The Department of Health (DH) today (December 6) alerted healthcare professionals and patients on ursodeoxycholic acid containing drugs to possible increase in serious liver adverse events as a result of taking an unapproved dose of ursodeoxycholic acid equivalent to twice the maximum recommended dose.
Through its surveillance system, DH noted that Health Canada had alerted healthcare professionals and consumers to an increase in serious liver adverse events. It was found that the patients' risk was 2.1-fold greater for death and liver transplantation in the treatment group of primary sclerosing cholangitis (PSC) taking twice the recommended dose of ursodeoxycholic acid against the patients treated with placebo.
A spokesman for DH explained that ursodeoxycholic acid containing drugs are used to treat conditions such as cholesterol gallstones and primary biliary cirrhosis. The recommended dose is 6-15 mg/kg/day for adults.
"Based on the information obtained so far, DH conducted risk assessment and considered patients should not take ursodeoxycholic acid containing drugs exceeding the indicated doses. They should seek medical assistance if feeling unwell or in doubt during treatment," he said.
"Healthcare professionals should be aware of the risks on patients if they take doses exceeding the recommended doses. Improved serum liver tests do not always correlate with improved liver disease status. They should monitor their patients' conditions closely," the spokesman continued.
There are 10 over-the-counter products containing ursodeoxycholic acid registered in Hong Kong. Eight of them contain ursodeoxycholic acid as single ingredient. So far, no adverse drug reaction report has been received.
The DH will issue a letter to healthcare professionals, to alert them to the possible risks associated with the drugs.
"The above finding will be discussed in the Registration Committee meeting of the Pharmacy and Poisons Board.
"The DH will also closely monitor related developments both locally and worldwide," the spokesman said.
(Reprinted from HKSAR Government web page
http://www.info.gov.hk/gia/general/201112/06/P201112060365.htm )