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GlaxoSmithKline Statement Confirming alli Safety

Friday, September 18, 2009 General News J E 4
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PITTSBURGH, Aug. 25 The following is the GlaxoSmithKline statement in response to the FDA's Early Communication about the safety review of orlistat:

"GSK stands firmly behind the safety and efficacy of alli. Our primary priority is patient health, and we want people to know that there is no evidence that alli causes liver damage.

The FDA is reviewing data from suspected cases on liver injury associated with the use of orlistat/alli. Any routine assessment from a regulatory body does not mean that a risk or causal relationship exists.

alli is a 'non-systemically' acting medicine - it is minimally absorbed in the blood and works locally in the gastro-intestinal tract. There is therefore no obvious biological mechanism to suggest liver damage can occur with alli.

Liver changes can have many causes. People who are overweight and obese are predisposed to liver-related disorders.

The safety of consumers is of utmost importance to GSK. We continually monitor and evaluate reports of adverse effects associated with use of all of our products, including alli.

GSK regularly communicates with independent regulatory bodies and provides them with comprehensive safety data on our products. Orlistat, the active ingredient in alli, is the most-studied weight loss medicine, with safety established through 100 clinical studies involving more than 30 thousand patients."

FOR ACCESS TO EXPERT COMMENT: Malesia Dunn Malesia.a.dunn@gsk.com 412 200 3544 Corey Martin Corey.Martin@Edelman.com 212-642-7798 917-981-1117

SOURCE GlaxoSmithKline
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