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Weight-loss drugs under review

The US FDA is reviewing reports of serious liver injury in patients taking Roche's Xenical or GSK's over-the-counter version, alli

The US Food and Drug Administration (FDA) is reviewing reports of serious liver injury in patients taking Roche's Xenical or GlaxoSmithKline's (GSK) over-the-counter version, alli.

Thirty-two reports were received between 1999 and 2008 of serious liver injury in patients taking the weight-loss drug, known generically as orlistat. All but two of the cases occurred outside the US. Twenty-seven patients were hospitalised and six cases resulted in liver failure. The most commonly reported adverse effects included jaundice, weakness and stomach pain.

The FDA stated that it is reviewing additional information supplied by the manufacturers and that "no definite association between liver injury and orlistat has been established at this time." People who are taking the drug should continue to use it as directed, the agency added.

GSK said: "There is no evidence that alli causes liver damage which can stem from many causes. People who are overweight or obese are predisposed to liver-related disorders."

At time of press, no comment had been received from Roche.

25th August 2009

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