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FDA approves first co-packaged treatments to reduce occurrence of serious cardiovascular and cerebrovascular events

ROCKVILLE, MD., June 25, 2003 -- The FDA has announced the approval of Pravigard PAC (co-packaged pravastatin sodium and buffered aspirin tablets) for use when treatment with both Pravachol (pravastatin) and buffered aspirin is appropriate. This co-packaged product may be more convenient for some patients.

Pravachol and buffered aspirin are both indicated to reduce the occurrence of cardiovascular events, including death, myocardial infarction or stroke, in patients who have clinical evidence of cardiovascular and/or cerebrovascular disease. Patients receiving treatment with Pravigard should also be placed on a standard cholesterol-lowering diet.

Pravachol is a prescription medication that both lowers the amount of "bad" (or LDL) cholesterol and raises the amount of "good" (or HDL) cholesterol. High cholesterol levels can lead to plugs or clots in blood vessels.

Buffered aspirin stops the normal blood clotting process and keeps clots from forming in blood vessels that can lead to myocardial infarctions or strokes. Buffered aspirin has aspirin in it along with other ingredients that may lower patients' chances of getting an upset stomach.

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 non-steroidal anti-inflammatory (NSAID) medicines or any of the ingredients in Pravigard PAC.

Possible serious side effects associated with the use of Pravigard PAC include muscle damage, liver damage, bleeding and stomach problems. It is therefore important for patients taking Pravigard PAC to tell their doctors if they experience any of the following: 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 the initiation of Pravigard PAC.

The usual dose of Pravigard PAC is 1 aspirin tablet with 1 Pravachol tablet once a day. Pravigard PAC is available in cartons containing either 30 buffered aspirin 81mg or 325mg tablets packed with either 30 Pravachol 20mg, 40mg or 80mg tablets.

The Bristol-Myers Squibb Company is the sponsor of the approved New Drug Application (NDA) for Pravigard PAC.

Source: FDA

Posted: June 2003