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Statin-Aspirin Combo Pack Approved by FDA


WebMD Health News

Date of approval: June 25, 2003

 

What is approved:The FDA has approved a new drug combination package called Pravigard PAC that combines two drugs commonly used to lower cholesterol and reduce the risk of heart attack and stroke, Pravachol (pravastatin sodium) and buffered aspirin.

Pravachol is part of a class of prescription medications known as statins that lower the amount of "bad" LDL cholesterol and raises the level of "good" HDL cholesterol.

Buffered aspirin helps keep the blood flowing smoothly and prevents potentially dangerous clots from forming in blood vessels that can lead to heart attack or stroke. It also contains another ingredient that helps prevent stomach upset frequently associated with regular aspirin.

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

 

Side effects: Possible side effects of the two drugs include muscle damage, liver damage, bleeding and stomach problems. Users are urged to tell their doctors if they experience any of the following:

 

  • Unexplained muscle pain or weakness;
  • Unusual bleeding;
  • Heartburn;
  • Nausea or vomiting;
  • Stomach pain;
  • Bowel movements or stools that look like black tar.

 

Precautions:Pravigard PAC should not be taken by people 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.

Tests to check liver function may also be performed prior to use of Pravigard PAC.

Basis of approval: The drugs contained in Pravigard PAC are already approved for use in reducing the risk of heart-related events, such as heart attack, stroke, and death. People using cholesterol-lowering drugs, such as statins, should also eat a low-cholesterol diet.

In approving the new combination packaging, the FDA indicated that, "this co-packaged product may be more convenient for some patients."

Manufacturer: Bristol-Myers Squibb Company of Princeton, N.J.

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