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:12/9/2016)... ... 2016 , ... "I had a terrible time trying to get my grandson ... if the nebulizer had a more child-friendly design, then children would be more likely ... patent-pending NEBY to avoid the need to deliver medication via a nebulizer mask. The ...
(Date:12/8/2016)... ... December 08, 2016 , ... After enjoying record-breaking attendance at ... for its 33rd Annual Issues & Research Conference, March 2-3, 2017, at ... the conference is “Persistent Challenges and New Opportunities: Using Research to Accelerate the ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... Management (MTM), adherence, and other pharmacist-delivered patient care services, has announced the promotions ... Eric Hoessel to vice president of sales. , Litsinger joined Mirixa in ...
(Date:12/8/2016)... ... ... Premier Fitness Camp (PFC) and The Chopra Center for Wellbeing announced today the launch ... world headquarters of Omni La Costa Resort & Spa in San Diego. , Chopra ... personal development, a healthy lifestyle, or mental and physical healing. The week-long wellness program ...
(Date:12/8/2016)... ... December 08, 2016 , ... STATEN ... been recognized for adherence to the highest standards of trauma, maternity, cancer and ... the center's president and CEO, Dr. Daniel Messina. , Among the recognitions, the ...
Breaking Medicine News(10 mins):
(Date:12/8/2016)... Australia Ophthalmic Lasers Market Outlook to 2022 Summary ... to 2022", provides key market data on the Australia ... of US dollars, volume (in units) and average prices ... and YAG Lasers. The report also provides company ... market segements, and global corporate-level profiles of the key ...
(Date:12/8/2016)... , Dec. 8, 2016  The global biosurgery ... 8.8% during the forecast period of 2016 to 2021. ... by 2021 from USD 18.21 billion in 2016. The ... rising incidences of sports related injuries and spinal problems, ... rising need of effective blood loss management. ...
(Date:12/8/2016)... , Dec. 8, 2016 KEY FINDINGS ... largest share of the market in 2016 and is ... can be attributed to a large number of surgical ... hold the largest share in the patient temperature management ... such as reducing loss of blood during surgeries, lowering ...
Breaking Medicine Technology: