“Diet drug investigated after 32 users suffer liver damage
By Mail Foreign Service
Last updated at 6:00 PM on 25th August 2009
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A pharmacist holds a pack of Alli at a chemists in London. The drug has been linked to liver damage
A popular diet drug is being investigated by American health officials after reports that it could cause serious liver damage.
Alli, which went on sale in Britain in April, is the only weight loss drug available without a prescription.
The US Food and Drug Administration is looking into 32 reports of liver damage in patients taking Alli and Xenical, the drug’s prescription version.
The reports, submitted between 1999 and October last year, are mostly from outside America. Twenty-seven patients were admitted to hospital and six suffered liver failure
A spokesman for GlaxoSmithKline, which sells Alli, said overweight or obese people are predisposed to liver related disorders, and ‘there is no evidence that Alli causes liver damage’.
He added that the drug works in the gastrointestinal tract and so there was ‘no obvious biological mechanism that would suggest liver damage can occur’.
An FDA spokesman said: ‘No definite association between liver injury and orlistat [the generic name for the drug] has been established.’
He added that those taking the drug should continue to use it as directed.
Glaxo sold £56 million worth of Alli in the EU between April and June. Analyst Mike Krensavage, head of Krensavage Asset Management, said:
‘Any time the FDA raises an issue like this, demand is likely to suffer, at least temporarily.’
He added that the drug reduces weight only slightly, adding: ‘If there’s a minimal benefit, risks perhaps take more of a toll on sales.’
The 30 outside the US who had liver damage were taking- milligram doses of Xenical, the FDA said.
The two US cases were associated with Alli, half the strength of the prescription dose.
Orlistat users should see a doctor if they suffer fever, jaundice or brown urine, the FDA said.
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