Comunicado de la FDA sobre la seguridad de los medicamentos: Recomendaciones modificadas para observación cardiovascular y uso del medicamento Gilenya (fingolimod) para la esclerosis múltiple

Esta actualización se hace a manera de seguimiento al Comunicado de la FDA sobre la seguridad de los medicamentos: Examen de seguridad sobre una muerte reportada tras la primera dosis del medicamento Gilenya (fingolimod) para la esclerosis múltiple (en inglés) el 20/12/2011. Anuncio de seguridadResumen de datos  Anuncio de seguridad El lunes, 14 de mayo…

Requesting Speakers from CDRH

The following explains the process for requesting speakers from the Center for Devices and Radiological Health (CDRH) to participate in meetings, conferences, and workshops which are being sponsored by outside organizations. Where to Send Requests: By Email: [email protected] By Fax: 301-847-8142 Or Mail to:FDA/CDRH/OCERAttn: CDRH Speaker Liaison10993 New Hampshire Ave, WO66 RM 4321Silver Spring, MD 20993…

Comunicado de la FDA sobre la seguridad de los medicamentos: Informe actualizado sobre la seguridad del medicamento Revlimid (lenalidomida) para el cáncer y el riesgo de nuevos tipos de neoplasias (nuevos tipos de cáncer)

Este informe actualizado se hace en seguimiento al Comunicado de la FDA sobre la seguridad de los medicamentos: Estudio de seguridad en curso de Revlimid (lenalidomida) y el posible aumento en el riesgo de nuevas neoplasias (en inglés) del 8/4/2011. Anuncio de seguridadInformación adicional para pacientesInformación adicional para profesionales de la saludResumen de datos  Anuncio…

FDA Drug Safety Communication: Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod)

This update is in follow-up to the FDA Drug Safety Communication: Safety review of a reported death after the first dose of multiple sclerosis drug Gilenya (fingolimod) on 12/20/2011. Safety AnnouncementData Summary Safety Announcement [05-14-2012] The U.S. Food and Drug Administration (FDA) has completed its evaluation of a report of a patient who died after…

Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject: Recall

  [Posted 05/14/2012] AUDIENCE: Risk Manager, Consumer ISSUE: Hospira, Inc. notified healthcare professionals of a recall of one lot of Hydromorphone Hydrochloride Injection 1 MG/ML, due to reports of a single Carpuject containing more than the 1 mL labeled fill volume. Opioid pain medications such as Hydromorphone have life-threatening consequences if overdosed, including respiratory depression…

FDA Safety Communication: Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients

Date Issued: May 10, 2012 Audience: People with multiple sclerosis (MS), their families and caregivers; Neurologists; Interventionalists (Radiologists, Vascular Surgeons and Neurosurgeons); Clinical Researchers; other MS health care providers; and Institutional Review Boards (IRBs). Medical Specialty: Neurology, Interventional Radiology, Vascular Surgery. Purpose: The FDA is alerting people with MS to the risks of serious injuries…

Pediatric X-ray Imaging

Description Benefits/Risks FDA’s Role and Activities FDA Initiatives in Radiation Protection of Pediatric Patients Medical Community and Industry Activities Information for Patients and Parents Information for Health Care Providers Principles of Radiation Protection Resources for Radiation Protection of Pediatric Patients Regulations and Guidelines Pertaining to Imaging Facilities and Personnel Information for Industry Reporting Problems to…

Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

Like all medical procedures, computed tomography (CT), fluoroscopy, and nuclear medicine imaging exams present both benefits and risks. These types of imaging procedures have led to improvements in the diagnosis and treatment of numerous medical conditions. At the same time, these types of exams expose patients to ionizing radiation, which may elevate a person’s lifetime…