Wednesday, September 23, 2009

Did diet drug damage liver?

RofecoxibImage via Wikipedia

A late post, but something to be aware of concerning some drugs…
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DRUG INVESTIGATION

WASHINGTON - Health officials in the United States are investigating reports of liver injury in patients who took weight-loss drug Xenical and its over-the-counter version Alli.

The Food and Drug Administration (FDA) said on Monday they have received more than 30 reports of liver damage in patients taking the drug, which is known as Orlistat. The reports, submitted between 1999 and October 2008, included 27 hospitalised patients, and six who suffered liver failure.

Alli and Xenical are both marketed by British drug-maker GlaxoSmithKline, though Xenical is manufactured by Swiss firm Roche.

The FDA says it has not established a direct relationship between the weight loss treatments and liver injury, and advised patients to continue using the drugs as directed.

"Consumers should consult their health care professional if they experience symptoms," the agency said on its website. Signs of liver damage include fatigue, fever, nausea and vomiting.

The FDA said it is reviewing additional details about the suspected cases of liver injury submitted by manufacturers.

Roche referred questions to GlaxoSmithKline.

A spokeswoman for GlaxoSmithKline said there is no evidence the company's drug causes liver injury, noting that it primarily acts on the intestinal tract. She said Alli's safety has been studied in more 30,000 patients enrolled in 100 clinical studies.

"Liver changes can have many causes," said Ms Debbie Bolding, in a statement. "People who are overweight and obese are predisposed to liver-related disorders."

The FDA first approved Xenical in 1999 and Alli in 2007. The prescription pill is twice as potent as Alli.

In general, the FDA has started notifying the public earlier about possible safety issues with drugs, after coming under fire for acting too slowly on problems with blockbuster treatments like Merck's painkiller Vioxx. AGENCIES

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RELATED NEWS:

Singapore HSA is monitoring Xenical probe

Singapore has two products containing Orlistat: Xenical which is prescription-only and the Xenical which can be dispensed under the supervision of a registered pharmacist.

Since 2000, the Health Sciences Authority has received four adverse reaction reports here that are suspected to be linked to Orlistat.

While two involved liver injuries, the link between the injuries and the weight loss drug could not be "conclusively established due to incomplete information and presence of confounding factors", said a spokeswoman.

Singapore has two products containing Orlistat: Xenical which is prescription-only and the Xenical which can be dispensed under the supervision of a registered pharmacist.

HSA said it will monitor the US FDA's investigation closely.

Meanwhile, patients may continue with the medication as directed by their doctors. But they should seek medical attention if they experience fever, fatigue, jaundice or nausea.

A spokeswoman for Roche said the company will continue distributing Xenical in Singapore: "Roche takes the issues of safety seriously and will continue to work with the health authorities closely."

ALICIA WONG

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Taken from TODAY, Health – Wednesday, 26-Aug-2009