Category Archives: FDA

FDA sets draft rules for biotech drug copies


Image via Wikipedia Via: Linkedin By Deena Beasley Thu Feb 9, 2012 4:46pm EST (Reuters) – The Food and Drug Administration’s long-awaited guidelines for the sale of lower-cost versions of biotechnology drugs leave open the possibility that some products might … Continue reading

Posted in Amgen, Biogen Idec, Biotechnology, Brian Abrahams, Congressional Budget Office, FDA, Food and Drug Administration, Wells Fargo | Leave a comment

Where The Boys Are: Merck, Gardasil And HPV


Pharmalot by Ed Silverman In the midst of ongoing controversy over HPV vaccines, the Advisory Committee on Immunization Practices, which advises the US Centers for Disease Control and Prevention, voted unanimously to recommend routine use of Merck’s Gardasil in boys as … Continue reading

Posted in boys, CDC, FDA, Gardasil, HPV vaccine | Leave a comment

FDA Says Chantix Benefits Outweigh The Risks or were you expeting another end ?


Ed Silverman in Pharmalot After reviewing the results of two epidemiological studies that compared the controversial Chantix smoking-cessation pill with NicoDerm patches, the FDA has decided that the benefits of the Pfizer pill continue to outweigh the risks. The decision … Continue reading

Posted in FDA, Food and Drug Administration, Health, NicoDerm, Pfizer, Smoking cessation, Tobacco control movement, Varenicline | Leave a comment

Medical Device Innovation — Is “Better” Good Enough?


Image via Wikipedia Source: NEJMLast year, the United States spent $95 billion on medical devices, nearly half of the $200 billion spent on devices worldwide.1 Our investment in devices has yielded impressive gains in length and quality of life from … Continue reading

Posted in FDA, Food Drug Administration, Institute of Medicine, Joint replacement, Medical device, Surgery, Uncategorized, United States | Leave a comment

OBJECIONES EN RELACION CON AMBAS VACUNAS DISPONIBLES CONTRA EL VIRUS DEL PAPILOMA HUMANO


Image via Wikipedia OBJECIONES EN RELACION CON AMBAS VACUNAS DISPONIBLES CONTRA EL VIRUS DEL PAPILOMA HUMANO(especial para SIIC © Derechos reservados) Se presenta un análisis del diseño, evaluación, aplicación y seguimiento de las 2 vacunas disponibles contra el HPV llevado … Continue reading

Posted in Argentina, Cervical cancer, European Medicines Agency, FDA, Food and Drug Administration, HPV, Human papillomavirus, Sexually transmitted disease | Leave a comment

FDA Panel, Bayer Birth Control Pills & Blood Clots


By Ed Silverman in Pharmalot Nearly six months after a pair of studies found that women taking birth control pills containing a hormone called drospirenone are more likely to develop blood clots than those who take an older oral contraceptive, … Continue reading

Posted in anticonceptivos, drospirenone, drugs, Ed Silverman, FDA, panel meeting, Pharmalot, reproductive health | Leave a comment

Hodgin’s Lymphoma And A High-Priced Drug


Hodgin’s Lymphoma And A High-Priced Drug Ed Silverman When is a drug overpriced? The issue has come up repeatedly as various biologics treating cancer and assorted chronic conditions carry price tags in the tens of thousands of dollars. The debate … Continue reading

Posted in drugs, FDA, Hodking, overpprize, Pharmalot, prize | Leave a comment

Reevaluating Studies: A CRO & A Coincidence?


Published 1 agosto, 2011 por Ed Silverman, via Pharmalot Last week, the FDA announced that any clinical tests conducted between April 2005 and June 2010 by a contract research organization called Cetero Research may have to be reevaluated because two FDA inspections and an outside audit found … Continue reading

Posted in CRO, FDA, MSD, Pharmalot, research | Leave a comment

An Avastin Recommendation & Conflicts Of Interest


 Bevacizumab = Avastin Earlier this month, the National Comprehensive Cancer Network, a non-profit group of oncologists whose guidance is closely followed by leading treatment centers, voted overwhelmingly in favor of maintaining its recommendation that Avastin should be used to treat … Continue reading

Posted in avastin, Big Pharma, breast, Cancer, FDA, mama, NCCN, Pharmalot, Roche | Leave a comment

HiRes 90K Cochlear Implant Device: Recall – Malfunction


HiRes 90K Cochlear Implant Device: Recall – Malfunction [Posted 11/27/2010] AUDIENCE: Audiology, Patients ISSUE: Advanced Bionics (AB) announced that it will voluntarily recall its HiRes 90K cochlear implant device and is retrieving all unimplanted devices in distribution. This action is … Continue reading

Posted in Advanced Bionics, Adverse event, Cochlear implant, FDA, Patient | Leave a comment

Interaccion entre Clopidogrel y Omeprazol


FDA MEDWATCH: La FDA informa hoy sobre la interacción entre Clopidogrel y Omeprazol. Nuevos datos informan que cuando los mismos son tomados en conjunto la efectividad del Clopidogrel se ve reducida. Aquellos pacientes con riesgo coronario o accidente cerebrovascular, que … Continue reading

Posted in clopidogrel, FDA, Interacciones medicamentosas, MedWatch, omeprazol | Leave a comment

Efectos adversos del Tamiflu


Roche Laboratories has alerted healthcare professionals about neuropsychiatric events that have occurred in influenza patients taking Tamiflu (oseltamivir phosphate). Tamiflu is used to treat or prevent the flu in patients 1 year and older. The company’s letter says that there … Continue reading

Posted in Efectos Adversos, FDA, oseltamivir, tamiflu | Leave a comment

Efectos adversos del Tamiflu


Roche Laboratories has alerted healthcare professionals about neuropsychiatric events that have occurred in influenza patients taking Tamiflu (oseltamivir phosphate). Tamiflu is used to treat or prevent the flu in patients 1 year and older. The company’s letter says that there … Continue reading

Posted in Efectos Adversos, FDA, oseltamivir, tamiflu | Leave a comment

Comite de seguridad de la FDA


Ciprian Jauca, de Therapeutics Initiative, nos da una buena noticia:el Dr. Sidney Wolfe, editor en jefe de WorstPills.org y co-fundador del Grupo de Investigación en Salud “Public Citizen”, ha sido nombrado para un mandato de cuatro años en el Comité … Continue reading

Posted in FDA, Medicamentos, Public Citizen, seguridad, Sidney Wolfe | Leave a comment

Revisa la FDA retiro de fármacos contra el asma por sus efectos


■ Pide retirar tratamientos con agonistas LABA en menores de 18 años y de Serevent y Foradil en pacientes de todas las edades ■ La semana próxima consultarán a un panel de expertos Reuters Washington, 5 de diciembre. Los reguladores … Continue reading

Posted in Asma, Efectos Adversos, FDA, LABA, Medicamentos, Noticias | Leave a comment

Revisa la FDA retiro de fármacos contra el asma por sus efectos


■ Pide retirar tratamientos con agonistas LABA en menores de 18 años y de Serevent y Foradil en pacientes de todas las edades ■ La semana próxima consultarán a un panel de expertos Reuters Washington, 5 de diciembre. Los reguladores … Continue reading

Posted in Asma, Efectos Adversos, FDA, LABA, Medicamentos, Noticias | Leave a comment

FDA y seguridad en medicamentos


Ahora tanto consumidores como profesionales de salud pueden acceder desde una sola pagina de la FDA (Agencia de Alimentos y Medicamentos de los EE.UU.) a una amplia variedad de información sobre seguridad de medicamentos de venta bajo receta. La página … Continue reading

Posted in FDA, Medicamentos, seguridad, web | Leave a comment

FDA y seguridad en medicamentos


Ahora tanto consumidores como profesionales de salud pueden acceder desde una sola pagina de la FDA (Agencia de Alimentos y Medicamentos de los EE.UU.) a una amplia variedad de información sobre seguridad de medicamentos de venta bajo receta. La página … Continue reading

Posted in FDA, Medicamentos, seguridad, web | Leave a comment

Medwatch: bifosfonatos y fibrilacion auricular,


Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D)Etidronate (Didronel)Ibandronate (Boniva)Pamidronate (Aredia)Risedronate (Actonel, Actonel W/Calcium)Tiludronate (Skelid)Zoledronic acid (Reclast, Zometa) En Argentina se pueden ver los nombres comerciales desde la pagina de Alfabeta Audience: Geriatricians, gynecologists, orthopedic surgeons, other healthcare professionals FDA … Continue reading

Posted in bifosfonatos, Efectos Adversos, FDA, fibrilacion auricular, Medicamentos | Leave a comment

Medwatch: bifosfonatos y fibrilacion auricular,


Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D)Etidronate (Didronel)Ibandronate (Boniva)Pamidronate (Aredia)Risedronate (Actonel, Actonel W/Calcium)Tiludronate (Skelid)Zoledronic acid (Reclast, Zometa) En Argentina se pueden ver los nombres comerciales desde la pagina de Alfabeta Audience: Geriatricians, gynecologists, orthopedic surgeons, other healthcare professionals FDA … Continue reading

Posted in bifosfonatos, Efectos Adversos, FDA, fibrilacion auricular, Medicamentos | Leave a comment

Efalizumab y riesgos adversos


Como ya publique algo parecido el año pasado, le pido a los abogados de Serono que esta vez se ahorren el trabajo de mandar cartas documentos intimandome a bajar este post. Aunque aquel tambien tenia las referencias. Si el problema … Continue reading

Posted in efalizumab, Efectos Adversos, FDA, infeccion, leucoencefalopatia, raptiva, sepsis, Serono | Leave a comment

Efalizumab y riesgos adversos


Como ya publique algo parecido el año pasado, le pido a los abogados de Serono que esta vez se ahorren el trabajo de mandar cartas documentos intimandome a bajar este post. Aunque aquel tambien tenia las referencias. Si el problema … Continue reading

Posted in efalizumab, Efectos Adversos, FDA, infeccion, leucoencefalopatia, raptiva, sepsis, Serono | Leave a comment

Medicamentos para la tos y el resfrio: reacciones adversas graves y recomendaciones de uso


Editado por Boletín Fármacos En octubre de 2007 la FDA sostuvo una reunión de comité asesor que terminó en la recomendación de prohibir la utilización medicamentos para el resfriado en niños menores de dos años. Poco tiempo antes los fabricantes … Continue reading

Posted in antihistaminicos, Boletin de farmacos, descongestivos, Efectos Adversos, expectoreantes, FDA, Medicamentos, Resfrio | Leave a comment

Medicamentos para la tos y el resfrio: reacciones adversas graves y recomendaciones de uso


Editado por Boletín Fármacos En octubre de 2007 la FDA sostuvo una reunión de comité asesor que terminó en la recomendación de prohibir la utilización medicamentos para el resfriado en niños menores de dos años. Poco tiempo antes los fabricantes … Continue reading

Posted in antihistaminicos, Boletin de farmacos, descongestivos, Efectos Adversos, expectoreantes, FDA, Medicamentos, Resfrio | Leave a comment

Efectos adversos: erlotinib e insuficiencia hepatica


Tarceva (erlotinib) Tablets Audience: Oncological healthcare professionals OSI and Genentech notified healthcare professionals that cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment. Patients with hepatic … Continue reading

Posted in Efectos Adversos, erlonitib, FDA, insuficiencia hepatica, Medicamentos, MedWatch, tarceva | Leave a comment

Efectos adversos: erlotinib e insuficiencia hepatica


Tarceva (erlotinib) Tablets Audience: Oncological healthcare professionals OSI and Genentech notified healthcare professionals that cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment. Patients with hepatic … Continue reading

Posted in Efectos Adversos, erlonitib, FDA, insuficiencia hepatica, Medicamentos, MedWatch, tarceva | Leave a comment

Rituximab: efectos neurologicos


Se ha identificado una especie de leucoencefalopatía multifocal progresiva fatal en pacientes tomando rituximab (Rituxan) para atritis reumatoide, según reporta la FDA. La infección por virus JC anticipando a la leucoencefalopatía fué diagnósticada 18 meses depués de la última toma de rituximab. El … Continue reading

Posted in Efectos Adversos, FDA, Medicamentos, MedWatch, Neurologia, rituximab | Leave a comment

Rituximab: efectos neurologicos


Se ha identificado una especie de leucoencefalopatía multifocal progresiva fatal en pacientes tomando rituximab (Rituxan) para atritis reumatoide, según reporta la FDA. La infección por virus JC anticipando a la leucoencefalopatía fué diagnósticada 18 meses depués de la última toma de rituximab. El … Continue reading

Posted in Efectos Adversos, FDA, Medicamentos, MedWatch, Neurologia, rituximab | Leave a comment

Exenatide (marketed as BYETTA): pancreatitis aguda


Exenatide (marketed as BYETTA): Acute PancreatitisFDA has been monitoring cases of acute pancreatitis in its postmarketing review of adverse event reports associated with the use of exenatide. Spontaneous adverse event reports of acute pancreatitis were described in the Adverse Reactions … Continue reading

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Novedades de la FDA


»  News     — Food, Medical Product Safety Among Key FY ‘O9 FDA Budget Requests     — Doubled Risk of Suicidal Thoughts, Behaviors Seen With Antiepileptic Use     — FDA Approves New Drug-Eluting Stent for Opening Clogged Heart Arteries    »  Safety … Continue reading

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