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 ard of Glaxo's Respiratory Medicines Development Center in Research Triangle Park, North Carolina.

Salmeterol is a key ingredient in Serevent and is combined with a steroid to make up Advair, both of which work by easing constriction in the lungs of asthma sufferers. Serevent and Advair together outsell competing asthma treatments as well as Glaxo's other products. The drugs' sales last year totalled 2.5 billion pounds (about $4.4 billion.
'"/>




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:


(Date:1/17/2017)... ... January 17, 2017 , ... A prescription medication bottle, ... the fourth Cradle to Cradle Product Design Challenge , the Cradle to ... series of six circular design challenges scheduled to run through early 2018. The challenges ...
(Date:1/17/2017)... Baltimore, MD (PRWEB) , ... January 17, 2017 , ... ... joined the firm as a Principal in its IT Advisory Services practice . ... in recent months as market demand for strategic IT guidance grows, and the practice ...
(Date:1/17/2017)... ... January 17, 2017 , ... The ... in Tyler, has announced the latest beneficiary of their thriving community involvement program. ... organization dedicated to fulfilling the dreams of terminally ill patients. Donations to this ...
(Date:1/17/2017)... ... January 17, 2017 , ... ... the Montclair State University’s Athletic Training Education program forged a relationship built upon ... Education Program, which is consists of both student members and certified members ...
(Date:1/16/2017)... ... , ... Gym Source, America’s leading retailer of premium residential and commercial fitness ... , “We are elated to be opening this new showroom,” explains Tom Richard, Chief ... clients a seamless and motivating shopping experience.” , Every fitness journey is unique, and ...
Breaking Medicine News(10 mins):
(Date:1/17/2017)... company that brought a full line of equine first aid kits ... of companion animal pet first aid kits.  EquiMedic USA ... developed two sizes of small pet first aid kits under the ... a small and a large companion pet first aid kit, this ... newcomer to working with small animals either. Corporate owners, mother and ...
(Date:1/17/2017)... ® Technologies, Inc. announces that the Journal ... of Vibration on Molar Distalization," a study that focused ... Bowman , this prospective, peer-reviewed clinical study concluded that ... speeds up molar distalization rates in the apex ... to move the upper molars into a normal, Class ...
(Date:1/17/2017)... -- Research and Markets has announced the addition of ... to their offering. ... The global fluoropolymer market in the healthcare industry to grow ... Global Fluoropolymer Market in the Healthcare Industry 2016-2020, has been ... experts. The report covers the market landscape and its growth prospects ...
Breaking Medicine Technology: