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 Febuxostat.
HEALTH CANADA ADVISORY
November 4, 2019
Health Canada has issued new information concerning the use of febuxostat. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Conditions causing increased uric acid formation: Febuxostat is not intended to decrease uric acid levels for people with medical conditions causing increased uric acid formation (such as cancer or Lesch-Nyhan syndrome). If you have such a condition, discuss with your doctor how Febuxostat may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Febuxostat, and whether any special monitoring is needed.
Gout: Do not start febuxostat treatment until an acute attack of gout has completely subsided, as further attacks may be brought on by Febuxostat. Acute gout attacks may be brought on at the start of treatment with febuxostat for people who have not used Febuxostat before. If an acute gout attack develops after starting Febuxostat, call your doctor.
Heart Attack: Studies indicate that people taking Febuxostat may have an increased risk of heart attack and strokes. In a recent study, people taking febuxostat who also had heart disease, were found to be at an increased risk of heart-related deaths. If you experience signs of a heart attack, such as discomfort or pain in the chest, back, neck, jaw, arms, or stomach; difficulty breathing; sweating; nausea; lightheadedness or the feeling of impending doom contact your doctor or get medical attention immediately. People with Angina or congestive heart disease should not use Febuxostat.
Kidney function: If you have Kidney Disease or reduced kidney function, discuss with your doctor how Febuxostat may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Febuxostat, and whether any special monitoring is needed.
Lactose intolerance: Febuxostat contains lactose. If you have galactose intolerance (galactosemia, glucose-galactose malabsorption, or Lapp lactase deficiency) you should not take Febuxostat.
Liver function: Febuxostat may reduce liver function and can cause liver failure. Your doctor may perform regular tests to check your liver function. If you have liver problems, discuss with your doctor how Febuxostat may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Febuxostat, and whether any special monitoring is needed.
If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Skin rash: If you develop a skin rash, stop taking Febuxostat and contact your doctor. The skin rash may be the first sign of a serious reaction to Febuxostat.
Stroke: Studies indicate that people taking Febuxostat may have an increased risk of heart attacks and strokes. If you experience signs of a stroke, such as confusion, difficulty speaking, loss of coordination, sudden headache or vision changes, contact your doctor or get medical attention immediately.
Pregnancy: Febuxostat should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Febuxostat, contact your doctor immediately.
Breast-feeding: It is not known if febuxostat passes into breast milk. If you are a breast-feeding mother and are taking Febuxostat, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using Febuxostat have not been established for children.
