HEALTH CANADA ADVISORY
February 4, 2014
Health Canada has issued new restrictions concerning the use of fosinopril. 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.
Angioedema: Angioedema, a serious allergic reaction that causes the area around the throat and tongue to swell, that may occur with use of fosinopril. If you experience swelling of the face, tongue, or throat, stop taking fosinopril at once and get immediate medical attention. Other medications in the class of medications known as ACE inhibitors should not be taken in the future. People who have had angioedema caused by other substances may be at increased risk of angioedema while receiving an ACE inhibitor.
Blood counts: This medication can decrease the number of neutrophils (a type of white blood cell that helps fight infection), red blood cells (which carry oxygen), and platelets (which help your blood to clot). Your doctor will do blood tests to monitor this. If you notice any signs of infection (e.g., fever, chills, or sore throat) or unusual bleeding or bruising, contact your doctor immediately.
Cough: People taking fosinopril may develop a dry, persistent cough that usually disappears only after stopping or lowering the fosinopril dose. Be sure to tell your doctor of any cough that does not seem to be related to a usual cause.
Fluid and electrolyte balance: In rare cases, people who take fosinopril experience an increase in blood levels of potassium. This rarely causes problems, but potassium levels should be monitored by your doctor.
Kidney function: Changes in kidney function have been seen for certain people who take this medication (e.g., people with narrowed blood vessels in their kidneys, or those with severe congestive heart failure). The use of diuretics (water pills), aliskiren or nonsteroidal anti-inflammatory drugs (NSAIDs) may further increase risk of kidney problems for people already at risk for this problem. If you have 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.
Liver function: This medication may worsen liver function. If you have liver disease or poor 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.
If you notice any signs of liver problems (e.g., abdominal pain, itching of skin, yellow eyes or skin, loss of appetite, vomiting), contact your doctor immediately.
Surgery: Anaesthetics and pain relievers used during can cause decreased blood pressure. Fosinopril may make the decrease in blood pressure worse. Make sure that your health care team knows you are taking this medication.
Low blood pressure: Occasionally, blood pressure drops too low after taking fosinopril. This usually happens after the first or second dose or when the dose is increased. It is more likely to occur for those who take aliskiren or water pills, have a salt restricted diet, are on dialysis, are suffering from diarrhea or vomiting, or have been sweating excessively and not drinking enough liquids. If low blood pressure causes you to faint or feel lightheaded, contact your doctor.
Pregnancy: ACE inhibitors such as fosinopril may cause severe harm or death to the developing baby if taken by the mother during pregnancy. This medication should not be used during pregnancy. If you discover you are pregnant, stop taking fosinopril at once and contact your doctor.
Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking fosinopril, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of fosinopril for children have not been established. Its use by this age group is not recommended.