United States of America - The Food and Drug Administration (FDA) has approved Pravigard PAC® (co-packaged pravastatin sodium and buffered aspirin tablets) for use when treatment is appropriate. Pravachol and buffered aspirin are indicated for reducing the occurrence of cardiovascular events, including death, myocardial infarction or stroke in patients with clinical evidence of cardiovascular and/or cerebrovascular disease. Patients should also be placed on a standard cholesterol-lowering diet.

Pravigard PAC® should not be taken by patients who have certain liver or kidney problems, women who are pregnant or planning to become pregnant, individuals less than 18 years of age or by individuals who are allergic to nonsteroidal antiinflammatory (NSAID) medicines or any of the ingredients in Pravigard PAC®.

Possible serious side effects include muscle or liver damage, bleeding and stomach problems. Patients should report unexplained muscle pain or weakness, unusual bleeding, heartburn, nausea or vomiting, stomach pain or bowel movements or stools that look like black tar. Liver function tests may be performed prior to initiation of treatment.

Reference: FDA Talk Paper, T03-51, 25 June 2003