración de Alimentos y Medicamentos de Estados Unidos (FDA, por sus siglas en inglés) ha determinado que los riesgos potenciales de pérdida de visión debido a cambios en la pigmentación de la retina y decoloración…
FDA Drug Safety Communication: FDA determines 2013 labeling adequate to manage risk of retinal abnormalities, potential vision loss, and skin discoloration with anti-seizure drug Potiga (ezogabine); requires additional study
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…