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Category Archives: FDA
New prescription obesity medication
Image by Getty Images via @daylife Silver Spring, Md. • A panel of medical experts voted overwhelmingly Wednesday to endorse the controversial weight-loss drug Qnexa, clearing the way for the Food and Drug Administration to approve a new prescription obesity … Continue reading
Posted in drugs, FDA, Health, medication, Medicine, obesity, Qnexa, United States
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Postmarketing Surveillance of Medical Devices — Filling in the Gaps
Image via Wikipedia Frederic S. Resnic, M.D., and Sharon-Lise T. Normand, Ph.D. February 14, 2012 (10.1056/NEJMp1114865) Failures of implantable medical devices, although rare, can carry a substantial risk of serious injury. From 2000 through 2011, more than 150 new high-risk … Continue reading
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
Gilenya (fingolimod): Drug Safety Communication – Safety Review of a Reported Death After the First Dose
Image via Wikipedia Gilenya (fingolimod): Drug Safety Communication – Safety Review of a Reported Death After the First Dose AUDIENCE: Neurology, Patients ISSUE: The FDA has received a report of a patie nt with multiple … Continue reading
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
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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
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
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
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
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
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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
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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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
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
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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
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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
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
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
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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
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GAPURMED/GAPURJovenes
