Liver Damage Reports Put Alli Under Microscope

FDA says liver damage, liver failure reported in patients taking Alli, Xenical

By Ellen Goldberg
|  Monday, Aug 24, 2009  |  Updated 10:54 PM CDT
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FDA Investigates Popular Weight-Loss Drug

NBCDFW.com

The FDA is investigating 27 reports of liver damage and six cases of liver failure in patients taking Alli, a popular over-the-counter weight-loss drug, and its prescription version, Xenical.

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FDA Investigates Popular Weight-Loss Drug

The FDA is investigating reports of liver damage in people who take Alli and Xenical.
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The Food and Drug Administration is investigating reports of liver damage in people who take a popular weight-loss drug.

The agency is investigating 27 reports of liver damage and six cases of liver failure in patients taking Alli, a popular over-the-counter weight-loss drug, and its prescription version, Xenical.

“I think the FDA is clear that there is no definite association, but they are letting people know they are investigating it,” said Bernadette Latson, a registered dietician at UT Southwestern.

Latson said Alli and Xenical work by blocking the intestines from absorbing fat.

“It's not supposed to go in the blood stream, so it’s a surprise for sure,” she said.

For now, the FDA recommends patients continue taking the drug as directed.

”I think it's great the FDA notifies people so they can make an informed decision," Latson said.

A spokeswoman for the drug's manufacturer, GlaxoSmithKline, said there is no evidence the drug causes liver injury.

“Alli's safety has been studied in more 30,000 patients in 100 clinical studies," Debbie Bolding said in a statement.

She also noted that people who are overweight are predisposed to liver-related disorders.

Alli is the only over-the-counter weight-loss drug approved by the FDA.

“I have seen people that have had real results with it,” said Dallas pharmacist David Finch, who also uses the product. ‘”From what I’ve seen thus far, it's a good product.“

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