Medsafe alert on Xenical liver risk

Medicine watchdog Medsafe will keep a close eye on an American investigation into the weight-loss drug Xenical after reports it may cause liver damage.

The United States Food and Drug Administration is reviewing the safety of orlistat marketed under the brand names Xenical and Alli Of 32 reports the agency received between 1999 and last year, 27 patients required admittance to hospital.

The UK's Medicines and Healthcare products Regulatory Agency has received 137 reports of suspected liver damage from orlistat users since the drug was licensed in 1998.

No definite association has been made yet between liver injury and orlistat and the FDA has told users they can continue to take the medicine in the meantime.

Medsafe group manager Stewart Jessamine said there had been no reports in New Zealand of serious liver injury linked to orlistat, but Medsafe would "watch carefully" for the FDA investigation results and then evaluate the need for any safety action.

However, anyone taking Xenical should get medical advice if they had symptoms associated with liver injury, such as fever, jaundice, dark brown urine, nausea, vomiting, itching, weakness or fatigue, he said.

John Wyeth, a Wellington gastroenterologist, said he had not come across cases of liver damage that seemed to be caused by Xenical.

It would be difficult to confirm a link, he said. "If you're taking Xenical, you must be obese and obesity causes abnormal liver function on its own."

Xenical, which works by stopping the body absorbing fat, has been available in New Zealand by prescription since 1998 and from a pharmacist since 2005.