Weight-Loss Drug Alli Doesn’t Cause Liver Failure, Maker Says

GlaxoSmithKline PLC has come out swinging against the Food and Drug Administration, saying in a newly released statement that its over-the-counter weight-loss medication Alli does not cause liver failure or liver damage.

Earlier this week, the Food and Drug Administration announced it was investigating 32 reports of liver failure and injuries from users of Alli and the related drug, Xenical. Both drugs are based on orlistat, the drug at the center of the liver injury controversy.

Alli is the over-the-counter, lower-dose form of orlistat approved in the United States in 2007. Xenical, which is available only by prescription, contains a higher dose of orlistat and has been approved since 1999.

Both drugs are used along with low-fat and reduced-calorie diets to help people keep weight off, but concerns about liver failure have prompted questions about their safety and efficacy.

According to the FDA, in six of the reported cases, orlistat users suffered liver failure and in 27 cases, the patients had to be hospitalized for treatment of liver complications. Common symptoms of liver failure and liver disease include weakness, fatigue, stomach pain, and jaundice.

In Defense of Alli

Alli is seen as a key drug for GlaxoSmithKline, having reportedly earned the company $131 million in its first full year on the U.S. market. So it should come as no surprise that the company is pulling no punches in rushing to the defense of its prized product.

In a statement released the day after the FDA announcement, the drug company said there are many causes of liver damage, particularly in the overweight and obese who commonly take Alli. Also, the company alleged, there is no solid evidence pointing to Alli as a cause of the liver injury reports now being investigated by the FDA.

“Alli is a ‘non-systemically’ acting medicine – it is minimally absorbed in the blood and works locally in the gastro-intestinal tract,” the statement said. “There is therefore no obvious biological mechanism to suggest liver damage can occur with Alli.”

The FDA’s announcement, called an “Early Communication,” means the agency is still investigating the reports of patient injuries linked to orlistat drugs. There has been no word about what, if anything, the agency has concluded about the reports or what enforecement actions might be taken to improve patient safety in the future. No final decisions will be announced until the FDA wraps up its investigation, so we all just have to wait.

In the meantime, the FDA is advising patients taking Alli and Xenical to continue doing so, unless advised differently by their physician.

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