Navigation Links
Remove Diabetes Drug Avandia From Market: FDA Documents
Date:2/20/2010

Trying to sort things out, in December of 2009 Woodcock asked officials at the FDA to convene another advisory committee to determine whether Avandia should remain on the market, with a decision expected this summer.

In the meantime, a bipartisan Senate investigation -- overseen by Sen. Max Baucus (D-Mont.) and Sen. Charles E. Grassley(R-Iowa) -- has pored over 250,00 internal documents from GlaxoSmithKline. The investigation has placed much of the blame for the Avandia debacle on the company, contending that it neglected to warn patients for years of the drug's dangers.

"G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk," according to the Senate investigation report, which is slated for release Monday but was obtained early by the Times.

Speaking to the newspaper Friday night, agency commissioner Dr. Margaret Hamburg said that, "I await the recommendations of the advisory committee. Meanwhile, I am reviewing the inquiry made by Senators Baucus and Grassley and I am reaching out to ensure that I have a complete understanding and awareness of all of the data and issues involved."

In a statement released Saturday, GlaxoSmithKline said it "rejects the conclusions about the safety of Avandia (rosiglitazone)" as reported in that day's Times story.

"Contrary to the assertions in the story, and consistent with the FDA-approved labeling, the scientific evidence simply does not establish that Avandia increases ischemic cardiovascular risk or causes myocardial ischemic events," the company said. "In 2007, the FDA considered all the available scientific evidence on Avandia, including Dr. Grahams assertions of elevated heart attack risk and demands that the product be withdrawn. Based on the scien
'/>"/>

Copyright©2010 ScoutNews,LLC.
All rights reserved

Page: 1 2 3 4 5

Related medicine news :

1. Single-incision belly-button surgery to remove kidney performed first at UT Southwestern
2. Surgeons Remove Gallbladder Through Vagina
3. CVS/pharmacy to Remove OTC Infant Cough & Cold Products from Its Stores as Part of CHPAs Voluntary Withdrawal
4. Prominent Farmington Plastic Surgeon Uses Two New Non-Surgical Procedures to Tighten Skin and Remove Fat
5. Stop & Shop Removes Childrens Cough and Cold Medicine from Store Shelves
6. Giant Food Removes Childrens Cough and Cold Medicine From Store Shelves
7. Schwarzenegger Signs Bill to Remove Written Informed Consent for HIV Testing; "Most Important Change in Public HIV/AIDS Policy in Years," Says AHF
8. Health Groups Call on Cosmetic Giant LOreal to Remove Lead From Lipstick
9. Video: Trinity Mother Frances Neurosurgeon First in Region to Remove Brain Tumor Using Unique Surgical Procedure
10. Nations Largest Pet Insurer Reveals Top 10 Items Surgically Removed From Pets
11. Safety Concerns Prompt Prime to Remove Avandia(R) from Formulary
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/3/2015)... Indiana Fiber Network, LLC (IFN), the leading ... Inc (BCS) has selected IFN as a fiber transport ... service, and working relationship with IFN has been great, ... you get with IFN. I like dealing with ... decisions and operates as a local community business partner.” ...
(Date:5/3/2015)... (PRWEB) May 03, 2015 SpineFrontier, a ... from the FDA to produce and market their new ... can be used in outpatient settings and is compatible ... alternate posterior approach has been extensively researched and refined ... approval to use this approach in conjunction with a ...
(Date:5/2/2015)... NV (PRWEB) May 02, 2015 Ticket Down ... tickets for the long awaited event today, Saturday, May ... Diehard boxing fans will be able to secure tickets ... , The fight that boxing fans have wanted for more ... months ago. Floyd “Money” Mayweather will step inside the ring ...
(Date:5/2/2015)... May 02, 2015 It’s a pattern ... natural disaster strikes anywhere on this planet, cyber scammers ... sympathy and compassion for their own personal gain. ... Emergency Readiness Team) issued an alert titled “Nepal ... email scams citing the earthquake in Nepal. The scam ...
(Date:5/2/2015)... Kare Visits LLC. launched in Chicago in ... Kare Visits offers relief for caregivers by visiting loved ... According to the Caregiver Action Network, eight in ten ... hours a week caring for an elderly or disabled loved ... a nurse, a caregiver is now empowered to schedule an ...
Breaking Medicine News(10 mins):Health News:Bank Computer Services, Inc Selects Indiana Fiber Network, LLC as Fiber Transport Provider 2Health News:Bank Computer Services, Inc Selects Indiana Fiber Network, LLC as Fiber Transport Provider 3Health News:Cheap Floyd Mayweather vs. Manny Pacquiao Tickets: Ticket Down Has Last Minute Tickets for Mayweather vs. Pacquiao at the MGM Grand Garden Arena in Las Vegas 2Health News:Cheap Floyd Mayweather vs. Manny Pacquiao Tickets: Ticket Down Has Last Minute Tickets for Mayweather vs. Pacquiao at the MGM Grand Garden Arena in Las Vegas 3Health News:Cyber Aftershocks from Nepal’s Earthquake Can Cripple Businesses Right Here at Home 2Health News:Cyber Aftershocks from Nepal’s Earthquake Can Cripple Businesses Right Here at Home 3Health News:Cyber Aftershocks from Nepal’s Earthquake Can Cripple Businesses Right Here at Home 4Health News:Chicagoan Seeks to Transform Industry by Launching an Innovative Elderly Care Solution 2
... ... affordable drug and alcohol rehab programs. Mountainside in Connecticut cites a sharp increase in demand ... increase in alcoholic binge drinking, drug abuse and marital problems. , ... (PRWEB) December 3, 2009 -- Mountainside Affordable Addiction Treatment ...
... Dec. 3 The American Association for Cancer Research (AACR) ... date on passive smoking and breast cancer in women conducted ... , Study data revealed that women who never smoked ... a lifetime--especially during adulthood--had a significantly increased breast cancer risk ...
... , PASADENA, Calif., ... businesses, the risk of disability remains one of the most ... but also their business,s viability. , "As the recession ... businesses are recognizing the need to shore up their financial ...
... , WAYNE, Pa., Dec. ... InterComponentWare Inc. (ICW), a global leader in eHealth technology, to ... Exchange (HIE). ICW will implement its Enterprise Master Patient ... (IPF) across 6 counties, 470,000 residents, 8 hospitals, and over ...
... replicating in the livers of primates , , THURSDAY, Dec. ... C has shown promise in a primate study. , The ... hepatitis C virus from replicating. Unlike other antivirals that target ... RNA molecule in the liver that hepatitis C needs to ...
... The following is being released by Common Cause ... Patrick Leahy (D-Vt.) is offering an amendment to the ... insurance industry,s legal exemptions for violations such as price ... fiercely opposes the repeal, which would subject health insurance ...
Cached Medicine News:Health News:Economic Crisis Causes Acute Demand for Affordable Drug Addiction Treatment 2Health News:Northern California Cancer Center's Findings on Breast Cancer and Secondhand Smoke Released Internationally by the American Association for Cancer Research 2Health News:New Disability Income Insurance Options Provide More Choice for California's Small Business Owners 2Health News:New Disability Income Insurance Options Provide More Choice for California's Small Business Owners 3Health News:New Disability Income Insurance Options Provide More Choice for California's Small Business Owners 4Health News:Southern Tier HealthLink NY Selects InterComponentWare to Deliver Core Components of HIE 2Health News:New Hepatitis C Treatment Shows Promise 2Health News:New Hepatitis C Treatment Shows Promise 3Health News:Health Insurance Industry Once Again Hoping Investment Pays Off 2Health News:Health Insurance Industry Once Again Hoping Investment Pays Off 3Health News:Health Insurance Industry Once Again Hoping Investment Pays Off 4Health News:Health Insurance Industry Once Again Hoping Investment Pays Off 5Health News:Health Insurance Industry Once Again Hoping Investment Pays Off 6Health News:Health Insurance Industry Once Again Hoping Investment Pays Off 7Health News:Health Insurance Industry Once Again Hoping Investment Pays Off 8
(Date:5/1/2015)... 1, 2015  Shares of Aerie Pharmaceuticals, Inc. (NASDAQ: ... yesterday following the results of the Phase 3 Rocket ... the trial failing to meet its end points, compelling ... come from future studies. An analyst report ... pipeline, financial review, analyst summary, valuation, and recommendation can ...
(Date:4/30/2015)... 2015  Accuray Incorporated (Nasdaq: ARAY ) ... with MIM Software Inc. to further develop adaptive ... ® product portfolios. The new software solution ... is Accuray,s second collaboration with MIM; the previous ... iPad-based treatment plan review capability, PlanTouch™. ...
(Date:4/30/2015)...   Regulus Therapeutics Inc . (NASDAQ: RGLS ... of innovative medicines targeting microRNAs, today announced that it ... ended March 31, 2015 on Thursday, May 7, 2015, ... Regulus will host a conference call and webcast on ... Time to discuss its first quarter 2015 financial results ...
Breaking Medicine Technology:All is Not Lost for Aerie Pharmaceuticals - VLM Research Issued by BrokerBank Securities, Inc. 2Accuray Signs Agreement with MIM Software Inc. to Develop Adaptive Therapy Software 2Accuray Signs Agreement with MIM Software Inc. to Develop Adaptive Therapy Software 3Regulus Announces Timing for First Quarter 2015 Financial Results Webcast and Conference Call 2Regulus Announces Timing for First Quarter 2015 Financial Results Webcast and Conference Call 3
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
Medicine Products: