Navigation Links
Consumer Group Seeks FDA Ban on Avandia
Date:10/30/2008

Public Citizen cites liver failure deaths, other risks of adverse events for diabetes drug

THURSDAY, Oct. 30 (HealthDay News) -- The diabetes drug Avandia should be banned in the United States because it can cause death from liver failure and poses many other life-threatening risks that greatly outweigh its benefits, the advocacy group Public Citizen said Thursday.

The group said it has identified 14 cases of Avandia-induced liver failure, including 12 deaths. The cases were found in the U.S. Food and Drug Administration's Adverse Event Reporting System.

Public Citizen's call for an FDA ban on Avandia (generic name rosiglitazone) comes as an American Diabetes Association/European Association for the Study of Diabetes working group unanimously advised against the use of the drug. The working group's statement appears in the current issue of Diabetes Care.

"The scientific evidence against Avandia is overwhelming," Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a Public Citizen news release. "The timing of these findings should give the FDA the momentum it needs to act swiftly to prevent further needless deaths and health damage by banning this drug."

Liver toxicity is the latest problem linked to Avandia. According to Public Citizen, the drug increases the risk of heart attack by about 40 percent, doubles the risk of heart failure and bone fractures, and increases the risk of anemia and vision loss from macular edema, a swelling of the retina caused by fluid accumulation in the eye.

Use of Avandia declined after a study connecting the drug with increased heart attack risk was published in New England Journal of Medicine in May 2007. The number of people taking Avandia declined from a peak of 13.2 million in 2006 to 4.6 million for the last full year. That means that about 10,000 prescriptions a day are still being filled for the drug, Public Citizen said.

The group said safer, more effective drugs for type 2 diabetes included metformin (brand name Glucophage) and glipizide (brand name Glucotrol). Pioglitazone (brand name Actos) isn't recommended, because it shares most of Avandia's toxicities, with the exception of heart attack risk.

Avandia is sold by GlaxoSmithKline. In a statement, the company said that it had not yet looked at the petition but said that "we do not believe there is a connection between liver toxicity and this medicine," the Wall Street Journal reported Thursday. Avandia was safe and effective when used appropriately, the company added.

An estimated 20.4 million Americans have type 2 diabetes, which can lead to kidney failure, blindness and heart disease. About 75 percent of diabetics die from cardiovascular disease.

In July, an FDA advisory panel said drugs designed to control type 2 diabetes should be subjected to more thorough safety reviews to ensure they don't raise the risk of heart problems. They recommended that all makers of these drugs conduct long-term cardiovascular trials, even if the drugs show no signs of heart problems in initial trials.

Most of the outside experts on the panel also said that trials assessing cardiovascular risk should be done before a drug is approved, perhaps as part of a phase III trial, to rule out any significant heart risk. Long-term trials could follow once the drug was on the market.

Currently, the FDA only requires that drugs for type 2 diabetes lower blood sugar, which is believed to protect diabetics from the debilitating side effects of the disease.

More information

Consumers Union has more about diabetes drugs.



-- Robert Preidt



SOURCE: Public Citizen, news release, Oct. 30, 2008


'/>"/>
Copyright©2008 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. URAC Rolls Out Revised Standards to Protect Personal Health Information and Boost Consumer Privacy on the Web
2. NaturalNews Posts Audio Interview with Consumer Chemical Expert Debra Lynn Dadd on Bisphenol-A
3. CVS Caremark Partners with Google Health to Provide Consumers with Online Access to their Prescription History through Caremark.com
4. California Insurers are Behind the Curve with Consumer-Driven Health Plans
5. NQF Endorses Guidelines for Consumer-Focused Public Reporting
6. Consumers and plastic surgeons say economy is cutting into cosmetic procedures
7. Consumers and Plastic Surgeons Say Economy Is Cutting Into Cosmetic Procedures
8. Research Shows Consumer-Directed Health Plans Encourage Preventive Care
9. Report Confirms Consumer Selection is a Driving Force in Health Care Today
10. New Study Reveals Consumers Want Greater Say in Key Food Issues
11. Health Care Management Thought Leaders Converge for Summit on Cost, Quality and Consumer Focus
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Consumer Group Seeks FDA Ban on Avandia
(Date:5/26/2016)... ... May 26, 2016 , ... There are nearly 14.5 million ... million cancer survivors worldwide. On Sunday, June 5, 2016, communities around the world will ... Survivors Day®. , National Cancer Survivors Day® is an annual worldwide Celebration of ...
(Date:5/26/2016)... , ... May 26, 2016 , ... In an effort to provide hair restoration information ... both Snapchat users and those who do not use the app. Dr. Mohebi, the founder ... page, Dr. Mohebi Live . , Dr. Mohebi says, “The positive response to ...
(Date:5/26/2016)... ... May 26, 2016 , ... North Cypress Medical ... at Blackhorse Golf Club in Cypress. With the help of community partners, the event ... empowers, and renews hope for wounded service members and their families through health, wellness, ...
(Date:5/26/2016)... ... May 26, 2016 , ... Power Systems, a leading developer ... Instructor Certification Course in Stoughton, Massachusetts. The course was led by Power Systems’ ... 8 hour interactive course to qualify participants as certified PowerWave trainers. , ...
(Date:5/26/2016)... ... ... The introduction of our professional athletes coincides with the company’s new campaign: “LOOK ... are proud to introduce Meghan Klingenberg, defender and World Champion with the US Women’s ... Los Angeles who was a second round selection in the 2012 NFL draft. We ...
Breaking Medicine News(10 mins):
(Date:5/24/2016)... -- Open Access Journal Focusing on ... Elsevier , a world-leading provider of scientific, technical ... launch of Clinical Neurophysiology Practice ... clinical practice issues in clinical neurophysiology. The journal will ... and didactic reviews. It is an official journal of ...
(Date:5/23/2016)... , May 23, 2016 ... Handling Equipment Market by Product (Wheelchair, Scooters, Medical ... (Bariatric Care, Critical Care, Wound), Accessories (Lifting, Transfer) ... to 2021", published by MarketsandMarkets, the patient handling ... Billion by 2021 at a CAGR of 10.5% ...
(Date:5/23/2016)... ALBANY, New York , May 23, 2016 /PRNewswire/ ... new market report titled, " Exocrine Pancreatic Insufficiency Market ... Forecast 2013 - 2023 ." According to the report, ... at a CAGR of 8.3% from 2015 to 2023 ... pancreatic insufficiency (EPI) is a condition characterized by the ...
Breaking Medicine Technology: