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
May 16, 2016
Health Canada has issued new information concerning the use of canagliflozin (Invokana). To read the full report, visit Health Canada's website at www.hc-sc.gc.ca.
A previous advisory on canagliflozin. was issued on June 22, 2015. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Amputation: There may be an increased risk for lower leg or toe amputations in people taking this medication, especially if you are at high risk for heart disease. Good foot care is very important for people with diabetes. Contact your doctor as soon as possible if you notice symptoms of leg pain, poor circulation, bluish, cold skin, and poor hair or toenail growth.
Diabetic ketoacidosis: If blood sugar levels are too high (hyperglycemia), a condition known as diabetic ketoacidosis may occur. In this condition, your body starts to use body fat as fuel, eventually leading to a large concentration of acid in the blood stream. This can result in unconsciousness, coma or death. Your risk of developing diabetic ketoacidosis may be increased if you are on a low carbohydrate diet, drink a lot of alcohol, have a severe illness or infection, or have problems with your pancreas. There have been reports of diabetic ketoacidosis in people taking canagliflozin.
If you develop symptoms of diabetic ketoacidosis such as difficulty breathing, feeling very thirsty, vomiting, abdominal pain, nausea, loss of appetite, confusion, and unusual tiredness, seek urgent medical attention.
Dizziness: Some people taking canagliflozin may experience decreases in blood pressure. This occurs because the medication causes an increased amount of fluid, along with the glucose, to be removed from the body through the kidneys. These blood pressure drops could lead to dizziness, lightheadedness, and falls. This may occur when you shift your body position, such as rising from a sitting or lying position. If you experience this problem, try getting up more slowly. If it persists or if you faint, contact your doctor. Seniors and other individuals who are at risk of experiencing low blood pressure (e.g., dehydration, taking medications for high blood pressure) should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Fractures: There is a very small increase in the risk of bone fractures in people taking canagliflozin. If you are at risk of osteoporosis or are taking medications that may decrease the strength of your bones, 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.
Glucose control: When canagliflozin is taken along with other medications for diabetes, glucose levels may drop too far, causing confusion, cold sweats, cool and pale skin, headache, fast heartbeat, or weakness. Your doctor may suggest decreasing the dose of your other medications when you first start taking canagliflozin. If you take other medications for diabetes, 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.
Kidney function: Canagliflozin may cause a decrease in kidney function. If you have reduced kidney function or kidney 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.
Potassium levels: Increases in blood levels of potassium may occur when taking canagliflozin. This is more likely to happen to people who are taking other medications that prevent potassium from being removed from the body, or those who have moderately reduced kidney function. This doesn't often cause problems, but potassium levels should be monitored by your doctor. If you experience unexplained nausea, fatigue, muscle weakness or tingling sensations, contact your doctor.
Yeast infections: There is an increased risk of developing genital or vaginal yeast infections when taking canagliflozin as a result of increased glucose in the urine. This is more likely to occur for uncircumcised males and for people who have a history of yeast infections.
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 canagliflozin 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.
Children: The safety and effectiveness of this medication have not been established for children less than 18 years of age.
Seniors: Seniors are more likely to experience side effects with this medication and may require lower doses.