Roche defends diet drug as FDA probes liver claim

There is no evidence of a link between weight loss drug Xenical and liver injury, drugmaker Roche said on Tuesday.

United States health officials are reviewing reports of liver injury in people who took Xenical or the over-the-counter version of the drug sold by GlaxoSmithKline under the brand name alli.

The Food and Drug Administration (FDA) said on Monday it had received 32 reports between 1999 and 2008 of serious liver injury in patients taking the drug, which is known generically as orlistat.

”Roche has continually monitored and analysed the hepatic [liver] safety of Xenical. Up to now, there is no evidence of a link between Xenical and liver injury,” spokesperson Alexander Klauser said in a statement.

Neither treatment is a major revenue driver for Glaxo or Roche.

”Since Xenical is only to a minimal extent systemically absorbed, there is no obvious mechanism to explain hepatoxicity. However, we take patient safety very seriously and continue to work closely with the FDA,” Klauser said.

The safety of Xenical has been shown by more than 100 clinical studies including more than 30 000 patients, he added.

Glaxo also said late on Monday there was no evidence their drug caused liver damage. — Reuters

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