OTTAWA, 5 DEC — A drug used to treat some types of liver disease has been found to cause serious side-effects in certain patients, manufacturers of the medication said Monday in a joint advisory with Health Canada.
Ursodiol is also called ursodeoxycholic acid. Sold by several pharmaceutical companies under a variety of brand names, the drug is used to treat patients with a liver disease known as primary sclerosing cholangitis
.
Sclerosing cholangitis is a condition marked by swelling, scarring and destruction of the bile ducts inside and outside the liver. The disease may occur in patients with other conditions, including autoimmune disorders, chronic pancreatitis and inflammatory bowel disease (Crohn's or ulcerative colitis).
In a clinical study, patients given twice the recommended dose of ursodiol had improved serum liver test results, but overall had more serious adverse events -- including swollen veins of the digestive tube, the need for a liver transplant, or death -- compared with patients given a placebo.
Primary sclerosing cholangitis may also be associated with these serious events during progression of the disease.
Patients should not stop taking the medication or modify treatment without medical advice, and the manufacturers advise patients to discuss treatment with their health-care provider during their next visit.
vvWhile improved liver tests do not always mean that the disease itself has improved, it is still recommended that patients be monitored using blood liver tests every month for three months after starting ursodiol, then every six months. Treatment should be stopped if test results worsen.
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