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Study finds adverse effects in treatment for primary sclerosing cholangitis
Date:8/19/2009

researchers. Patients treated with UDCA were more likely to suffer serious adverse effects from the therapy then those who did not receive treatment (63% vs. 37%). Previous studies projected UDCA to be a safe and beneficial therapy.

According to researchers, the Food and Drug Administration (FDA) approved a UDCA dose of 13-15 mg/kg/day for patients with primary biliary cirrhosis and those patients did not suffer more adverse effects when treated with higher doses of the drug up to 25 or 30 mg/kg/day. Pilot studies in PSC patients using doses ranging from 17-25 mg/kg/day did not have an increased risk of adversities. "The findings in our study were surprising and quite unanticipated," said Dr. Lindor. "It is unclear how a drug that has a reputation for such safety would have these paradoxical effects in this condition."

Researchers speculate that higher doses of UDCA allowed unabsorbed drug to enter the colon, modifying into hepatotoxic bile acids and recommend further evaluation of this theory. "At this time, UDCA in a dose of 25-30 mg/kg/day should not be used due to the increased risk to PSC patients," advises Dr. Lindor. "We hope a safe and effective therapy for patients with PSC will be developed, but high-dose UDCA cannot be recommended."


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Contact: Dawn Peters
medicalnews@wiley.com
Wiley-Blackwell
Source:Eurekalert

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