Navigation Links
Video: FDA States Consumers Should Continue to Use alli
Date:9/2/2009

PARSIPPANY, N.J., Sept. 2 /PRNewswire/ -- The following is an updated GlaxoSmithKline Consumer Healthcare statement in response to the FDA's Early Communication about the safety review of orlistat:

On August 24th the FDA reported that it is continuing its safety review of orlistat and liver-related serious adverse events.

To view the Multimedia News Release, go to: http://www.prnewswire.com/mnr/alli/39949/

It's important consumers know that alli is safe and effective and there's no evidence to suggest alli causes liver injury. In fact, the FDA has said that consumers should continue to use alli as directed.

Because orlistat is minimally absorbed in the blood and works locally in the gastro-intestinal tract, there is no obvious biological mechanism to suggest liver injury can occur with alli.

To put FDA's communication into perspective, there is a high prevalence of liver disease in people who are overweight. It is estimated that about 15-20% of obese people have liver injury due to excessive fat in the liver.[1] Additionally, in obese individuals, gradual weight loss can prevent injury or improve liver function.

The August 24th communication is part of FDA's current process of sharing information directly with consumers and healthcare professional related to the safety monitoring of marketed drug products. This does not mean that FDA has concluded that there is a risk.

Since orlistat first became available as a prescription medicine in 1998, more than 40 million people have used the drug. Of these, more than 6 million have used alli, the only FDA-approved over-the-counter weight loss product. The FDA identified two reports of liver injury out of the six million consumers who have used alli since its approval in 2007.

Orlistat, the active ingredient in alli, is the most-studied weight loss medicine. Its safety has been established through 100 clinical studies involving more than 30,000 patients.

GSK continues to proactively monitor the safety of orlistat and share all relevant information with regulatory agencies. Based on our comprehensive review of the safety data from preclinical and clinical, post-marketing safety surveillance, published literature as well as epidemiology data, we conclude that the data do not suggest that orlistat is causally related to liver injury.

We are actively working with the FDA to better understand the reports it has received. If you have concerns, you should talk to your doctor or pharmacist. For more information on the safety and efficacy of alli, please visit www.myalli.com and/or call 1-800-671-2554.

[1] Preiss, D., Sattar, N. Non-alcoholic fatty liver disease: An overview of prevalence, diagnosis, pathogenesis and treatment considerations. (2008) Clinical Science, 115 (5-6), pp. 141-150.

    FOR ACCESS TO EXPERT COMMENT:
    Malesia Dunn
    malesia.a.dunn@gsk.com
    412-200-3544

    Mechal Weiss
    mechal.weiss@edelman.com
    212-642-7731
    917-952-4807


'/>"/>
SOURCE GlaxoSmithKline
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Video: Renowned Health Expert Dra. Aliza Teams Up With Baby Looney Tunes To Promote Healthy, Happy Babies
2. Video: Life Insurance Awareness Month is the Ideal Time for an Insurance Review
3. Video: Physical and Mental Health of U.S. Warfighter Is Focus of Military Health Research Forum
4. Video: Project Runway Designer Launches New Online Video Series to Educate About Living with HIV and AIDS and Help Combat HIV Stigma
5. Video: New Insights Link Low HDL-Cholesterol and Elevated Triglycerides with Coronary Heart Disease and Microvascular Complications in Patients at Goal for LDL-Cholesterol
6. Video: HHS Launches Best Bones Forever!
7. Video: CVS/pharmacy and MinuteClinic Encourage Americans to Protect Themselves Early With a Seasonal Flu Shot
8. Video: RE-LY Trial Met Primary Outcome for Reducing Incidence of Stroke or Systemic Embolism in Non-valvular Atrial Fibrillation Patients
9. Video: Phase III Head to Head Trial Showed Ticagrelor Reduced Cardiovascular Death and Heart Attacks Over Clopidogrel in Acute Coronary Syndromes Patients
10. Video: AstraZeneca Traveling Exhibit Helps Americans Understand and Manage Bipolar Depression
11. Video: School Nurses Tackle Low Parental Awareness of Meningitis Via Comprehensive National Public Education Campaign
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/28/2016)... ... May 28, 2016 , ... May 26, 2016- In search of ... Challenge with theme event of “K Warriors” on June 4, 2016 at Ashbury Hotel ... The event is sponsored and hosted by Shaolin Institute and sanctioned by KSF (Kungfu ...
(Date:5/27/2016)... (PRWEB) , ... May 27, 2016 , ... More than ... so it is not surprising that bariatric surgery has received increased attention in recent ... explains. Of course, when it comes to weight loss, most people are familiar with ...
(Date:5/27/2016)... ... May 27, 2016 , ... W.S. Badger Co. Inc ., the maker ... been recognized as one of the best small businesses for new dads by Fatherly, ... nine small businesses providing progressive benefits to new parents on the organization’s 2016 ...
(Date:5/27/2016)... ... ... This campaign aims to provide a path to improved education and awareness ... change. , As nearly 795,000 Americans suffering from a new or recurrent stoke each ... an estimated 129,000 of these people dying from stroke, it’s become our nation’s fifth-leading ...
(Date:5/27/2016)... Texas (PRWEB) , ... May 27, 2016 , ... ... satisfying Army body fat composition regulations. This is the first time that Coolsculpting ... normally screened at least every six months to ensure they meet the prescribed body-fat ...
Breaking Medicine News(10 mins):
(Date:5/25/2016)... 2016  Granger Diagnostics today announced immediate availability of ... infections. This test ensures discovery of ALL bacteria, ... test requires only a simple swab of the wound ... G. Bostwick , MD, Chief Medical Officer, described ... "We are excited to make available, for the ...
(Date:5/24/2016)... -- Niederländische Chirurgen haben eine innovative ... erlaubt, ihre Expertise weltweit zu teilen und so ... mit einer Instant-Messaging-Funktion und der Möglichkeit, in einem ... Afrika, Asien und den USA ... Information und Weiterbildung   "MDLinking ...
(Date:5/24/2016)... CHRISTCHURCH, New Zealand , May 24, 2016 ... scanning and informatics solutions for the healthcare sector, has been ... the New Zealand Hi-Tech Awards 2016. Dr ... a fantastic acknowledgement for our team.  It,s really good to ... the burden healthcare internationally. Our products are used in 35 ...
Breaking Medicine Technology: