Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
December 5, 2011
Health Canada has issued new restrictions concerning the use of ursodiol. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Liver disease: Ursodiol is broken down by the liver. Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects and possibly worsen liver damage. If you have liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Monitoring: Your doctor should order monthly liver function tests for the first 3 months you are taking this medication, and every 6 months after that. Improvements in the results of these blood tests do not always mean that the disease is improving. Do not stop taking this medication without talking to your doctor.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if ursodiol passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
The safety and effectiveness of using this medication have not been established for children.