HEALTH CANADA ADVISORY
February 4, 2014
Health Canada has issued new restrictions concerning the use of aliskiren. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
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.
Blood electrolytes (salts): This medication may cause changes in electrolyte (e.g., potassium, sodium, chloride) levels in the blood. If you are taking other medications that affect electrolyte levels such as potassium supplements, certain diuretics (e.g., amiloride, triamterene), or salt substitutes containing potassium, 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. Contact your doctor if you experience symptoms of electrolyte imbalance such as dry mouth, muscle pain or cramps, tired muscles, low blood pressure, decreased urine production, fast heart rate, or nausea or vomiting while taking this medication.
Blood sugar: Hydrochlorothiazide can change blood glucose (sugar) levels in some people. If you have diabetes and are taking this medication, monitor your blood sugar levels closely and report any changes to your doctor.
Calcium: Hydrochlorothiazide can increase calcium levels in the blood. Your doctor will check your calcium levels regularly while you are taking this medication.
Cholesterol and triglycerides: Hydrochlorothiazide may increase cholesterol and triglyceride levels. Your doctor will monitor for this with blood tests.
Diabetes: People with type 2 diabetes may be at higher risk of side effects such as kidney problems, stroke, high potassium levels in the blood, and blood pressure that's too low. If you have type 2 diabetes, discuss with your doctor how this medication may affect your medical condition and whether any special monitoring is needed. If you have type 2 diabetes and are also taking certain high blood pressure-lowering medications, you should not take aliskiren - hydrochlorothiazide (see the "Who should not take this medication?" section). Talk to your doctor for more information.
Diarrhea: If you experience severe and persistent diarrhea while taking this medication, stop taking it and contact your doctor.
Glaucoma: Hydrochlorothiazide may cause a sudden reaction leading to glaucoma in some people. If you experience a sudden decrease in vision or pain in the eyes (usually within hours to a week of starting the medication), stop taking the medication and contact your doctor immediately.
Kidney problems: Aliskiren - hydrochlorothiazide can cause changes in kidney function. If you have reduced kidney function or a history of dialysis or other kidney problems (e.g., nephrotic syndrome), 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. People with severely reduced kidney function should not take this medication.
Liver function: This medication can cause changes in the amount of fluid and certain chemicals in the body. For people who have reduced liver function, these changes can cause severe problems for the liver. If you have reduced liver function, 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. People with severely reduced liver function should not take this medication.
Low blood pressure: This medication can cause low blood pressure, especially for people who are taking other diuretics (water pills), are receiving dialysis, or have lost fluid from diarrhea and vomiting. If you feel dizzy and lightheaded while taking this medication, lie down until these symptoms go away and contact your doctor.
Lupus: Hydrochlorothiazide can trigger or worsen lupus. If you experience symptoms such as fever, facial rash, or joint pain, or your lupus symptoms worsen while taking this medication, contact your doctor.
Other blood pressure medications: When combined with blood pressure medications in the angiotensin converting enzyme inhibitor (ACEI) family or the angiotensin receptor blocker (ARB) family, aliskiren has been linked to stroke, severely low blood pressure, and decreased kidney function. If you are taking a medication in either of these families, avoid taking aliskiren until you speak with your doctor or pharmacist.
Uric acid and gout: Hydrochlorothiazide may increase uric acid levels in the blood and cause gout. If you experience symptoms of gout such as a swollen, red, painful joint, contact your doctor immediately.
Pregnancy: This medication should not be used during pregnancy as it may cause serious birth defects or death. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: Hydrochlorothiazide passes into breast milk. It is not known if aliskiren passes into breast milk. If you are a breast-feeding mother and are taking aliskiren - hydrochlorothiazide, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication are unknown for children under 18 years of age.
Seniors: Seniors may be more sensitive to the effects of this medication.