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FDA Approves Pravigard PAC (Buffered Aspirin and Pravastatin Sodium) Tablets For Those At Risk Of Heart Disease, Heart Attack, Or Stroke

PRINCETON, NJ -- June 25, 2003 -- Bristol-Myers Squibb Company (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has approved Pravigard™ PAC (Buffered Aspirin and Pravastatin Sodium) tablets. Pravigard PAC contains two widely used medications -- Pravachol® (pravastatin sodium) tablets and buffered aspirin tablets -- co-packaged with each daily dose side-by-side. In patients for whom treatment with both Pravachol and Buffered Aspirin is appropriate, Pravigard PAC is indicated along with diet to reduce the occurrence of cardiovascular events, including death, heart attack or stroke in patients who have heart disease. In these patients, Pravigard PAC can lower the chances of dying of heart disease or having a heart attack or stroke.

"Bristol-Myers Squibb is committed to developing therapy options that may help patients manage their medications," said Peter R. Dolan, chairman and chief executive officer, Bristol-Myers Squibb. "As a leader in the field of cardiology, Bristol-Myers Squibb is pleased to provide physicians and patients with a new product that can reduce patients' risk of suffering a second heart attack or stroke."

To provide prescribers with dosing flexibility, Pravigard PAC will be available in different dosage combinations. The recommended daily dose of Pravigard PAC is 40 mg of Pravachol(R) (pravastatin sodium) with either 81 mg or 325 mg of buffered aspirin. Pravigard(TM) PAC is also available with 20 mg or 80 mg of Pravachol packaged with either 81 mg or 325 mg of buffered aspirin.

Pravigard PAC, available by prescription only, is not for everyone including women who are pregnant or nursing or may become pregnant, people with liver or kidney problems, asthma or nasal polyps, children younger than 18 years of age, people who are allergic to medicines called "nonsteroidal anti-inflammatory drugs" (NSAIDs) or to any of the ingredients in Pravigard PAC, including aspirin. Before and during Pravigard PAC therapy, patients should tell their doctor if they drink three or more alcoholic drinks every day, if they have bleeding problems or stomach problems (such as heartburn, upset stomach or ulcers) that are new or won't go away and about any other medications they are taking. Because serious side effects can result, patients should tell their doctor about any unexplained muscle pain or weakness they experience while on Pravigard PAC. Doctors may do blood tests to check for liver problems. The most common side effects with Pravigard PAC are rash, stomach pain, upset stomach, muscle ache and headache.

For full prescribing information for Pravigard(TM) PAC (Buffered Aspirin and Pravastatin Sodium) tablets, please contact Julie Keenan at 609-252-3732 or visit http://www.pravigardpac.com.


SOURCE: Bristol-Myers Squibb Company

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