Navigation Links
FDA Concludes There is No Increased Risk of Cardiac Events for Patients Treated with omeprazole and NEXIUM(R) (esomeprazole magnesium)
Date:12/10/2007

WILMINGTON, Del., Dec. 10 /PRNewswire-FirstCall/ -- The US Food and Drug Administration (FDA) today issued its final assessment of two small, open, long-term, clinical studies in patients with gastro-esophageal reflux disease (GERD), comparing anti-reflux surgery with either omeprazole (SOPRAN study) or NEXIUM(R) (LOTUS study) treatment.

AstraZeneca (NYSE: AZN) agrees with the FDA conclusion which states "FDA continues to conclude that long-term use of these drugs is not likely to be associated with an increased risk of heart problems. FDA recommends that health care providers continue to prescribe, and patients continue to use, these products as described in the labeling for the two drugs." AstraZeneca also supports the conclusion made by the FDA that the overall benefit/risk profiles of omeprazole and NEXIUM remain unchanged. AstraZeneca continues to be confident in the safety profiles of omeprazole and NEXIUM.

The conclusion confirms the public announcement made on August 9, 2007 when the FDA stated that preliminary evaluation of the SOPRAN and LOTUS data does not suggest an increased risk of cardiac events for patients treated with omeprazole or NEXIUM. This announcement was in response to a communication sent to worldwide Health Authorities by AstraZeneca in May 2007 regarding the SOPRAN and LOTUS studies.

PRILOSEC(R)/LOSEC (omeprazole)(*) was first launched outside the US in 1988 and in the US in 1989. NEXIUM was first launched outside the US in 2000 and in the US in 2001. Proton Pump Inhibitors (PPIs) have been shown to be beneficial for patients with gastroesophageal reflux disease (GERD). PPIs are generally well tolerated and PRILOSEC/LOSEC and NEXIUM have been used in the management of GERD in over 1 billion
'/>"/>

SOURCE AstraZeneca
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Seriously Low Vaccination Rates Cause Experts to Call for Increased Immunization Before Influenza Season Peaks
2. Study Shows Vasopressin Receptor Antagonist VAPRISOL(R) (Conivaptan Hydrochloride Injection) Significantly Increased Serum Sodium Concentration in Patients with Euvolemic & Hypervolemic Hyponatremia
3. EntreMed Shows Increased Survival With MKC-1 in Preclinical Renal Cell Cancer Model
4. Superbug Outbreak Calls for Immediate Increased Attention on Infection Control
5. Data Presented at the American Heart Association Scientific Sessions 2007 Demonstrated Increased HDL with ACTOS(R) (pioglitazone HCl) Slowed the Progression of Carotid Intima-Media Thickness in Patients with Type 2 Diabetes
6. FORTEO(R) Increased Spine Bone Mineral Density in Patients with Glucocorticoid-Induced Osteoporosis
7. Personalized Medicine - The Genomic Revolution in Cardiac Care
8. FAU Receives Patent for Invention Which Induces and Restores Cardiac Muscle Function
9. Signalife Completes Testing of Modules for Holter and Intra-Cardiac Monitor
10. Abbotts XIENCE(TM) V Everolimus Eluting Coronary Stent Shows Continued Superiority to TAXUS Stent in Reducing Major Adverse Cardiac Events in SPIRIT III Clinical Trial
11. Study Shows Vernakalant Hydrochloride is Effective in Conversion to Normal Heart Rhythm in Atrial Fibrillation Patients Following Cardiac Surgery
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/31/2015)... Aug. 31, 2015  Soligenix, Inc. (OTCQB: ... company developing products that address unmet medical needs ... announced today it has completed enrollment of the ... Committee (DRC) earlier this year, into the company,s ... first-in-class innate defense regulator (IDR) and is being ...
(Date:8/31/2015)... 2015  Asterias Biotherapeutics, Inc. (NYSE MKT: AST), ... of regenerative medicine, today announced that the third ... -based Rush University Medical Center in a ... doses of AST-OPC1 (oligodendrocyte progenitor cells) in newly ... spinal cord injury (SCI). This represents the final ...
(Date:8/31/2015)... N.J. and STAMFORD, Conn. ... pharmaceutical subsidiary of Eisai Co., Ltd., and Purdue Pharma ... worldwide collaboration agreement for the development and commercialization of ... orexin receptor antagonist entering Phase III clinical development for ... terms of the agreement, Eisai and Purdue Pharma will ...
Breaking Medicine Technology:Soligenix Announces Completion of Patient Enrollment into its Phase 2 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer Patients 2Soligenix Announces Completion of Patient Enrollment into its Phase 2 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer Patients 3Soligenix Announces Completion of Patient Enrollment into its Phase 2 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer Patients 4Soligenix Announces Completion of Patient Enrollment into its Phase 2 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer Patients 5Soligenix Announces Completion of Patient Enrollment into its Phase 2 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer Patients 6Asterias Biotherapeutics Concludes Recruitment of Initial Safety Cohort of the SCiStar Phase 1/2a Dose-Escalation Clinical Trial of AST-OPC1 for Complete Cervical Spinal Cord Injury 2Asterias Biotherapeutics Concludes Recruitment of Initial Safety Cohort of the SCiStar Phase 1/2a Dose-Escalation Clinical Trial of AST-OPC1 for Complete Cervical Spinal Cord Injury 3Asterias Biotherapeutics Concludes Recruitment of Initial Safety Cohort of the SCiStar Phase 1/2a Dose-Escalation Clinical Trial of AST-OPC1 for Complete Cervical Spinal Cord Injury 4Asterias Biotherapeutics Concludes Recruitment of Initial Safety Cohort of the SCiStar Phase 1/2a Dose-Escalation Clinical Trial of AST-OPC1 for Complete Cervical Spinal Cord Injury 5Asterias Biotherapeutics Concludes Recruitment of Initial Safety Cohort of the SCiStar Phase 1/2a Dose-Escalation Clinical Trial of AST-OPC1 for Complete Cervical Spinal Cord Injury 6Eisai and Purdue Pharma Enter Worldwide Collaboration to Develop and Commercialize Lemborexant 2Eisai and Purdue Pharma Enter Worldwide Collaboration to Develop and Commercialize Lemborexant 3Eisai and Purdue Pharma Enter Worldwide Collaboration to Develop and Commercialize Lemborexant 4Eisai and Purdue Pharma Enter Worldwide Collaboration to Develop and Commercialize Lemborexant 5
... , HELSINKI, Dec. 14 Cancer ... with the introduction of RapidArc® radiotherapy technology from Varian Medical ... radiotherapy clinic in the Nordic region. Clinicians at Docrates Clinic ... radiotherapy to treat patients with multiple brain metastases and cancers ...
... , WALTHAM, Mass., Dec. ... authority on medical technology market intelligence, increased use of safety ... be a key driver of the enteral feeding device markets ... and European Markets for Enteral Feeding Devices 2010 report ...
Cached Medicine Technology:Cancer Patients in Finland Gain Access to Advanced RapidArc Radiotherapy Treatments 2Cancer Patients in Finland Gain Access to Advanced RapidArc Radiotherapy Treatments 3Enteral Feeding Device Market To Generate More Than $700 Million in the US & Europe by 2014 2Enteral Feeding Device Market To Generate More Than $700 Million in the US & Europe by 2014 3
(Date:9/1/2015)... ... September 01, 2015 , ... Anthony J. Tantillo, Esq., Attorney from William ... third consecutive year in a row. Through nomination, research and strategic evaluation processes, ... in Niagara Falls, New York, Tantillo is a Buffalo State College graduate of 1998. ...
(Date:9/1/2015)... ... ... A new episode of “Voices In America”, hosted by famous actor and ... arthritis. There are over 100 different types of arthritis. One of the most popular ... effort to shed light on this important topic. , Anyone who is nearing their ...
(Date:9/1/2015)... ... September 01, 2015 , ... September is Baby Safety Month, and ... labels and stickers to keep little ones' safety top of mind at all times. ... a particular focus. According to the JPMA's Baby Safety Zone website, this year's theme ...
(Date:9/1/2015)... (PRWEB) , ... September 01, 2015 , ... ... professionals, PRESENT e-Learning Systems, has become a leader in podiatric, ... residency education. The Superbones Superwounds Conferences place top national speakers at the podium ...
(Date:8/31/2015)... , ... September 01, 2015 , ... ... today announced the release of ten hours of new premium on-demand video ... Certification members. , Athletic Trainers certified before 2014 must complete 50 CEUs before ...
Breaking Medicine News(10 mins):Health News:Lightning Labels Can Help Make A Difference This Baby Safety Month 2Health News:Lightning Labels Can Help Make A Difference This Baby Safety Month 3Health News:PRESENT e-Learning Systems Announces their 2016 Podiatry and Wound Care Medical Education Conference Schedule 2Health News:Evidence Based Practice Courses: CEUs For Athletic Trainers Just Released 2
... Center for Healthier Children, Families and Communities has been ... the National Childrens Study, a nationwide project designed to ... childrens health in the United States. The study center ... the largest study of child health ever conducted in ...
... talking Mitt,Romney is heading back to the Granite ... veto of legislation that would provide health care ... September 25,2007] Despite recent polls showing that seven ... provided health insurance to 10 million children,across the ...
... October 4, 2007 A group working at the ... with the University of Pavia has discovered that telomeres, ... that progressively shorten every time a cell divides, also ... Science Express, calls into question our understanding of how ...
... Week on Capitol Hill Drives,Efforts to Increase Research, ... Calif., Oct. 4 The Coalition for,Pulmonary Fibrosis ... fifth,annual National IPF Awareness Week, which included meetings ... need to fund new research into,idiopathic pulmonary fibrosis ...
... following statement was issued,today by the law firms Schiffrin ... LLC: Out of public health concerns and in ... E. coli contaminated ground beef products,SCHIFFRIN BARROWAY TOPAZ & ... a registry for victims of E. coli poisoning to ...
... The Academy of General,Dentistry (AGD) was extremely ... State Children,s Health Insurance Program (SCHIP),reauthorization bill. The ... of Congress included many important and beneficial dental,provisions ... our nation,s,children. However, President Bush, who had threatened ...
Cached Medicine News:Health News:UCLA to lead local study center in landmark government study of child health 2Health News:UCLA to lead local study center in landmark government study of child health 3Health News:UCLA to lead local study center in landmark government study of child health 4Health News:DNC: Romney an (S)CHIP Off the Bush Republican Block 2Health News:DNC: Romney an (S)CHIP Off the Bush Republican Block 3Health News:New telomere discovery could help explain why cancer cells never stop dividing 2Health News:CPF Urges Congress to Increase Funding for IPF Research in 2009 Federal Budget 2Health News:CPF Urges Congress to Increase Funding for IPF Research in 2009 Federal Budget 3Health News:CPF Urges Congress to Increase Funding for IPF Research in 2009 Federal Budget 4Health News:Establishment of Topps Meat Recall Registry for Victims of E. Coli Poisoning 2Health News:Establishment of Topps Meat Recall Registry for Victims of E. Coli Poisoning 3Health News:AGD Concerned With Presidential Veto of SCHIP Reauthorization Bill 2Health News:AGD Concerned With Presidential Veto of SCHIP Reauthorization Bill 3
... Splint is constructed of a durable heat moldable ... flexor tendons of the hand and fingers from ... in the later stages of the healing process. ... hand and positions the wrist at 30° of ...
Bunell Mini-Modified Safety Finger Pin reduces PIP flexion contractures....
... FoamWrap Finger Trappers are ideal for ... restore finger motion. Finger Trappers' non-slip foam ... place the fingers in traction. These are ... size. Sold in packages of 5 and ...
... physiological causes of minor knee pain like ... in concert with the motion of the ... and patellar tendon and assisting in the ... plastic support with high density foam padding ...
Medicine Products: