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Fda (Photo credit: Wikipedia) Olmesartan: Drug Safety Communication – FDA Review Finds Cardiovascular Risks for Diabetics Not Conclusive
Includes: Benicar, Benicar HCT, Azor, Tribenzor, and Generics
AUDIENCE: Cardiology, Pharmacy, Family Practice, Endocrinology
ISSUE: FDA has completed its safety review and has found no clear evidence of increased cardiovascular risks associated with use of the blood pressure medication olmesartan in diabetic patients (see previous alerts linked below). FDA believes the benefits of olmesartan in patients with high blood pressure continue to outweigh the potential risks.
BACKGROUND: FDA safety review was prompted by the results of the ROADMAP trial. The ROADMAP (Randomized Olmesartan and Diabetes Microalbuminuria Prevention) clinical trial examined the effects of olmesartan in patients with type 2 diabetes, to see whether olmesartan could delay kidney damage. There was an unexpected finding of increased risk of cardiovascular death in the olmesartan group compared to the group taking a placebo, or sugar pill. However, the risk of non-fatal heart attack was lower in the olmesartan-treated patients. To evaluate these findings, FDA reviewed additional studies, including a large study in Medicare patients.
Tag: FDA
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 section of product labeling. Further postmarketing review of exenatide identified additional cases of acute pancreatitis associated with use of the drug. The product labeling has been updated to include information about acute pancreatitis in the Precautions section of the label, and information for healthcare professionals has been posted on FDA’s Web site.1 This article, based on the review of 30 reports of acute pancreatitis, describes the postmarketing data that prompted the revision to product labeling and provides recommendations to healthcare professionals regarding this serious adverse event.
Exenatide, the first-in-class incretin mimetic, is a glucagon-like peptide-1 (GLP-1) analogue that stimulates insulin release from pancreatic beta-cells in a glucose-dependent manner, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying.1 Exenatide was approved by FDA on April 28, 2005, and is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione, but have not achieved adequate glycemic control.1 Exenatide is administered by subcutaneous (SC) injection, initially as a 5 microgram (mcg) dose before the morning and evening meals, which can be increased to 10 mcg twice daily injections after 1 month of therapy. Commonly reported side effects of exenatide include nausea, vomiting, diarrhea, indigestion, and upper abdominal discomfort.
Exenatide was originally identified in the saliva of the poisonous Gila monster lizard. Pancreatitis has been reported with envenomation with Gila monster saliva due to overstimulation of the pancreas.2
From April 28, 2005, to December 31, 2006, FDA received 30 domestic reports of acute pancreatitis in patients who received exenatide treatment. Nineteen (63%) patients were female. The median age of patients described in the case reports was 60 years (range: 43-72 years).
The daily dose of exenatide was reported in 25 (83%) cases and ranged from 10-20 mcg. The median time to onset of symptoms of acute pancreatitis from the start of exenatide therapy was 34 days (range: 4-300 days). A dose-response relationship was observed in six patients who reported the onset or worsening of symptoms associated with acute pancreatitis soon after the dose of exenatide was increased from 5 mcg twice daily to 10 mcg twice daily.
Serum amylase, reported in 17 (57%) cases, ranged from 40-1,845 IU/L (normal range: 30-170 IU/L). The median serum amylase value was 384 IU/L. Serum lipase, reported in 25 (83%) cases, ranged from 62-16,970 (normal range: 7-60 IU/L). The median serum lipase value was 545 IU/L. The diagnosis of acute pancreatitis was confirmed by CT scan or ultrasound in 11 (37%) cases.
In 21 of the 30 cases (70%), the patients were hospitalized. There were no fatalities and no cases describing a hemorrhagic or necrotizing pancreatitis event. However, five patients developed serious complications, including dehydration and renal failure associated with dehydration (2), suspected ileus (2), ascites (1), and phlegmon (1) (these events are not mutually exclusive). Twenty-two patients improved after exenatide therapy was discontinued, and 15 reports described the event as resolved at the time of the report.
Twenty-seven cases (90%) reported one or more possible contributory factors, including concomitant use of medications that list pancreatitis among reported adverse events in product labeling, or confounding conditions such as obesity, gallstones, severe hypertriglyceridemia, and alcohol use. Twenty-two cases reported a positive dechallenge once the drug was discontinued; three of these cases reported recurrence of various symptoms (e.g., nausea and vomiting, abdominal pain) at re-initiation of exenatide. These findings suggested a strong temporal association between exenatide and acute pancreatitis.
Two cases reported to AERS that suggest a role for exenatide in the development of acute pancreatitis are summarized in Box 1. The first case is described in the medical literature.3 These cases were selected based on the temporal relationship between initiation of exenatide treatment or dose escalation and onset of symptoms associated with acute pancreatitis and the level of detail provided by the case reporter.
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Box 1 Case 1 A 69-year-old obese man with a 15-year history of type 2 diabetes was started on exenatide 5 mcg SC twice a day due to poorly controlled blood glucose (HbA1c 10.5%). With the initiation of exenatide treatment, pioglitazone and metformin were stopped. Following the first exenatide injection, the patient developed midepigastric abdominal pain radiating to the back. The pain intensified over the next few days and he was admitted to the hospital. Admission laboratory results were significant for an elevated serum amylase of 384 IU/L, serum lipase of 346 IU/L, low serum sodium of 130 mg/dL, blood glucose of 309 mg/dL, and white blood cell count of 11,000 cells/mm3. His serum creatinine, aspartate aminotransferase (AST), and alanine aminotransferase (ALT), triglycerides, serum calcium, and hemoglobin were within normal limits. CT scan of the abdomen revealed no evidence of cholelithiasis, and the presumptive diagnosis of acute pancreatitis was made. The patient was treated with intravenous fluids, pain medication, pantoprazole, and insulin. The patient’s abdominal pain resolved, his serum lipase normalized, and he fully recovered. The patient’s medical history was significant for diabetic neuropathy, retinopathy, hypertension, hyperlipidemia, coronary artery disease, gastroesoghageal reflux disease, colonic polyposis, depression, benign prostatic hypertrophy, convulsions, anxiety, stress, hypothyroidism, and rheumatoid arthritis. There was no previous history of pancreatitis, gallstones, or alcohol use. Concomitant medications included pioglitazone, metformin, Humulin NPH, rapid-acting insulin analogue, paroxetine, primidone, metoprolol, gabapentin, lovastatin, irbesartan, clopidogrel, infliximab, ezetimibe, and esomeprazole. Case 2 A 51-year-old woman with a history of type 2 diabetes was started on exenatide 5 mcg SC twice a day. The patient experienced nausea, vomiting, and loss of appetite after starting the 5 mcg dose. One month later, the dose was increased to 10 mcg twice a day. Her symptoms increased, and she subsequently developed diarrhea and upper abdominal discomfort on the 10 mcg dose. Exenatide was discontinued. She was admitted to the hospital with a diagnosis of pancreatitis. She was treated with antibiotics, a liquid diet, and intravenous fluid. Diagnostic testing revealed a normal chest x-ray, normal sonogram of the gallbladder and kidneys, and an enlarged pancreas without a mass on abdominal ultrasound and CT scan. Admission laboratory results were significant for elevated serum amylase of 1,373 IU/L and serum lipase of 1,490 IU/L. During hospitalization, serum amylase and lipase decreased to 185 IU/L and 100 IU/L, respectively, and serum AST was 38 IU/L. Nausea, vomiting, and diarrhea returned after the patient restarted exenatide therapy. At the time of the report, the pancreatitis was described as resolving, but the events of “nausea, vomiting, decreased appetite, and diarrhea were ongoing.” Her medical history included depression, hyperlipidemia, urinary tract infections, and thalassemia diagnosed in childhood. The patient denied any history of pancreatitis. Her relevant concomitant medications included metformin/rosiglitazone, glimepiride, nateglinide, fenofibrate, and atorvastatin. |
Subsequent to this review of 30 cases, additional cases of acute pancreatitis in association with exenatide use have been reported to FDA, including one case with serious complications resulting in pancreatic pseudocyst and sepsis leading to death. The cause of death was reported as metabolic acidosis from ischemic stomach, liver, and small intestines due to peripheral vascular disease.
FDA will continue to monitor AERS for reports of acute pancreatitis in association with the use of exenatide and carefully evaluate the data. Healthcare professionals are asked to report any suspected serious adverse reactions in association with exenatide therapy to the FDA MedWatch program.
FDA encourages:
- Healthcare professionals to be aware of the potential for acute pancreatitis with exenatide and be alert to the signs and symptoms of acute pancreatitis. Symptoms include persistent, severe abdominal pain that can radiate to the back and may be accompanied by nausea and vomiting. Acute pancreatitis is typically confirmed by the presence of elevated levels of serum amylase and/or lipase and characteristic findings by radiological imaging.
- Physicians to discontinue exenatide if pancreatitis is suspected. If pancreatitis is confirmed, exenatide should not be restarted unless an alternative etiology for the pancreatitis is identified.
- Exenatide-treated patients to promptly seek medical care if they experience unexplained severe abdominal pain with or without nausea and vomiting.
Relevant Web Sites
http://www.fda.gov/cder/drug/infopage/exenatide/default.htm
http://www.fda.gov/cder/drug/InfoSheets/HCP/exenatideHCP.htm
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Byetta
References
- Exenatide (Byetta) product labeling.
- Sherman M. Therapeutic Venoms. US Pharm. 2005;12:33-36.
- Denker PS, Dimarco PE. Exenatide (exendin-4)-induced pancreatitis: a case report. Diabetes Care. 2006;29(2):471.
Dolor severo con bifosfonatos
FDA is alerting healthcare professionals that severe bone, joint, or muscle pain can occur in patients taking bisphosphonate drugs such as Fosamax (alendronate sodium), Actonel (risedronate sodium), Reclast (zoledronic acid) and Boniva (ibandronate sodium). These drugs are used to treat osteoporosis and certain other diseases.
This severe, sometimes incapacitating musculoskeletal pain has occurred within days, months, or even years after starting bisphosphonates. In the most serious cases, the pain was so severe that patients could not continue their normal activities. Some patients have complete relief of symptoms after they stop taking the drug, while others have reported slow or incomplete resolution.
Note that these events are different from the acute phase response some patients experience after the first treatment with IV bisphosphonates, and occasionally after the first dose of oral bisphosphonates.
Although severe musculoskeletal pain is described in the labeling for all bisphosphonates, this association may be overlooked by practitioners because they may assume that the patient’s pain can be attributed to osteoporosis itself.
Practitioners should consider whether musculoskeletal pain in patients on bisphosphonates might be caused by the drug, and consider discontinuing it either temporarily or permanently.
Additional Information:
FDA MedWatch Safety Alert. Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa). January 7, 2007.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Bisphosphonates
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 Alerts/Recalls
» Upcoming Public Meetings
» Consumer Health Information
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NEWS
Food, Medical Product Safety Among Key FY ‘O9 FDA Budget Requests
FDA is requesting nearly $2.4 billion as part of the president’s fiscal year (FY) 2009 budget—a 5.7 percent increase over the current fiscal year budget. The budget proposal includes strategic increases to strengthen food protection, modernize drug safety, speed approval of generic drugs, and improve the safety and review of medical devices.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01789.html
Doubled Risk of Suicidal Thoughts, Behaviors Seen With Antiepileptic Use
FDA has alerted health care professionals about an increased risk of suicidal thoughts and behaviors (suicidality) in patients who take drugs called antiepileptics to treat epilepsy, bipolar disorder, migraine headaches, and other conditions. An FDA analysis of suicidality reports from placebo-controlled studies of 11 antiepileptic drugs shows that patients taking these drugs have about twice the risk of suicidal thoughts and behaviors (0.43 percent), compared with patients receiving a placebo (0.22 percent).
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01786.html
FDA Approves New Drug-Eluting Stent for Opening Clogged Heart Arteries
FDA has approved the Endeavor Zotarolimus-Eluting Coronary Stent for use in treating patients with narrowed coronary arteries. The device
is a tiny metal mesh tube coated with a small amount of a new drug, zotarolimus, developed only for use on a stent. It is crimped around a balloon and delivered to a narrowed section of a coronary artery through a long, thin catheter. When the stent is positioned, the balloon is inflated, expanding into the vessel wall where it will remain in place, acting as a mechanical scaffold to keep the artery open.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01787.html
To view an archive of recent FDA news releases, go to
To access the RSS feed of FDA news releases, go to
Los antiepilépticos aumentan riesgo de suicidio
Fuente: Medciclopedia.
Los pacientes que toman antiepilépticos tiene doble riesgo de pensamientos y comportamientos suicidas, alertó la FDA.
La agencia revisó 199 estudios clínicos controlados con placebo de 11 drogas antiepilépticas y encontró que los pacientes que toman estos medicamentos tienen un 0.43% se suicidio, comparado al 0.22% de los que tomaron placebo.
El análisis de la agencia incluye las siguientes drogas:
- Carbamacepina (Carbatrol, Equetro, Tegretol)
- Felbamato (Felbatol)
- Gabapentina (Neurontin)
- Lamotrigina (Lamictal)
- Oxcarbacepina (Trileptal)
- Pregabalina (Lyrica)
- Tiagabina (Gabitril)
- Topiramato (Topamax)
- Valproato (Depakotem, Depakene, Depacon)
- Zonisamida (Zonegran)
La agencia considera que todos los medicamentos antiepilépticos deben tener una advertencia respecto al suicidio. La agencia advierte que los médicos deben notificar a los pacientes, sus familiares y cuidadores, para que sean observados de cerca monitoreando cambios notables en el comportamiento.
Alerta de la FDA.
FDA News: Jarabes para tos y resfrio
FDA News
PARA PUBLICACIÓN INMEDIATA
La FDA entrega recomendaciones sobre el uso de productos para la tos y el resfriado de venta sin receta médica.
Estos productos no se deben usar en niños menores de 2 años; la evaluación continúa en las poblaciones de mayor edad.
La Administración de Medicamentos y Alimentos de los Estados Unidos (FDA, Food and Drug Administration) emitió hoy una advertencia de salud pública para padres y cuidadores recomendando que los productos para la tos y el resfriado de venta sin receta médica (OTC, por sus siglas en inglés) no se deben usar para tratar a bebés y niños menores de 2 años porque efectos secundarios serios y potencialmente peligrosos para la vida pueden ocurrir de tal uso. Los productos para la tos y el resfriado de venta sin receta médica incluyen descongestionantes, expectorantes, antihistamínicos y antitusivos (inhibidores de la tos) para el tratamiento del resfriado.
Se ha reportado una gran variedad de efectos adversos serios e inusuales con productos para la tos y el resfriado, entre las que se incluyen la muerte, convulsiones, frecuencia cardíaca acelerada y disminución en los niveles de conciencia.
“La FDA recomienda encarecidamente a los padres y cuidadores no usar medicamentos para la tos y el resfriado de venta sin receta médica en niños menores de 2 años”, declaró Charles Ganley, M.D., director de la Oficina de Productos de Venta sin Receta Médica de la FDA. “No
se ha demostrado que estos medicamentos, que tratan los síntomas pero no la afección subyacente, sean seguros o eficaces en niños menores de 2 años.”
El anuncio no incluye la recomendación final de la FDA acerca del uso de medicamentos para la tos y el resfriado de venta sin receta médica en niños de entre 2 y 11 años. La agencia continúa con la revisión de datos de niños de estas edades. La FDA está comprometida a hacer una revisión oportuna e integral de la seguridad de los medicamentos para la tos y el resfriado de venta sin receta médica en los niños. La agencia tiene planes para publicar sus recomendaciones sobre el uso de los productos en niños de entre 2 y 11 años tan pronto como ésta revisión esté completa.
La declaración de hoy se basa en la revisión de datos por parte de la FDA y el análisis en una reunión conjunta de los Comités Asesores de Medicamentos de Venta sin Receta Médica y de Pediatría realizada el 18 y 19 de octubre de 2007.
En espera del término de la revisión en curso de la FDA, los padres y cuidadores que elijan usar medicamentos para la tos y el resfriado de venta sin receta médica en niños de entre 2 y 11 años deben:
seguir las indicaciones sobre la dosis que aparecen en la etiqueta de cualquier medicamento de venta sin receta médica; comprender que estos medicamentos NO curarán ni reducirán la duración de un resfrío común; revisar la etiqueta de “Información del medicamento” para saber qué ingredientes activos contiene el producto, ya que muchos productos para la tos y el resfriado de venta sin receta médica contienen múltiples ingredientes activos; usar sólo las cucharas o tazas de medida que vienen con el medicamento o las que
FDA Releases Recommendations Regarding Use of Over-the-Counter…
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01778_span.html
son hechas especialmente para medir medicamentos. La FDA recomienda a cualquier persona que tenga preguntas comunicarse con un médico, farmacéutico u otro profesional de la salud para analizar la forma de tratar a un niño que tiene tos o un resfrío.
Para obtener más información y la lista completa de las recomendaciones de la FDA, visite:
Advertencia de salud pública: Nonprescription Cough and Cold Medicine Use in Children
(Uso de medicamentos para la tos y el resfriado de venta sin receta médica en niños)
http://www.fda.gov/cder/drug/advisory/cough_cold_2008.htm
Questions and Answers for Consumers
(Preguntas y respuestas para los consumidores)
Bifosfonatos asociados con dolor intenso
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Los bifosfonatos pueden causar dolor muscular severo y en algunas ocasiones incapacitante, según una alerta de la FDA. Los pacientes pueden desarrollar dolor intenso en días, meses o años de iniciado el tratamiento, algunos reportan alivio completo después de suspender el tratamiento. Aunque la información al precribir bifosfonatos ya alerta sobre dolor musculares, la advertencia puede ser malinterpretada por trabajadores de la salud.
La agencia remarca que el dolor intenso se diferencia de los síntomas que ocurren con frecuencia (fiebre, escalofrios, dolor óseo) durante las primeras dósis de bifosfonatos intravenosos o las formulaciones orales. Los síntomas iniciales, dice la FDA, se resuelven en los primeros días. Alerta de la FDA. |
La FDA aprueba una prueba rápida de infección viral respiratoria
La FDA aprobó un test de ácido nucleíco que simultáneamente busca a 12 diferentes virus respiratorios.
La prueba, que debe hacerse en secreciones de la garganta, se llama xTAG Respiratory Viral Panel y es desarrollada por Luminex Molecular Diagnostics. La FDA dijo que es la primer prueba que diferencia los subtipos H1 y H3 del virus de la influenza A. Es también la primer prueba que detecta el recién identificado metaneumovirus. Además, la preba identifica:
- influenza B;
- virus sincital respiratorio, subtipos A y B;
- parainfluenza 1, 2, y 3;
- rhinovirus;
- adenovirus.
El fabricante sostiene que juntos estos virus son causantes del 85% de las infecciones respiratorias. La FDA advierte que un resultado positivo de esta prueba no excluye otras fuentes de infección.
Alerta de la FDA
En definitiva, ahora faltan los articulos donde se hable de la relación del rinovirus con la fractura de cadera, el sarcoma de Kapossi, y la tuberculosis, o cualquier otra forma de terrorismo sanitario para que nos quede en claro la necesidad de saber que virus tenemos, aunque no se necesite tratamiento y el problema sea autolimitado.
Public Citizen Sues FDA to Force Agency to Act on Petition Seeking Stricter Antibiotic Warnings
Public Citizen Sues FDA to Force Agency to Act on Petition Seeking Stricter Antibiotic Warnings
Fuente: Public Citizen
Despite long-standing evidence that fluoroquinolone antibiotics such as CIPRO and LEVAQUIN can cause tendon ruptures, the Food and Drug Administration (FDA) has failed to increase its warnings to patients and physicians about the dangers of the medicines, Public Citizen told a federal court Thursday.
Public Citizen, the authors of WorstPills.org, sued in the U.S. District Court for the District of Columbia, asking the court to force the FDA to act upon a petition the consumer group filed with the agency 16 months ago. The FDA has failed to respond to the petition, which Public Citizen contends is a violation of the Administrative Procedure Act.
The petition. asked the agency to put a “black box” warning on fluoroquinolone antibiotics to make doctors and patients more aware of the risk of serious tendon injury before tendons actually rupture. A “black box” is the strongest type of warning the FDA can request.
The petition also urged the FDA to send a warning letter to physicians, as well as require an FDA-approved medication guide to be dispensed when prescriptions are filled.
Stronger warnings could lead to earlier intervention and prevent needless injuries by allowing doctors to switch patients to other antibiotics, according to Dr. Sidney Wolfe, editor of WorstPills.org.
“While the FDA sits idly by and ignores the problem, more people will suffer serious tendon ruptures that could have been prevented,” Wolfe said. “The current warning is buried in a long list of possible side effects and is far too easy to miss.”
From November 1997 through December 2005, the FDA received 262 reports of tendon ruptures, mainly of the Achilles tendon, 258 cases of tendinitis and 274 cases of other tendon disorders in patients using fluoroquinolone antibiotics. An additional 74 tendon ruptures have subsequently been reported to the FDA for a total of 336. Because only a small fraction of cases are typically reported to the FDA, the actual number of ruptures and other tendon injuries attributable to the antibiotic is much higher.
Medicamentos contra el catarro y la tos
Una de las revistas médicas más prestigiosas e influyentes de EEUU, ‘The New England Journal of Medicine’, ha solicitado que las autoridades retiren de forma inmediata de las farmacias las medicinas contra el catarro y la tos para niños.
La revista recordó que un comité de expertos de la Agencia de Alimentación y Medicamentos (FDA) recomendó en octubre de este año ‘una acción inmediata contra el uso de medicamentos contra el catarro y la tos’ en niños menores de seis años. A pesar de ello, el organismo no ha tomado ninguna medida.‘Creemos que deberían solicitar de forma inmediata a las compañías que retiren esos productos de las farmacias y comiencen los procedimientos legales para exigirles que lo hagan’, dijo la revista en el editorial de la última edición, dado a conocer hoy.
La revista afirma que ‘en la comunidad pediátrica, durante más de dos décadas, ha aumentado la preocupación sobre la eficacia y seguridad’ de estos medicamentos, de los que cada año se venden 95 millones de unidades.
Frente a los avisos de la comunidad médica en los últimos años, desde enero de 2000 los centros de control de intoxicaciones ‘han registrado más de 750.000 llamadas relacionadas con productos contra el catarro y la tos’, señaló la revista.
Entre otros motivos de preocupación se señalan los vínculos, en niños menores de seis años, entre descongestionantes y arritmias cardiacas y otros problemas cardiovasculares, o las relaciones entre antihistamínicos y alucinaciones.
‘Una revisión de la Agencia de Alimentación y Medicamentos (FDA) identificó 123 muertes relacionadas con el uso de tales productos en niños menores de seis años durante las pasadas décadas. Se han asociado serios efectos negativos con la sobredosis accidental’, explicó la publicación.
El texto también indica que ‘la mercadotecnia de estos preparados para niños no refleja los riesgos o la falta de evidencia de su eficacia’. Por el contrario, la publicidad ‘asegura que los preparados son seguros y efectivos y muchos declaran que los ingredientes son ‘recomendados por pediatras”.
Artículos relacionados:
Hay que demandar a las empresas farmacéuticas
“La gente está cansada de los fármacos sintéticos, que producen más efectos adversos que otra cosa”
Nuevo beta bloqueador aprobado para hipertensión
Nebivolol (Bystolic), un bloqueador selectivo de adrenoreceptores beta 1 con efectos vasodilatadores ha sido aprovado para el tratamiento de hipertensión, según anunció la FDA.En 4 estudios controlados con placebo, más de 2,000 pacientes recibieron nebivolol, y los investigadores enconraron que su eficacia era similar a la otros beta bloqueadores. En uno de los estudios, los pacientes con control inadecuado de su tensión arterial y que usaban dos antihipertensivos, redujeron sus cifras de tensión arterial al tomar nebivolol.
Algunos pacientes que recibieron nebivolol reportaron cefalea, fatiga, mareo, y diarrea.
Anuncio de la FDA.
No hay evidencia de que los IBP incrementen el riesgo de eventos cardiacos
La FDA ha concluído que el uso a largo plazo de los inhibidores de la bomba de protones (IBP) omeprazol y esomeprazol no está asociado con un riesgo incrementado de problemas cardiacos.En Agosto, la FDA había publicado un reporte preliminar que al parecer estas drogas no incrementaban el riesgo cardiaco. Ahora, después de finalizar su revisión de la evidencia, la agencia a reafirmado su postura.
FDA informed healthcare professionals of the issuance of the Agency’s follow-up communication regarding its review of safety data for the drugs omeprazole and esomeprazole that raised concerns about a potential increased risk of heart problems for patients treated with these drugs. The Agency conducted a comprehensive review of the data from two studies that were submitted to FDA. FDA continues to believe that long-term use of omeprazole or esomeprazole is not likely to be associated with an increased risk of heart problems and recommends that healthcare providers continue to prescribe and patients continue to use these products in the manner described in the labeling for the two products. See the “Update of Safety Review” for information regarding the two studies that were reviewed.
Read the complete MedWatch 2007 Safety Summary including a link to the follow-up FDA communication regarding this issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Omeprazole
Physician’s First Watch
Antibiotic, Nasal Steroid Not Effective for Treating Acute Sinusitis
Fitness Strongly Predicts Mortality Risk in the Elderly, Regardless of Adiposity
FDA: Desmopressin Increases Risk for Hyponatremia
Antibiotic, Nasal Steroid Not Effective for Treating Acute Sinusitis
Amoxicillin or budesonide, either alone or in combination, doesn’t improve symptoms of acute sinusitis, according to a randomized, double-blind trial in JAMA.
The study included some 200 patients over age 15, from 58 family practices in the U.K., who met clinical criteria for acute sinusitis (at least two of the following: unilateral or bilateral purulent nasal discharge, unilateral pain, and intranasal pus). The patients were assigned to receive the antibiotic amoxicillin, the topical nasal steroid budesonide, both, or placebos. Patients with recurrent sinusitis were excluded.
The proportion of patients with symptoms lasting 10 days or more did not differ among the four groups. Overall, 40% of patients were cured at 1 week, with no differences among groups.
An editorialist notes that certain subgroups of patients may benefit from antibiotics or topical steroids, but until such subgroups are identified, “cautious use of antibiotics in the general practice setting for patients with sinusitis is warranted.”
JAMA article (Free)
JAMA editorial (Subscription required)
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Fitness Strongly Predicts Mortality Risk in the Elderly, Regardless of Adiposity
Maintaining cardiorespiratory fitness may be at least as important as avoiding obesity in reducing mortality among the aged, researchers report in JAMA.
A cohort of some 2600 adults aged 60 or older underwent a baseline health exam and exercise testing. After a mean follow-up of 12 years, the authors write, “both fitness and BMI were strong and independent predictors of all-cause mortality,” regardless of other measures of adiposity, such as body-fat percentage. They also found that people who were fit and obese had a lower risk for all-cause death than did people who were unfit and normal weight or lean.
They conclude: “It may be possible to reduce all-cause death rates among older adults, including those who are obese, by promoting regular physical activity, such as brisk walking for 30 minutes or more on most days of the week.”
JAMA article (Free abstract; full text requires subscription)
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FDA: Desmopressin Increases Risk for Hyponatremia
The antidiuretic drug desmopressin acetate increases the risk for severe hyponatremia in some patients, the FDA said on Tuesday.
The agency has reviewed some 60 incidents of hyponatremia-related seizures linked to desmopressin. Two-thirds of the cases were in patients who had a disease or were taking drugs also associated with hyponatremia or seizures; over half were associated with the intranasal formulation.
The FDA recommends that:
- children with primary nocturnal enuresis not be given the intranasal formulation, and that physicians “should consider other options”;
- patients taking desmopressin tablets stop treatment during periods of fluid and electrolyte imbalance (e.g., fever, recurrent diarrhea or vomiting, intense exercise, or other conditions associated with increased water intake);
- all formulations be used cautiously in patients “with habitual or psychogenic polydipsia or in patients who are taking drugs that may cause them to drink more fluids, such as tricyclic antidepressants and [SSRIs].”
FDA alert (Free)
Physician's First Watch
Antibiotic, Nasal Steroid Not Effective for Treating Acute Sinusitis
Fitness Strongly Predicts Mortality Risk in the Elderly, Regardless of Adiposity
FDA: Desmopressin Increases Risk for Hyponatremia
Antibiotic, Nasal Steroid Not Effective for Treating Acute Sinusitis
Amoxicillin or budesonide, either alone or in combination, doesn’t improve symptoms of acute sinusitis, according to a randomized, double-blind trial in JAMA.
The study included some 200 patients over age 15, from 58 family practices in the U.K., who met clinical criteria for acute sinusitis (at least two of the following: unilateral or bilateral purulent nasal discharge, unilateral pain, and intranasal pus). The patients were assigned to receive the antibiotic amoxicillin, the topical nasal steroid budesonide, both, or placebos. Patients with recurrent sinusitis were excluded.
The proportion of patients with symptoms lasting 10 days or more did not differ among the four groups. Overall, 40% of patients were cured at 1 week, with no differences among groups.
An editorialist notes that certain subgroups of patients may benefit from antibiotics or topical steroids, but until such subgroups are identified, “cautious use of antibiotics in the general practice setting for patients with sinusitis is warranted.”
JAMA article (Free)
JAMA editorial (Subscription required)
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Fitness Strongly Predicts Mortality Risk in the Elderly, Regardless of Adiposity
Maintaining cardiorespiratory fitness may be at least as important as avoiding obesity in reducing mortality among the aged, researchers report in JAMA.
A cohort of some 2600 adults aged 60 or older underwent a baseline health exam and exercise testing. After a mean follow-up of 12 years, the authors write, “both fitness and BMI were strong and independent predictors of all-cause mortality,” regardless of other measures of adiposity, such as body-fat percentage. They also found that people who were fit and obese had a lower risk for all-cause death than did people who were unfit and normal weight or lean.
They conclude: “It may be possible to reduce all-cause death rates among older adults, including those who are obese, by promoting regular physical activity, such as brisk walking for 30 minutes or more on most days of the week.”
JAMA article (Free abstract; full text requires subscription)
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FDA: Desmopressin Increases Risk for Hyponatremia
The antidiuretic drug desmopressin acetate increases the risk for severe hyponatremia in some patients, the FDA said on Tuesday.
The agency has reviewed some 60 incidents of hyponatremia-related seizures linked to desmopressin. Two-thirds of the cases were in patients who had a disease or were taking drugs also associated with hyponatremia or seizures; over half were associated with the intranasal formulation.
The FDA recommends that:
- children with primary nocturnal enuresis not be given the intranasal formulation, and that physicians “should consider other options”;
- patients taking desmopressin tablets stop treatment during periods of fluid and electrolyte imbalance (e.g., fever, recurrent diarrhea or vomiting, intense exercise, or other conditions associated with increased water intake);
- all formulations be used cautiously in patients “with habitual or psychogenic polydipsia or in patients who are taking drugs that may cause them to drink more fluids, such as tricyclic antidepressants and [SSRIs].”
FDA alert (Free)
Blogs de interes: Medciclopedia
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Dieta con alto índice de glucosa eleva riesgo de diabetes Una dieta rica en alimentos con un alto índice de glucemia puede incrementar el riesgo para padecer diabetes mellitus tipo 2 en mujeres de raza negra y chinas, según un estudio en Archives of Internal Medicine. En un estudio, alrededor de 40,000 mujeres negras sin diabetes completaron cuestionarios de comidas frecuentes y fueron seguidas durante 8 años. Después del ajuste de edad e índice de masa corporal, el riesgo para DM2 se incrementaba de la misma manera que se incrementaba el índice de glucemia en los alimentos. De igual manera, el riesgo disminuía si se consumía cereal rico en fibra. Un segundo estudio que siguió 64,000 mujeres chinas por 5 años, el índice de glucemia y la ingesta de carbohidratos (particularmente arroz) se asociaron positivamente con el desarrollo de DM2. Los autores del primer estudio consideran que las mujeres negras pueden disminuir su riesgo de padecer diabetes si aumentan el consumo de fibra en su dieta diaria. Mientras tanto, el segundo estudio hace énfasis en las consecuencias en la salud pública de los resultados de su estudio, dado que el arroz y otros carbohidratos son el alimento básico en muchas culturas. |
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Aprobado Zyrtec para su venta sin receta Posted: 26 Nov 2007 04:20 PM CST La FDA aprovó que el medicamento para alergia Zyrtec (cetirizina) se venda sin receta médica para su uso tanto en niños como en adultos. Las presentaciones de tableta y tableta masticable se podrán usar para eliviar síntomas de fiebre del heno y otras alergias respiratorias, así como urticaria, en adultos y niños mayores de 6 años. El jarabe se puede utilizar para los mismos padecimiento, y su aprovación se extiende a niños mayores de 2 años. Los efectos secundarios incluyen sueño, fatiga y boca seca. Anteriormente, la FDA había aprovado la venta de Zyrtec-D sin receta en adultos y niños mayores de 12 años. Alerta de la FDA |
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La FDA reflexiona sobre advertencias psiquiátricas en medicamentos para el resfriado común Posted: 26 Nov 2007 04:14 PM CST Un reporte de la FDA recomienda añadir etiquetas de advertencia acerca de posible efectos secundarios neuropsiquiátricos en pacientes que tomen la droga para influenza oseltamivir (Tamiflu) y zanamavir (Relenza) El reporte se preparó para la reunión del Comité Asesor en Pediatría (PAC, por sus siglas en inglés) que se llevará a cabo esta semana. La FDA encontró 596 casos de eventos neuropsiquiátricos asociados con seltamivir y 115 con zanamivir. Los casos, mayormente en pacientes de 21 años de edad o menores, y más frecuente japoneses, incluyen delirio, alucinaciones, y comportamiento compulsivo, incluído el deseo de saltar. Cinco fatalidades se asociaron con el uso de oseltamivir mientras que con zanamivir no se asoció ninguna fatalidad. La agencia aclaró que no se pudo determinar si tales padecimientos fueron debido a la enfermedad o a la medicación. Sin embargo, los reportes plantean la pregunta sobre si los eventos fueron resultado de los medicamentos inhibidores de la neuroaminidasa. Parece prudente que ambos medicamentos lleven etiqutas de precacución de alucinaciones, delirio y comportamiento anormal. Glaxo y Roche, quienes son los fabricantes de los medicamentos, dijeron que las etiquetas son innecesarias, por que los eventos pudieron ser producto de los síntomas del resfriado común. Reporte de la FDA |
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Cuestionable la seguridad de medicamentos contra el asma Posted: 26 Nov 2007 04:01 PM CST Un nuevo reporte de la FDA concluye que el agonista beta 2 inhalado salmeterol (comercializado con el nombre Severent y, combinado con fluticasona, Advair) puede tener un rieso-beneficio desfavorable para el tratamiento del Asma en niños. Una revisión de eventos adversos reportados encontró 9 casos, incluyendo 5 muertes, en niños menores de 16 años en los primeros 13 meses de iniciar tratamiento con Severent. Los efectos adversos incluyen respuesta terapéutica disminuída, sobredosis, mareo y colapso circulatorio. Ninguna de ellas se presentaba sola en niños. Se recomienda un analisis más a fondo del riesgo-beneficio del uso del medicamento. Reporte de la FDA |
Public Citizen y Rosiglitazona (Avandia).
Recibido de Worst Pills, Best Pills Drug Alert
In May, a study in the New England Journal of Medicine linked the diabetes drug rosiglitazone (AVANDIA, AVANDAMET and AVANDARYL) to heart attacks and heart-related deaths. But the heart risks of this drug should not have been a surprise.
Public Citizen has long warned about the dangers of using the glitazone class of diabetes drugs, beginning with our petition to the Food and Drug Administration (FDA) in 2000 for better warnings. We have classified rosiglitazone as a Do Not Use drug for the past three years.
Since the release of the New England Journal of Medicine study, the following actions have been taken:
1/ In October, the Department of Veterans Affairs, after conducting its own review, removed rosiglitazone from its formulary (the drugs that its doctors may prescribe), concluding that, “for some patients, rosiglitazone may not afford the same margin of safety as alternative drug therapies.”
2/ On November 6, 2007, Health Canada, the Canadian equivalent of the U.S. FDA, issued broad new restrictions on the use of rosiglitazone. In Canada, rosiglitazone is now no longer approved either as a single treatment for diabetes (except for patients unable to take metformin), or for use in combination with a sulfonylurea* except when patients are unable to take metformin.
Furthermore, Health Canada warns that rosiglitazone should not be used in any of these situations: in patients taking insulin, in combination with metformin and a sulfonylurea drug, or in patients diagnosed with any degree of heart failure, either past or current, even that which is very mild (NYHA Classes I, II, III, or IV).
Health Canada advises patients to talk to their doctors about the benefits and risks of continuing therapy, especially those with heart disease or at a high risk for a heart attack or heart failure.
3/ Shortly after the Canadian warning, on November 14, the FDA modified its black box warning for rosiglitazone concerning heart attacks, but in a most confusing fashion: it cites four analyses. One of the four is a meta-analysis of 42 studies which showed an increased risk of heart attacks; the results of the three others “have not confirmed or excluded this risk,” according to the FDA. This is inaccurate and provides no useful guidance to patients or their physicians.
The FDA needs to immediately publish an alert similar to that of Health Canada to warn U.S. citizens who are at increased risk from heart attacks and heart failure not to take rosiglitazone. Until then, Health Canada remains the sole source of this vital information.
We continue to label Avandia as a Do Not Use drug.
Learn more:
Read our July 2007 article about the risk of heart problems with
rosiglitazone: https://www.worstpills.org/member/newsletter.cfm?n_id=538
See the new Health Canada restrictions on rosiglitazone here:
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/2007/avandia_pc-cp_4_e.html.
*Examples of sulfonylurea drugs are glyburide, glimepiride, and
tolbutamide. Ask your doctor if you are taking these or any other drugs
in this class.
En Argentina:
| AVANDIA • GlaxoSmithKline |
Rosiglitazona mas metformina:
| AVANDAMET • GlaxoSmithKline |
Fuente: Alfabeta
Aprobacion de la FDA de Risperidona para el tratamiento de la esquizofrenia y trastorno bipolar en niños y adolescentes
El empleo de Risperdal para el tratamiento de la esquizofrenia y el trastorno bipolar en niños y adolescentes ha sido aprobado por la FDA, la agencia estadounidense del medicamento. Según este organismo, la reciente aprobación permitirá que el fármaco, que se compone básicamente de risperidona, se indique en pacientes esquizofrénicos de entre 13 y 17 años y en jóvenes con trastorno bipolar de edades comprendidas entre los 10 y los 17 años
Utilizado habitualmente para tratar distintos trastornos psiquiátricos en adultos y que había sido aprobado para la irritabilidad en jóvenes con autismo, este medicamento es el primero que obtiene una autorización específica para el tratamiento de la esquizofrenia en niños. La eficacia del fármaco en el tratamiento de la esquizofrenia y el trastorno bipolar ha quedado demostrada en tres estudios que valoraron sus efectos a corto plazo, según informó la FDA.
Dos trabajos, cuya duración varió entre las seis y las ocho semanas, evaluaron los beneficios de Risperdal en pacientes jóvenes con esquizofrenia. Sus resultados mostraron que los individuos que habían sido tratados con el fármaco presentaban, en general, menos síntomas como delirios y alucinaciones. Por su parte, la efectividad de Risperdal en el tratamiento del trastorno bipolar infantil se evaluó a través de un trabajo de tres semanas de duración. Sus conclusiones también muestran una disminución de los síntomas en los pacientes que recibieron el medicamento, según el informe de la FDA.
Si bien hasta este momento la agencia estadounidense no había aprobado ningún fármaco para el tratamiento de la esquizofrenia en niños y adolescentes, era cuestión de tiempo el empleo de fármacos como Risperdal en niños y adolescentes con problemas psiquiátricos. Este medicamento se aprobó por primera vez en 1993 para el tratamiento de la esquizofrenia en adultos. La FDA recuerda que este fármaco puede tener algunos efectos secundarios como somnolencia, ansiedad, náuseas, mareo, boca seca, temblores o sarpullidos, entre otros.
Suspension de comercializacion de aprotinina
La FDA anuncio que ante un pedido de la agencia, Bayer Pharmaceuticals Corp. accedio a la suspension de la comercializacion de aprotinina, a la espera de una evaluacion mas detallada de los resultados preliminares del ensayo
clinico canadiense BART, llevado a cabo por el Ottawa Health Research Institute, que sugerian un aumento de la mortalidad del 50% en el grupo de pacientes tratados con aprotinina al mes de tratamiento, comparado con los grupos control con acido tranexamico o acido aminocaproico.
el informe esta disponible en
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01738.html
por su parte la agencia española , AGEMED realizo un anuncio similar
NOTA INFORMATIVA SUSPENSIÓN CAUTELAR DE LA COMERCIALIZACIÓN DE TRASYLOL®
(APROTININA)
Ref: 2007/15 5 de noviembre de 2007
disponible en http://www.agemed.es/actividad/alertas/usoHumano/seguridad/aprotinina-nov07.htm
ya el 25 de octubre la FDA habia comunicado la suspension del Estudio BART debido al aumento de riesgo de muerte con el grupo de aprotinina.
En el Boletin Farmacos Volumen 10, numero 1, de enero de 2007 pueden consultar los antecedentes.
Aprotinina: Riesgo renal y cardiovascular, ocultacion de datos por parte de Bayer y modificación del etiquetado
http://www.boletinfarmacos.org/012007/advertencias_sobre_medicamentos_cambios.asp
Martin Cañas
Base de datos sobre suplementos dieteticos
The National Library of Medicine has released a new resource focused on dietary supplements. The Dietary Supplements Labels Database http://dietarysupplements.nlm.nih.gov includes information from the labels of over 2,000 brands of dietary supplements in the marketplace, including vitamins, minerals, herbs or other botanicals, amino acids, and other specialty supplements.
The database is designed to help both the general public and health care providers find information about ingredients in brand-name products, including name, form, active and inactive ingredients, amount of active ingredient/unit, manufacturer/distributor information, suggested dose, label claims, warnings, percentage of daily value, and further label information.
Links to other NLM resources, such as MedlinePlus and PubMed, are provided for additional health information. In addition, links to related Fact Sheets from the U.S. Food and Drug Administration ( FDA), Office of Dietary Supplements (ODS), National Center for Complementary and Alternative Medicine (NCCAM ), and the National Cancer Institute (NCI) are also available.
Atencion Primaria 