Before you begin taking 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 take this medication.
HEALTH CANADA ADVISORY
January 24, 2013
Health Canada has issued new restrictions concerning the use of fluvastatin. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Alcohol: People who drink large quantities of alcohol should be closely monitored by their doctor while they are taking this medication.
Kidney disease: Fluvastatin is not recommended for people with severe kidney disease.
Liver effects: Lab tests show signs of harmful effects to the liver may occur for a small percentage of adults who take fluvastatin for long periods of time. When this medication is stopped, the laboratory tests usually slowly return to normal. If you take fluvastatin, your doctor will likely monitor your liver function. People with a history of liver disease should be closely monitored by their doctors while they are taking this medication.
Muscle effects: In rare cases, serious muscle damage been associated with the use of statin medications (i.e., cholesterol-lowering drugs whose names end in "statin," such as atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, or simvastatin), especially at higher doses. Before taking this medication, tell your doctor or pharmacist if you:
- are over the age of 70
- are taking other cholesterol-lowering medications such as fibrates (gemfibrozil, fenofibrate) or niacin
- are taking other medications, including prescription, non-prescription, and natural health products, as drug interactions are possible
- do large amounts of physical exercise
- have a family history of muscular disorders
- have diabetes
- have had any past problems with the muscles (pain, tenderness) after taking a statin
- have kidney or liver problems
- have thyroid problems
- have undergone surgery or other tissue injury
- regularly drink 3 or more alcoholic drinks daily
Report any unexplained muscle pain, tenderness, weakness or cramps, or any brown or discoloured urine to your doctor immediately, particularly if you are also experiencing malaise (a general feeling of being unwell) or fever.
Pregnancy: Fluvastatin should not be taken by pregnant women. If you become pregnant while taking fluvastatin, stop taking the medication immediately and contact your doctor.
Breast-feeding: It is not known whether fluvastatin passes into breast milk. Women taking fluvastatin should not breast-feed.
Children: There is limited experience with the use of this medication by children (under 10 years). The safety and effectiveness for children have not been established.
Seniors: If you are older than 70 years of age, your doctor will likely monitor you closely for muscle-related side effects.