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
January 24, 2013
Health Canada has issued new restrictions concerning the use of pravastatin. 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.
Diabetes: Pravastatin may cause an increase in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.
If you have diabetes or are at risk for developing 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.
Diet: Pravastatin is not intended to be used alone to reduce high cholesterol levels. It is important that a cholesterol-reducing diet along with appropriate exercise be attempted before taking any medication and continued while taking medication.
Grapefruit Juice: Tell your pharmacist or doctor if you regularly drink grapefruit juice, because grapefruit juice may interact with pravastatin.
Kidney problems: If you have decreased kidney function or a history of 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: Pravastatin may reduce liver function and can cause liver failure. Laboratory signs of harmful effects to the liver occur in about 0.5% of adults who take pravastatin for extended periods. When the medication is stopped, the laboratory tests usually slowly return to normal.
Your doctor may want to test your liver function regularly with blood tests while you are taking this medication. This medication should not be used by people with active liver disease or by people whose liver function tests are higher than normal. If you have a history of liver 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.
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.
Muscle effects: In rare cases, serious muscle damage been associated with the use of statin medications (i.e., cholesterol-lowering medications 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 medications, including prescription, non-prescription and natural health products, as drug interactions are possible
- are taking other cholesterol-lowering medication such as fibrates (gemfibrozil, fenofibrate) or niacin
- do excessive physical exercise
- have diabetes
- have a family history of muscular disorders
- have kidney or liver problems
- have thyroid problems
- have undergone surgery or other tissue injury
- have had any past problems with the muscles (pain, tenderness), after using a statin
- regularly drink three or more alcoholic drinks daily
Report any unexplained muscle pain, tenderness, weakness, 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: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, stop taking it immediately and contact your doctor.
Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking pravastatin, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: There is limited experience with the use of this medication by children. The safety and effectiveness of using this medication have not been established for children under 16 years of age.
Seniors: If you are older than 65 years of age, you will probably need to have regular liver tests while you are taking this medication.