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FDA states consumers should continue to use alli

Parsippany, NJ (September 2, 2009) - 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.

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