Defecetive Drugs: adrugrecall.com
NEWS
- Accutane
- Advair
- Androstenedione
- Ativan
- Avandia
- Baycol
- Bextra
- Celebrex
- Cold-Eeze
- Crestor
- Ephedra
- Fen-Phen
- Lariam
- Lamisil
- Lipitor
- Meridia
- Naproxen
- Neurontin
- Ortho Evra
- OxyContin
- Palladone
- Paxil
- PPA
- Protopic
- Prozac
- Redux
- Reglan
- Rezulin
- Remicade
- Risperdal
- Serevent
- Seroquel
- Serzone
- Trasylol
- Viagra
- Vioxx
- Zicam
- Zoloft
- Zyprexa
Sign up for our newsletter
to receive breaking news about drugs to watch
This is a test of the new blog
network section on a drug recall.
Find A Lawyer
Near You
Contact us today for a complimentary consultation with a qualified attorney near you.
Serevent Risk Controversy
Serevent Risk Controversy
October 31 , 2005
In early October 2005, the consumer watchdog group, Public Citizen, accused GlaxoSmithKline of manipulating safety data to make it seem that Serevent is safer than it really is. This accusation appears in the October publication of The Lancet, a British medical journal. The Serevent controversy surrounds the SMART study, originally designed to measure the effects of Serevent on patients using this adjunct therapy for long term treatment of asthma and chronic obstructive pulmonary disease. During this trial, researchers found a small, but fatal, side effect risk associated with Serevent use. Public Citizen's Health Research Group says Serevent's makers downplayed and distorted the risk of these fatal side effects to make Serevent appear safer than it is.
GlaxoSmithKline adamantly denies this accusation, stating that the company, "communicated with a sense of urgency to ensure that healthcare professionals and patients had access to the results of the study as they became available." Serevent (salmeterol) and its chemical cousin Advair (salmeterol and steroid) currently carry a black box warning (the strongest caution short of a recall) about the fatal risks associated with these medications. The Health Research Group, which tells consumers not to use Serevent at all, says these warnings are not enough.
The SMART trial was designed as a 28-week study of Serevent. According to the Health Research Group, GlaxoSmithKline mixed in data from six months after the trial ended when submitting their final study results to the FDA in April 2003. These additions were intended to make the fatal risks associated with Serevent appear lower than they were during the trial. "In each case, the addition of the post-study data noise reduced the apparent risk of the drug," says the Health Research Group.
During the SMART clinical trial, 13 Serevent patients died, four times the number of study participants not taking this drug. During the six months after the trial, 15 Serevent patients died, 2.5 times the number of placebo patients. GlaxoSmithKline maintains that the company was forthright about the data and did not intentionally try to mislead the FDA or the public. Officials for the consumer rights group say, "This is not a drug patients should be using. There are short-acting beta agonists that are effective that have not been associated with increased mortality.This is consistent with previous findings about other long-acting beta agonists."
For more information on Serevent concerns, please contact us.
