El riesgo de sufrir un trastorno sangu íneo grave y potencialmente mortal insta a la FDA a tomar una medida en cuanto a los productos orales de venta libre a base de benzocaína, utilizados para la dentición y el dolor de boca, y los anestésicos locales recetados
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 31, 2018 Category: Drugs & Pharmacology Source Type: news

El riesgo de sufrir un trastorno sangu í neo grave y potencialmente mortal insta a la FDA a tomar una medida en cuanto a los productos orales de venta libre a base de benzoca í na, utilizados para la dentici ó n y el dolor de boca, y los anest é sicos locales recetados
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 31, 2018 Category: Drugs & Pharmacology Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos La FDA evaluar á el riesgo potencial de defectos cong é nitos del tubo neural ocasionados por el medicamento contra el HIV dolutegravir (Juluca, Tivicay, Triumeq)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 23, 2018 Category: Drugs & Pharmacology Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos La FDA evaluar á el riesgo potencial de defectos congénitos del tubo neural ocasionados por el medicamento contra el HIV dolutegravir (Juluca, Tivicay, Triumeq)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 23, 2018 Category: Drugs & Pharmacology Source Type: news

Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics
FDA is taking safety actions regarding over-the-counter benzocaine oral drug products and prescription local anesthetics. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 22, 2018 Category: Drugs & Pharmacology Source Type: news

Enforcement Policy -- OTC Sunscreen Drug Products Marketed Without an Approved Application
Compliance (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 21, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)
The U.S. Food and Drug Administration (FDA) is alerting the public that serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir (Juluca, Tivicay, Triumeq) used to treat human immunodeficiency virus (HIV). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 18, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA advierte sobre una reacci ón grave del sistema inmunitario con el medicamento para convulsiones y enfermedades psiquiátricas lamotrigina (Lamictal)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 3, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA advierte sobre una reacci ó n grave del sistema inmunitario con el medicamento para convulsiones y enfermedades psiqui á tricas lamotrigina (Lamictal)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 3, 2018 Category: Drugs & Pharmacology Source Type: news

Clinical Trial Imaging Endpoint Process Standards Guidance for Industry
Clinical/Medical (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 26, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal)
The Food and Drug Administration (FDA) is warning that the medicine lamotrigine (Lamictal) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body ’s infection-fighting immune system. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 24, 2018 Category: Drugs & Pharmacology Source Type: news

Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic
Drug Safety (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 11, 2018 Category: Drugs & Pharmacology Source Type: news

Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling
Advertising (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 26, 2018 Category: Drugs & Pharmacology Source Type: news

Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products for Over-the-Counter Human Use (Small Entity Compliance Guide)
Over-the-Counter; Small Entity Compliance Guide (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 22, 2018 Category: Drugs & Pharmacology Source Type: news

Q8, Q9, & Q10 Questions and Answers -- Appendix: Q & As from Training Sessions (Q8, Q9, & Q10 Points to Consider)
International Council on Harmonisation - Quality (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 22, 2018 Category: Drugs & Pharmacology Source Type: news

S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
International Council on Harmonisation - Safety (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 22, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA revisa la descripci ó n de los efectos secundarios para la salud mental de los medicamentos para dejar de fumar Chantix (vareniclina) y Zyban (bupropi ó n) para reflejar las conclusiones de estudio cl í nico
FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 8, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA revisa la descripci ón de los efectos secundarios para la salud mental de los medicamentos para dejar de fumar Chantix (vareniclina) y Zyban (bupropión) para reflejar las conclusiones de estudio clínico
FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 8, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings
An FDA review found the side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) are lower than previously suspected. These risks still exist, but we believe the benefits of quitting smoking outweigh them. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 8, 2018 Category: Drugs & Pharmacology Source Type: news

La revisi ó n de la FDA no encontr ó un aumento de los riesgos cardiovasculares en el medicamento entacapona para el mal de Parkinson
[10-26-2015] Una revisi ó n de seguridad de la Administraci ó n de Alimentos y Medicamentos (FDA) no ha encontrado evidencia clara de un aumento del riesgo de ataques card í acos, accidente cerebrovascular u otros eventos cardiovasculares relacionados con el uso de entacapona para el tratamiento del mal de Parkinson. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 8, 2018 Category: Drugs & Pharmacology Source Type: news

La revisi ón de la FDA no encontró un aumento de los riesgos cardiovasculares en el medicamento entacapona para el mal de Parkinson
[10-26-2015] Una revisi ón de seguridad de la Administración de Alimentos y Medicamentos (FDA) no ha encontrado evidencia clara de un aumento del riesgo de ataques cardíacos, accidente cerebrovascular u otros eventos cardiovasculares relacionados con el uso de entacapona para el tratamiento del mal de Parkinson. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 8, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin
[06-06-2016] 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. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 8, 2018 Category: Drugs & Pharmacology Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA aconseja restringir el uso de antibi óticos a base de fluoroquinolonas para ciertas infecciones sin complicaciones; advierte sobre efectos secundarios discapacitantes que pueden presentarse juntos
[05/12/2016] La Administraci ón 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 urinar io sin complicaciones para los que existen otras opciones de tratamiento. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 8, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA agrega advertencias acerca del riesgo de insuficiencia cardiaca a las etiquetas de los medicamentos para diabetes tipo 2 que contengan saxagliptina y alogliptina
[4-5-2016] Una revisi ón de seguridad de la Administración de Alimentos y Medicamentos de EE. UU. (FDA, por sus siglas en inglés) ha llegado a la conclusión que los medicamentos para diabetes tipo 2 que contienen saxagliptina y alogliptina pueden aumentar el riesgo de insuficiencia cardiaca, en particular en paciente s que ya tienen enfermedad cardiaca o renal. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 7, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA advierte sobre casos de una infecci ón cerebral infrecuente con el medicamento para la esclerosis múltiple (EM) Gilenya (fingolimod) en dos pacientes que no habían tenido previamente exposición a medicamentos inmunodepresores
[08-04-2015] La Administraci ón de Alimentos y Medicamentos (FDA) de los Estados Unidos advierte sobre el reporte de un caso de leucoencefalopatía multifocal progresiva (LPM) definitiva y de un caso de probable LPM en pacientes que tomaban Gilenya (fingolimod) por la esclerosis múltiple (EM). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA advierte sobre casos de una infecci ó n cerebral infrecuente con el medicamento para la esclerosis m ú ltiple (EM) Gilenya (fingolimod) en dos pacientes que no hab í an tenido previamente exposici ó n a medicamentos inmunodepresores
[08-04-2015] La Administraci ó n de Alimentos y Medicamentos (FDA) de los Estados Unidos advierte sobre el reporte de un caso de leucoencefalopat í a multifocal progresiva (LPM) definitiva y de un caso de probable LPM en pacientes que tomaban Gilenya (fingolimod) por la esclerosis m ú ltiple (EM). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: FDA warns about cases of rare brain infection with MS drug Gilenya (fingolimod) in two patients with no prior exposure to immunosuppressant drugs
[07-04-2015] The U.S. Food and Drug Administration is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

LA FDA refuerza la advertencia que los medicamentos sin aspirina antinflamatorios no esteroides (AINES) puedan causar ataques cardiacos o derrames cerebrales
[7-9-2015] La Administraci ó n de Alimentos y Medicamentos de Estados Unidos (FDA) est á reforzando la advertencia existente de la etiqueta que los medicamentos sin aspirina antinflamatorios no esteroides (AINES) aumentan la probabilidad de ataque card í aco o derrame cerebral. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA est á evaluando los riesgos potenciales de usar medicinas para la tos y para la gripe que contengan codeína
[7-1-2015] La Administraci ón de Alimentos y Medicamentos (FDA) está investigando los posibles riesgos de utilizar medicamentos que contengan codeína para el tratamiento de tos y gripe en niños menores de 18 años de edad debido al potencial de sufrir efectos secundarios graves, incluyendo respiración lenta o dificultosa . La FDA está evaluando toda la información disponible y también consultará con expertos externos convocando un comité asesor para discutir estos problemas de salud. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA est á evaluando los riesgos potenciales de usar medicinas para la tos y para la gripe que contengan code í na
[7-1-2015] La Administraci ó n de Alimentos y Medicamentos (FDA) est á investigando los posibles riesgos de utilizar medicamentos que contengan code í na para el tratamiento de tos y gripe en ni ñ os menores de 18 a ñ os de edad debido al potencial de sufrir efectos secundarios graves, incluyendo respiraci ó n lenta o dificultosa. La FDA est á evaluando toda la informaci ó n disponible y tambi é n consultar á con expertos externos convocando un comit é asesor para discutir estos problemas de salud. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations
This is the Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 5, 2018 Category: Drugs & Pharmacology Source Type: news

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, p é rdida potencial de la visi ó n y decoloraci ó n de la piel
[15-06-2015] En base a las revisiones de informes adicionales de seguridad de pacientes tratados con el medicamento anticonvulsivo Potiga (erzogabine), la Administraci ó n de Alimentos y Medicamentos de Estados Unidos (FDA, por sus siglas en ingl é s) ha determinado que los riesgos potenciales de p é rdida de visi ó n debido a cambios en la pigmentaci ó n de la retina y decoloraci ó n de la piel pueden ser manejados adecuadamente siguiendo las recomendaciones actuales en la etiqueta de Potiga. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 5, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: FDA review found no increased cardiovascular risks with Parkinson ’ s disease drug entacapone
[10-26-2015] A Food and Drug Administration (FDA) safety review has found no clear evidence of an increased risk of heart attacks, stroke, or other cardiovascular events associated with the use of entacapone for the treatment of Parkinson ’ s disease. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 5, 2018 Category: Drugs & Pharmacology Source Type: news

Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations
Biopharmaceutics (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 2, 2018 Category: Drugs & Pharmacology Source Type: news

Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations
Biopharmaceutics (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 2, 2018 Category: Drugs & Pharmacology Source Type: news

Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application
Biopharmaceutics (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 2, 2018 Category: Drugs & Pharmacology Source Type: news

Bioanalytical Method Validation [Revised Final]
Biopharmaceutics (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 2, 2018 Category: Drugs & Pharmacology Source Type: news

Una revisi ón de la FDA descubre que datos adicionales respaldan la posibilidad de mayor riesgo a largo plazo del antibiótico claritromicina (Biaxin) en pacientes con cardiopatías
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 27, 2018 Category: Drugs & Pharmacology Source Type: news

Una revisi ó n de la FDA descubre que datos adicionales respaldan la posibilidad de mayor riesgo a largo plazo del antibi ó tico claritromicina (Biaxin) en pacientes con cardiopat í as
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 27, 2018 Category: Drugs & Pharmacology Source Type: news

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
[06-16-2015] 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 labeling. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 26, 2018 Category: Drugs & Pharmacology Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA actualiza la etiqueta del medicamento para dejar de fumar Chantix (vareniclina), para incluir la posible interacci ón con el alcohol, un riesgo poco común de sufrir convulsiones, y los estudios de efectos secundarios en el estado de ánimo, la conducta o el pensamiento
[3-9-2015] La Administraci ón de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) advierte que el medicamento de prescripción médica para dejar de fumar Chantix (vareniclina) puede alterar el modo en que las personas reaccionan al alcohol. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 26, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: FDA requires label warnings to prohibit sharing of multi-dose diabetes pen devices among patients
[2-25-2015] In an effort to reduce the serious risk of infection spread through sharing of multi-dose diabetes pen devices intended for single patient use only, the U.S. Food and Drug Administration (FDA) is requiring additional label warnings prohibiting sharing of these injectable medicines. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 26, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events
[9-26-2014] A U.S. Food and Drug Administration (FDA) review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug Xolair (omalizumab) than in those who were not treated with Xolair. As a result, we have added information about these potential risks to the drug label. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 26, 2018 Category: Drugs & Pharmacology Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: Estudio de la FDA de pacientes de Medicare encontr ó menor riesgo de derrame cerebral y muerte con Pradaxa (dabigatrán) en comparación con warfarina
[05-13-2014] En su estudio en curso del anticoagulante Pradaxa (dabigatr án), la Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus sigla en inglés) completó recientemente un nuevo estudio en pacientes de Medicare en el que compara Pradaxa con un anticoagulante antiguo, warfarina (Coumadin, Jantoven y genéricos), para determinar el riesgo de a ccidente isquémico o derrame causado por un coágulo, hemorragia cerebral, hemorragia gastrointestinal severa, infarto de miocardio y muerte. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 26, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin
[05-13-2014] In its ongoing review of the blood thinner Pradaxa (dabigatran), the U.S. Food and Drug Administration (FDA) recently completed a new study in Medicare patients comparing Pradaxa to an older blood thinner, warfarin, for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 26, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: FDA approves label changes for antibacterial Doribax (doripenem) describing increased risk of death for ventilator patients with pneumonia
[03-06-2014] The U.S. Food and Drug Administration (FDA) has concluded that Doribax (doripenem), an antibacterial drug that has been used to treat patients who develop pneumonia while on ventilators, carries an increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin for injection (marketed in the U.S. under the name Primaxin). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 26, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: FDA requires multiple new safety measures for leukemia drug Iclusig; company expected to resume marketing
The U.S. Food and Drug Administration (FDA) is requiring several new safety measures for the leukemia drug Iclusig (ponatinib) to address the risk of life-threatening blood clots and severe narrowing of blood vessels. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 26, 2018 Category: Drugs & Pharmacology Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: FDA requiere que se eliminen ciertas restricciones al recetar y dispensar medicamentos para la diabetes que contienen rosiglitazona
El 25 de noviembre, 2013, La Administraci ón de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) ha determinado que datos recientes sobre medicamentos que contienen rosiglitazona, como Avandia, Avandamet, Avandaryl y versiones genéricas, no indican un riesgo mayor de ataque al corazón en comparación con los med icamentos estándar metformina y sulfonilurea para la diabetes de tipo 2. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 26, 2018 Category: Drugs & Pharmacology Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: Suspensi ó n de ventas y mercadeo de Iclusig (ponatinib): Instrucciones para profesionales de la salud sobre c ó mo obtener acceso de emergencia a Iclusig para los pacientes que responden a é l
La Administraci ó n de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en ingl é s) est á dando instrucciones a los profesionales de la salud que tienen pacientes que han estado tomando Iclusig (ponatinib) y se est á n beneficiando del medicamento, sobre c ó mo posibilitar que dichos pacientes sigan tomando el medicamento. Estamos trabajando estrechamente con el fabricante de Iclusig, Ariad Pharmaceuticals (Ariad), para evitar interrupciones en el tratamiento. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 26, 2018 Category: Drugs & Pharmacology Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: Suspensi ón de ventas y mercadeo de Iclusig (ponatinib): Instrucciones para profesionales de la salud sobre cómo obtener acceso de emergencia a Iclusig para los pacientes que responden a él
La Administraci ón de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) está dando instrucciones a los profesionales de la salud que tienen pacientes que han estado tomando Iclusig (ponatinib) y se están beneficiando del medicamento, sobre cómo posibilitar que dichos pacientes sigan tom ando el medicamento. Estamos trabajando estrechamente con el fabricante de Iclusig, Ariad Pharmaceuticals (Ariad), para evitar interrupciones en el tratamiento. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 26, 2018 Category: Drugs & Pharmacology Source Type: news