GSK Consumer Healthcare to Update alli Label as FDA Completes Safety Review of Orlistat
PARSIPPANY, N.J., May 26 /PRNewswire/ -- GSK Consumer Healthcare
today announced it will update the alli product label to alert
consumers to certain symptoms that have been associated with rare
instances of severe liver injury reported in people taking
orlistat, the active ingredient in alli. This update follows FDA's
completion of its safety review of orlistat and is being
implemented in conjunction with Roche, the manufacturer of the
prescription dose of orlistat (Xenical). The agency stated that a
cause and effect relationship has not been established.
The updated alli label will advise consumers to: "Stop use and
ask a doctor if you develop itching, yellow eyes or skin, dark
urine or loss of appetite. There have been rare reports of liver
injury in people taking orlistat."
"GSK is committed to ensuring that consumers and physicians
understand the safety profile of orlistat and alli. Although
reports of serious liver injury in people taking orlistat are rare,
GSK takes all adverse events reports seriously. Reaching and
maintaining a healthier weight is one of the most important things
people can do for their health. GSK wants people to have the
information they need to choose the right weight loss aid for their
situation," said Howard Marsh, M.D., Chief Medical Officer for GSK
Consumer Healthcare.
alli is the only FDA-approved over-the-counter weight loss aid.
Since alli was made available over-the-counter in 2007, more than
10 million people worldwide have used the product. With more than
100 clinical studies involving 30,000 patients, orlistat is the
most extensively studied weight loss drug in the world and
continues to be a safe and effective product when used as directed
to help people lose weight. More than 40 million people have used
orlistat since it first became available in 1998.
For more information about the safety and efficacy of alli,
consumers and health care professionals may call 1-800-671-2554 or
visit www.myalli.com.
About alli
alli is the only FDA-approved weight-loss product available to
overweight adults, 18 years or older, without a prescription. It
combines a clinically-proven product with a comprehensive
individualized action plan. People who use alli can lose 50 percent
more weight than diet alone. The alli program encourages gradual
weight loss, known by experts as the best way to lose weight. alli
(60 mg orlistat capsules) is safe and effective when used as
directed.
About GlaxoSmithKline Consumer Healthcare
GlaxoSmithKline Consumer Healthcare is one of the world's
largest over-the-counter consumer healthcare products companies.
Its more than 30 well-known brands include the leading smoking
cessation products, Nicorette®, NicoDerm® CQ and
Commit® as well as Abreva® and many medicine cabinet
staples, including, Aquafresh®, Sensodyne,® Tums® and
Breathe Right®.
About GlaxoSmithKline
GlaxoSmithKline -- one of the world's leading research-based
pharmaceutical and healthcare companies -- is committed to
improving the quality of human life by enabling people to do more,
feel better and live longer. For company information visit:
http://www.gsk.com/.
Contacts: Deborah G. Bolding
GlaxoSmithKline Consumer Healthcare
973-889-2344 (office)
deborah.g.bolding@gsk.com
Source: GSK Consumer Healthcare
CONTACT: Deborah G. Bolding, GlaxoSmithKline Consumer
Healthcare,
+1-973-889-2344 (office), deborah.g.bolding@gsk.com
Web Site: http://www.gsk.com/
Posted: May 2010
