Celebrex es más peligroso para los pacientes con riesgo cardiovascular
• Según un estudio, los médicos sólo deberían recetarles dosis bajas de este fármaco
Actualizado martes 15/04/2008 14:40CRISTINA DE MARTOS
MADRID.- La 'superaspirina' fabricada por Pfizer, Celebrex, cuenta entre sus efectos adversos con el aumento de los problemas de corazón en las personas que la toman. Esta complicación está relacionada con la dosis administrada y es mayor en aquellos individuos con predisposición a sufrir estas patologías, según una revisión de varios estudios. El trabajo, publicado en la revista 'Circulation', fue presentado en una reunión científica del Colegio de Cardiología de Estados Unidos. Los resultados sugieren que el daño potencial de Celebrex afecta sobre todo a los pacientes más 'sensibles' a las complicaciones cardiovasculares. "Estos datos deberían dar cierta tranquilidad a la hora de recetar celecoxib [principio activo de este fármaco] a enfermos con un perfil de riesgo cardiovascular bajo", declaró Scott Solomon, investigador jefe del estudio financiado por el Instituto Nacional del Cáncer, según informa Reuters. Celebrex pertenece a la familia de los inhibidores de la COX-2, un grupo de medicamentos que desembarcó en el mercado como alternativa menos agresiva para el estómago a los demás analgésicos y antiinflamatorios. Pero pronto empezaron a aparecer los problemas que culminaron en la retirada debricado por Merck and Co.) en 2004 y de Bextra, de Pfizer. El celecoxib es la única 'superaspirina' que aún se comercializa en Estados Unidos, pero la FDA, que regula los fármacos en este país, está muy pendiente de su trayectoria. De hecho, Celebrex tiene pendiente la inclusión en su prospecto de una 'caja negra', una advertencia acerca del riesgo que su consumo supone para la salud cardiovascular. Solomon y sus colegas, algunos de los cuales han recibido en alguna ocasión financiación de Pfizer, analizaron los datos de seis ensayos con celecoxib en los que tomaron parte 7.950 pacientes. Los participantes tomaban 400 miligramos al día, 200 mg dos veces al día o dos dosis diarias de 400 mg del fármaco o de un placebo. Un análisis inicial mostró que el riesgo de muerte por patologías cardiovasculares, infarto, ictus, fallo cardiaco o formación de coágulos era mayor con la toma de dos dosis de 400 mg e inferior para la dosis única de 400 mg. Los que tomaban esta misma cantidad pero racionada en dos presentaban un peligro intermedio. Cuando los investigadores introdujeron en la ecuación el perfil de riesgo cardiovascular de los pacientes antes de iniciar este tratamiento se percataron de que aquellos con peor pronóstico previo eran los que estaban más amenazados por la aparición de estas complicaciones con dosis altas de Celebrex. Según los autores, ante un paciente con factores de riesgo cardiovascular, los médicos sólo deberían recetarles dosis bajas de este fármaco. Los resultados también deben tranquilizar a los facultativos cuando haya que tratar a alguien que no tenga esta característica, añaden. Es importante señalar que en el tratamiento de la osteoartritis se suelen emplear 200 mg diarios de celecoxib, inferior a lo estudiado. Sin embargo, para la artritis reumatoide, el dolor agudo, la dismenorrea o la adenomatosis familiar se administran dosis iguales o superiores a los 400 mg. Dudas sobre Celebrex Actualizado miércoles 10/05/2006 15:Apenas tres meses después de que, en septiembre de 2004, se retirase del mercado el moderno analgésico Vioxx debido a su riesgo coronario, un ensayo clínico sugería que otro fármaco de esa misma familia (Celebrex) podría tener problemas cardiovasculares a dosis elevadas. Desde entonces, la seguridad de los antiinflamatorios, clásicos y modernos, ha estado en el punto de mira. Lea las informaciones al respecto. Bextra Class Action Lawsuits and Claims re ready to help. If you can establish that you have been injured as a result of using Bextra, you may have the right to monetary damages including reimbursement for medical expenses, any loss of income, pain and suffering, and even punitive damages if special circumstances can be proven. Do you have a case? No matter what state you live in, click on a panel from the left or right side of this page. Pharmaceutical litigation (defect drug litigation) is governed by federal laws, so no matter where you live any of these featured LawInfo Qualified lead counsel Bextra attorneys can help you with your claim. Did you know? Two recent small studies run by Pfizer (the manufacturer of Bextra) have shown that heart bypass surgery patients taking Bextra (valdecoxib), an anti-inflammatory that serves a similar function as the recently withdrawn drug Vioxx, had a higher risk of stroke and heart attack. Recent evidence suggests that Bextra increased the risk of stroke and heart attack when it was given to very high-risk patients who had undergone coronary bypass surgery. Bextra is also being linked to Stevens Johnson Syndrome, a rare inflammatory skin disorder that can be life-threatening - up to 27 percent of those affected incur long term eye damage or vision loss, and up to 15 percent die. Bextra has only been studied in arthritis patients for up to a year. Doctors said it is too early to quantify the potential risk of Bextra or of Pfizer's other COX-2 inhibitor Celebrex as neither have tested for long enough. Pfizer said it is conducting longer term trials in arthritis patients. Serious safety concerns about the entire class of COX-2 inhibitors, including Bextra, have been raised due to the recent Vioxx recall. Have you been taking Bextra? If so, you may have a claim for a lawsuit. Contacn your area now! Additonal Bextra Information If you'd like more information regarding Bextra, including clinical studies and Food and Drug Administration (FDA) resources, please see the following Bextra links: Lawyers Ready to Take Your Bextra Case On this site, you will find law firms staffed with qualified and experiencedho specialize in cases such as these. These bextra lawyers are Lead Counsel members, which means,
among other things, that they have been practicing for several years, dedicate themselves to this type of legal issue, and are in good standing with their local bar associations. Plaintiffs in cases such as these typically seek to recover damages for medical costs, lost wages and pain and suffering. Click through on any of the firms listed on both sides of this page, and feel free to ask questions regarding your particular situation. Theatured here will handle your inquiry quickly and responsibly. If the attorney feels that further discussion and investigation is warranted, he or she will guide you through the process and provide you with quality representation when necessary. If you have suffered a personal injury as a result of taking the drug Bextra, now is the time to assert your rights. Contact one of our experiencednow to file your claim. Bextra News Section Contents Menu
[4/7/2005] The Food and Drug Administration (FDA) has issued supplemental request letters to sponsors of all non-steroidal anti-inflammatory drugs (NSAID) requesting that they make labeling changes to their products. These letters include recommended proposed labeling for both the prescription and over-the-counter (OTC) NSAIDs and a medication guide for the entire class of prescription products. All sponsors of marketed prescription Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including Celebrex (celecoxib), a COX-2 selective NSAID, have been asked to revise the labeling (package insert) for their products to include a boxed warning, highlighting the potential for increased risk of cardiovascular (CV) events and the well described, serious, potential life-threatening gastrointestinal (GI) bleeding associated with their use. The Celebrex labeling will, in addition to the general labeling that will apply to all NSAIDs, also contain safety data from long- term treatment trials with celecoxib. Manufacturers of non-prescription (over-the-counter) NSAIDs are being asked to revise their labeling to provide more specific information about the potential CV and GI risks of their individual products and remind patients of the limited dose and duration of treatment of these products in accordance with the package instructions In making these decisions, the Center for Drug Evaluation and Research (CDER) considered the risk/benefit profile for each of the drugs. Also considered was;
• review of the regulatory histories and new drug application (NDA) databases of the
• FDA and sponsor background documents prepared for the
• all materials and data submitted by other stakeholders to the Advisory Committee
meeting,presentations made at the joint meeting
• the specific votes and recommendations made by the joint Committee.
Further information regarding the decisions being announced and specific details regarding the individual products can be found within the documents posted to this Web page.
(including Bextra, Celebrex, and Vioxx)
• Prescription NSAID Products (6/15/2005)
• New July 15, 2005. The agency has issued new supplemental labeling request letters
for OTC NSAID products. The Agency received comments from industry regarding the June 14th supplemental labeling request letter and labeling template. Upon completion of our review of the comments, the Agency has decided to make revisions to the OTC labeling template and issue a new supplemental labeling request letter.
• COX-2 Selective Non-steroidal Anti-inflammatory Drugs (NSAIDs) and Prescription and
Over-the-Counter (OTC) Non-selective NSAIDs Approved Under New Drug Application (NDA) Abbreviated New Drug Application (ANDA
COX-2 Selective Drugs Bextra (valdecoxib)
On April 7, 2005, the Food and Drug Administration (FDA) asked Pfizer to voluntarily remove Bextra (valdecoxib) from the market. Background Information Celebrex (celecoxib) Background Information
• FDA Alert: 3/2005. Based on emerging information, including preliminary reports from
one of several long term National Institutes of Health (NIH) prevention studies, the risk of cardiovascular events (composite endpoint including MI, CVA and death) may be increased in patients receiving Celebrex. FDA will be analyzing all available information from these studies to determine whether additional regulatory action is needed.
Vioxx (rofecoxib)
[9/30/2004] Merck & Co., Inc. announced a voluntary withdrawal of Vioxx (rofecoxib) from the U.S. and worldwide market due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients on Vioxx. Vioxx is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms. Vioxx was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children. Background Information
• Slide Presentation by Sandra Kweder, M.D., Novembe] (Posted
Other Prescription Non-selective NSAIDs COX-2 Selective Non-steroidal Anti-inflammatory Drugs (NSAIDs) and Prescription and Over-the-Counter (OTC) Non-selective NSAIDs Approved Under New Drug Application (NDA) Abbreviated New Drug Application (ANDA) COX-2 Selective NSAIDs Chemical Name Brand Name Non-selective NSAIDs Chemical Name Brand Name
Cataflam, Voltaren, Arthrotec (combination with
Motrin, Motrin IB, Motrin Migraine Pain, Advil, Advil Migraine Liqui-gels, Ibu-Tab 200, Medipren, Cap-Profen, Tab-Profen, Profen, Ibuprohm, Children's ElixsureVicoprofen (combination with hydrocodone), Combunox (combination with oxycodone)
Indocin, Indocin SR, Indo-Lemmon, Indomethegan
Aleve, Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, Naprapac (copackaged with lansoprazole)
*There are many OTC Combinations with ibuprofen: Advil Cold And Sinus, Advil Cold, Advil Allergy Sinus, Children's Advil Allergy Sinus, Ibuprohm Cold and Sinus, Sine-Aid IB, Children's Motrin Cold.
**There are over-the-counter versions of these prescription medications. Links on this page:
1. http://www.fda.gov/ohrms/dockets/ac/cder05.html#DrugSafetyRiskMgmt2. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPro
3. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108427.htm4. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPro
5. http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPati
6. http://www.fda.govssLINK/ucm103420.htm#COX27. http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPati
8. http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPati
9. http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPati
10.http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPati
11.http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPati
12.http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPro
13.http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPro
14.http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm051900.htm15.http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPro
16.http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
fuseaction=Search.SearchAction&SearchTerm=celebrex&SearchType=BasicSearch
17.http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2004/ucm108384.htm18.http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm051900.htm19.http://www.fda.gov/NewsEvents/Testimony/ucm113235.htm20.http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPati
21.http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPati
22.http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPro
23.http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPro
24.http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandPro
viders/DrugSafetyInformationforHeathcareProfessionals/ucm085282.htm
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Centro de Ciˆencias Exatas - Departamento de Estat´ısticaP´os-gradua¸c˜ao em EnfermagemDisciplina: Bioetat´ısticaExerc´ıcios Aula 1 - Prof. Dr. Robson M. Rossi 1. Indique qual forma de pesquisa foi utilizada nos seguintes problemas:(a) ”Viagra para os diab´eticos” ( Revista isto ´e, no 1535 de 03/03/1999 ) - A famosa p´ılula azul pode tamb´emser eficaz para diab´eticos que
Celebrex es más peligroso para los pacientes 
deberían recetarles dosis bajas de este fármaco. Los resultados también deben tranquilizar a los 
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