Navigation Links
FDA Mislead On Asthma Drug By GlaxoSmithKline

Charges have been held against, a London based leading drug company, GlaxoSmithKline for having presented incorrect data regarding an anti-asthmatic drug, Serevent to the U.S. Food and Drug Administration two years ago when the // medicine came up for a review. This became evident last November when The FDA identified Serevent as a drug that needed additional warnings.

The Public Citizen Group has registered a case regarding the issue. The company is said to have manipulated from the so-called SMART trial, which was initiated in 1996. The study was conducted on a group of asthma patients for 28 weeks who received either Serevent, also known as salmeterol, or a placebo. An increased risk of asthma-related death in those who had consumed the drug has been documented.

However, Glaxo is said to have misled the FDA when it submitted six months of post- trial data in July 2003, along with the study's actual 28 weeks of data. There is a belief that the data presented is an underestimated projection of the apparent dangers associated with salmeterol, including asthma related death. The SMART data has never been published.

``GlaxoSmithKline did not clearly inform the FDA that the final study included data from six months after the trial had concluded until the FDA inquired about the results in April, 2004,'' according to those who have filed the case.

The company in response has issued a statement stating that the SMART study data were collected and analyzed by an independent clinical research organization, not by them.

“After discussions with the Data Safety Monitoring Board, Glaxo was provided with unmasked results of the interim analysis and subsequently terminated the study. The SMART trial was stopped on Jan. 23, 2003, a “Dear Healthcare Professional letter'' was delivered overnight to all U.S. doctors who had prescribed salmeterol, and notices were posted on both the FDA and Glaxo websites,'' said Mr. Kathy Rick
'"/>




Page: 1 2

Related medicine news :

1. Misleading anti-malarial drug
2. Misleading Advertisements for Prescription Drugs
3. The Effects Of Smoking Misleading
4. Lifting The Screen off Misleading Sunscreen labels
5. Misleading Health Claims On Food Labels No Longer Allowed in EU
6. Walkers Crisps Advertisements make Misleading Claims about Salt Content
7. Medical Council Of India Draws Public Attention on Misleading Ads.
8. Obesity Drug Advertisements Misleading Teens
9. Labeling of Dairy Products with Trans fat labels, Misleading to Consumers
10. New Drug for Bronchial Asthma
11. Asthma may actually be prevented by Dust and Dirt
Post Your Comments:
*Name:
*Comment:
*Email:
TAG: FDA Mislead Asthma Drug GlaxoSmithKline

(Date:3/26/2015)... 26, 2015 Building off their ... medical education, the Cardiometabolic Risk Summit ... Tulane University are proud to announce a ... The interdisciplinary program , which ultimately grants ... designed for physicians, nurse practitioners, physician assistants, registered ...
(Date:3/26/2015)... Visiting Nurse Association of Northern ... gala fundraiser, Lighting the Way, Brightening the Day, on ... Madison Hotel in Morristown, NJ. , Guests will ... musician Rio Clemente, delightful cuisine, an extensive silent auction ... Additionally, two prestigious awards will be presented to this ...
(Date:3/26/2015)... 26, 2015 Dr. Alex Rabinovich and ... announce expanded offerings for Bay Area patients considering dental ... Center has long been a top-rated center, serving primarily ... to meet the strong demand by others throughout Northern ... a top-rated dental implant facility in San Francisco,”explained Dr. ...
(Date:3/26/2015)... 26, 2015 Innovative research and ... and preventing often fatal ruptures, says The Bee ... raising awareness of brain aneurysms and funding innovative ... captured national attention with the death of ... died last Friday after suffering a ruptured brain ...
(Date:3/26/2015)... The National League for Nursing, ... , has announced its partnership with Questionmark®, a ... corporations to accurately and securely measure knowledge, skills, ... Utilizing Questionmark’s state-of-the-art software and a custom-built portal, ... delivery of the seventy-five to one hundred thousand ...
Breaking Medicine News(10 mins):Health News:Certified Culinary Medicine Specialist Program Jointly Launched by Goldring Center for Culinary Medicine at Tulane University and Cardiometabolic Risk Summit 2Health News:Certified Culinary Medicine Specialist Program Jointly Launched by Goldring Center for Culinary Medicine at Tulane University and Cardiometabolic Risk Summit 3Health News:Morristown VNA Fundraiser to Honor Distinguished Community Members 2Health News:Bay Area Dental Implant Specialist, Dr. Alex Rabinovich Announces Regional Educational Strategy 2Health News:Bay Area Dental Implant Specialist, Dr. Alex Rabinovich Announces Regional Educational Strategy 3Health News:Research and Funding Are Keys to Raising Awareness and Ultimately Preventing Fatal Brain Aneurysm Ruptures 2Health News:Research and Funding Are Keys to Raising Awareness and Ultimately Preventing Fatal Brain Aneurysm Ruptures 3Health News:NLN Testing Services Announces Improved Delivery and Analytics Software and Newly Developed and Revised Exams 2
... , ... ... , , , ... ...
... patient records, funded by the Wellcome Trust, suggests that older ... GPs for investigation later than younger women. Researchers ... the General Practice Research Database (GPRD) and compared recorded diagnoses ... to see whether there was a difference in how older ...
... be linked to a slight rise in high blood pressure, ... drinkers can take heart from a series of studies presented ... , For example, coffee drinkers appear to have a lower ... indication that having a few cups every day increases the ...
... ... ... , , ... ...
... , ... ... ... ...
... in front of TV, computer linked to less bonding with ... -- Too much time in front of computers or televisions ... their parents and peers, a new study suggests. , The ... 15, who provided details about how they spent their free ...
Cached Medicine News:Health News:KV Pharmaceutical Subsidiary Pleads Guilty to Two Felonies Regarding Oversized Drugs 2Health News:KV Pharmaceutical Subsidiary Pleads Guilty to Two Felonies Regarding Oversized Drugs 3Health News:KV Pharmaceutical Subsidiary Pleads Guilty to Two Felonies Regarding Oversized Drugs 4Health News:Study finds delay in referrals for older women with ovarian cancer 2Health News:Study finds delay in referrals for older women with ovarian cancer 3Health News:Coffee Is Generally Heart-Friendly 2Health News:Coffee Is Generally Heart-Friendly 3Health News:2010 Caring Coalition Conference Welcomes Author Gail Sheehy 2Health News:2010 Caring Coalition Conference Welcomes Author Gail Sheehy 3Health News:Mylan Files Annual Report on Form 10-K for Year Ended Dec. 31, 2009 2Health News:Screen Time May Take a Toll on Kids' Relationships 2
(Date:3/26/2015)... -- According to a new market research ... Microwave, Cryoablation, Others), Department (Interventional Radiology, Surgery, Oncology), Application ... Global Forecasts to 2019", published by MarketsandMarkets, the Tumor ... growing at a CAGR of 11.50% by 2019. ... spread through 195 pages and in-depth TOC on "Tumor ...
(Date:3/26/2015)... March 26, 2015 Zimmer Holdings, Inc. (NYSE ... ® Advanced Bearing Technology with Vitamin E by ... published earlier this month reported that, at 96 million ... Advanced Bearing Technology featuring Vitamin E grafted highly crosslinked ... wear rate reduction of 95 percent, with no cracking, ...
(Date:3/26/2015)... 2015 Finesse Solutions annonce l,organisation de ... innovateurs, visionnaires et cadres de direction du secteur ... de deux jours proposée exclusivement sur invitation sera ... ville de San Francisco , ... d,un forum destiné aux leaders des sciences de ...
Breaking Medicine Technology:Tumor Ablation Market Worth $462.0 Million by 2019 2Tumor Ablation Market Worth $462.0 Million by 2019 3Tumor Ablation Market Worth $462.0 Million by 2019 4Zimmer Announces New Testing Milestone For Vitamin E Advanced Bearing Technology 2Zimmer Announces New Testing Milestone For Vitamin E Advanced Bearing Technology 3Finesse Solutions annonce l'événement Cellworld 2015 2
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: