Navigation Links
Avandia Label to Get Heart-Attack Warning
Date:11/14/2007

FDA takes action on diabetes drug although evidence is inconclusive

WEDNESDAY, Nov. 14 (HealthDay News) -- The popular diabetes drug Avandia -- which has been linked to the risk of heart failure and, more recently, heart attack -- will carry a revised "black box" warning noting the heart attack risk, even though the research on heart attack is inconclusive, U.S. officials said Wednesday.

GlaxoSmithKline, the maker of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add the new warning to the existing black box warning on the drug's label, according to U.S. Food and Drug Administration officials.

"We are announcing an update to the existing box warning on Avandia," Dr. Janet Woodcock, acting director of the FDA's Center for Drug Evaluation and Research, said during a midday teleconference. "A black box is the strongest form of warning, and we are adding another warning to that black box."

Despite the revised warning label, the FDA said it isn't seeking to have the drug withdrawn from the market, because the evidence for the increased heart-attack risk is not conclusive.

"We are keeping Avandia on the market, because we have concluded there isn't enough evidence to indicate that the risk of heart attack is higher for Avandia than other type 2 diabetes treatments," Woodcock said.

Woodcock said the FDA has asked GlaxoSmithKline to conduct a long-term study comparing Avandia with other type 2 diabetes drugs. The trial will most likely start in a year, and full results won't be available until 2014.

The new labeling follows recommendations made by the FDA's Endocrine and Metabolic Advisory Committee and Drug Safety and Risk Management Advisory Committee. In July, the committees recommended keeping Avandia on the market, pending a review of additional data. The committees also said the drug's label should carry a warning of the potential for increased risk of heart
'/>"/>

Copyright©2007 ScoutNews,LLC.
All rights reserved  

Page: 1 2 3

Related medicine news :

1. Diabetes Drug Avandia Boosts Heart Risks: Study
2. GSK Revises US Labeling for Avandia(R)
3. Prescription labels geared toward pharmacies, not patients
4. FDA: Use the Nutrition Facts Label to Make Healthy Food Choices
5. FDA Approves Expanded Label for FluMist(R) to Include Children Two to Five Years of Age
6. FDA approves expanded label for FluMist (influenza virus vaccine live, intranasal) to include childr
7. FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adult Leukemia
8. Lilly Announces Updates to the Zyprexa and Symbyax U.S. Labels
9. IOM workshop on less confusing drug labeling, Oct. 12
10. FDA Expands VELCADE(R) (Bortezomib) for Injection Label for Patients with Multiple Myeloma
11. National Patient Advocate Foundation (NPAF) Statement Regarding New FDA Label on Erythropoietin Stimulating Agents (ESAs)
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Avandia Label to Get Heart-Attack Warning
(Date:7/31/2015)... ... , ... There’s no better way to enjoy the summer weather than by ... next meal, making July the most appropriate to be National Hot Dog Month. King ... Make the next cookout different than the ones in the past. Celebrate National Hot ...
(Date:7/31/2015)... ... 2015 , ... M3 USA MDLinx.com, source of the Smartest Doc Board Exam ... , The additions of Gastroenterology, Pulmonology and Allergy/Immunology round out an already robust ... the exam easy and painless. MDLinx offers thousands of board-exam style questions and ...
(Date:7/31/2015)... ... July 31, 2015 , ... Well-known for its unique pastries and delicious ... with custom designs, making life just a little bit sweeter for newlyweds. A ... each customer who orders one. , The bakery provides a full line of custom ...
(Date:7/31/2015)... , ... July 31, 2015 , ... ... one-day event geared to patients and family members, medical professionals, and researchers, covering ... mesothelioma experts. The conference is a collaborative effort between the Mesothelioma Applied Research ...
(Date:7/31/2015)... ... July 31, 2015 , ... Girl Scouts of Historic Georgia and Peach State ... Girl Scout "Be a Friend First" program. Representatives from Peach State Health Plan presented ... State Health Plan and our parent company, Centene Corporation, are dedicated to raising anti-bullying ...
Breaking Medicine News(10 mins):Health News:King Kullen Honors National Hot Dog and Blueberry Month 2Health News:King Kullen Honors National Hot Dog and Blueberry Month 3Health News:MDLinx Offers Three New Board Exam Prep Courses - Gastroenterology, Pulmonology and Allergy/Immunology 2Health News:MDLinx Offers Three New Board Exam Prep Courses - Gastroenterology, Pulmonology and Allergy/Immunology 3Health News:Pastry Palace of Las Vegas Announces It Is Now Offering Custom Wedding Cakes in Las Vegas 2Health News:New York Area Mesothelioma Specialists to Present at Conference 2Health News:New York Area Mesothelioma Specialists to Present at Conference 3Health News:Peach State Health Plan Presents $10,000 Check for “Be a Friend First” Anti-Bullying Program to Local Girl Scouts 2
... will help treat baldness by growing new hair follicle cells//. ... hair follicles from the back of the neck, multiplying them ... BBC News. ,It initially tested the treatment on ... hair. They are to test the treatment on 20 more ...
... group of pioneering psychiatrists who worked in Saskatchewan, Canada in ... Dyck, who is working on it for the last 5 ... the University of Alberta, sited records of the psychiatrists' research, ... single dose of the hallucinogenic drug LSD, administered in a ...
... A team of scientists from the University of Adelaide, ... world breakthrough in understanding how bacterial toxins cause// severe ... Adrienne Paton from the University of Adelaide’s School of ... potent bacterial toxin kills cells by inactivating an essential ...
... Paswan promises a new policy for the poor that will ... tuberculosis, AIDS and cancer. ,"By Jan 1 we ... will offer free medication to the poor," Paswan said in ... with the help of the drug manufacturers who have agreed ...
... surgeons at The Methodist Hospital shows unprecedented improvements in ... Lucentis? for wet// age-related macular degeneration (AMD), according to ... Medicine. AMD is a major cause of central visual ... blindness in people over 60. ,Dr. David ...
... revealed that behavioral therapies can benefit children who have problems ... ,The American Academy of Sleep Medicine (AASM) appointed a ... babies and toddlers. ,According to study author Jodi ... have shown 20 to 30 percent of young children have ...
Cached Medicine News:Health News:Effective Cure for Alcoholism – A single dose of LS 2Health News:Effective Cure for Alcoholism – A single dose of LS 3Health News:Scientists Make World Breakthrough 2Health News:Free Medicines, Health Insurance for Poor Soon: Paswan 2Health News:Results for Wet Age-Related Macular Degeneration Show Significant Vision Improvements 2
(Date:7/31/2015)... , July 31, 2015 ... for video, data and cloud computing operators has ... leading pharma giant for Internet of Things (IoT) ... applications offered on subscription model.      ... giant is striving for business innovations to make ...
(Date:7/30/2015)... 30, 2015 IRIDEX Corporation (NASDAQ: IRIX ... quarter 2015 financial results after the market closes on ... the release, the Company will host a conference call ... Time on Thursday, August 6, 2015 ... business developments. Interested parties may access the ...
(Date:7/30/2015)... 30, 2015  Today we bring you a special edition of #MedicareMonday on Medicare,s ... about some of our Medicare resources and continue highlighting the success of the prescription ... Check out our latest infographics and videos here: http://onphr.ma/1INp9qQ ... ... ...
Breaking Medicine Technology:Magnaquest Signs a POC With a Leading Pharma Giant in Europe to Manage Subscription Management and Billing for Internet of Things (IoT) 2IRIDEX Announces Second Quarter 2015 Conference Call and Release Date 2Happy 50th Anniversary Medicare! 2Happy 50th Anniversary Medicare! 3
... 2011 Total quarterly revenues of ... grow 17 Percent, reflecting strong performance of OPANA® ER, Voltaren® Gel ... of $0.34 versus $0.46 for prior year ... from 2010 Company reaffirms 2011 guidance ...
... Ohio, Oct. 27, 2011 Cardinal Health today reported ... an 11 percent increase in non-GAAP diluted earnings per ... EPS from continuing operations declined 19 percent to $0.68, ... of CareFusion stock. Strong revenue growth was driven by ...
Cached Medicine Technology:Endo Pharmaceuticals Reports Strong Third-Quarter Financial Results and Reaffirms 2011 Financial Guidance 2Endo Pharmaceuticals Reports Strong Third-Quarter Financial Results and Reaffirms 2011 Financial Guidance 3Endo Pharmaceuticals Reports Strong Third-Quarter Financial Results and Reaffirms 2011 Financial Guidance 4Endo Pharmaceuticals Reports Strong Third-Quarter Financial Results and Reaffirms 2011 Financial Guidance 5Endo Pharmaceuticals Reports Strong Third-Quarter Financial Results and Reaffirms 2011 Financial Guidance 6Endo Pharmaceuticals Reports Strong Third-Quarter Financial Results and Reaffirms 2011 Financial Guidance 7Endo Pharmaceuticals Reports Strong Third-Quarter Financial Results and Reaffirms 2011 Financial Guidance 8Endo Pharmaceuticals Reports Strong Third-Quarter Financial Results and Reaffirms 2011 Financial Guidance 9Endo Pharmaceuticals Reports Strong Third-Quarter Financial Results and Reaffirms 2011 Financial Guidance 10Endo Pharmaceuticals Reports Strong Third-Quarter Financial Results and Reaffirms 2011 Financial Guidance 11Endo Pharmaceuticals Reports Strong Third-Quarter Financial Results and Reaffirms 2011 Financial Guidance 12Endo Pharmaceuticals Reports Strong Third-Quarter Financial Results and Reaffirms 2011 Financial Guidance 13Endo Pharmaceuticals Reports Strong Third-Quarter Financial Results and Reaffirms 2011 Financial Guidance 14Endo Pharmaceuticals Reports Strong Third-Quarter Financial Results and Reaffirms 2011 Financial Guidance 15Endo Pharmaceuticals Reports Strong Third-Quarter Financial Results and Reaffirms 2011 Financial Guidance 16Endo Pharmaceuticals Reports Strong Third-Quarter Financial Results and Reaffirms 2011 Financial Guidance 17Cardinal Health Reports First-Quarter Results 2Cardinal Health Reports First-Quarter Results 3Cardinal Health Reports First-Quarter Results 4Cardinal Health Reports First-Quarter Results 5Cardinal Health Reports First-Quarter Results 6Cardinal Health Reports First-Quarter Results 7Cardinal Health Reports First-Quarter Results 8Cardinal Health Reports First-Quarter Results 9Cardinal Health Reports First-Quarter Results 10Cardinal Health Reports First-Quarter Results 11Cardinal Health Reports First-Quarter Results 12Cardinal Health Reports First-Quarter Results 13Cardinal Health Reports First-Quarter Results 14Cardinal Health Reports First-Quarter Results 15Cardinal Health Reports First-Quarter Results 16Cardinal Health Reports First-Quarter Results 17Cardinal Health Reports First-Quarter Results 18
... chairs with concave seats and large backrests ... seats, backrests, armrests, and casters and glides. ... performance in a variety of environments including: ... health care and office. • With tubular ...
... Durable ergonomic chairs with concave seats and ... options like seats, backrests, armrests, and casters ... for top performance in a variety of ... static control, health care and office. • ...
... chairs with concave seats and large backrests ... seats, backrests, armrests, and casters and glides. ... performance in a variety of environments including: ... health care and office. • With tubular ...
Contoured waterfall-front ergonomic seats and generous backrests with lumbar support are standard on these ergonomic chairs. • With Tubular Base....
Medicine Products: