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| |  FDA Proposes Professional Labeling for New Lifesaving Benefit of Aspirin MORRISTOWN, N.J. June 13, 1996 -- The Food & Drug Administration (FDA) has proposed professional labeling for a new lifesaving benefit of aspirin: to reduce the risk of death during a suspected heart attack. This extended labeling means hope for over one million Americans each year, as heart attack is the nation's number one killer. This is further evidence that aspirin is truly a wonder drug. Not only is it unsurpassed in pain relieving benefits, but it continues to exhibit new uses that can save lives. This proposed labeling is the first of many new uses for aspirin under consideration by the FDA. The results of extensive clinical trials -- many using BAYER(R) Aspirin -- prove that in addition to its current professional use in the prevention of recurrent heart attack and the prevention of stroke in men after a TIA (transient ischemic attack or "mini-stroke"), aspirin is effective in reducing the risk of death during a suspected heart attack. Research shows that, under a physician's supervision, as little as one-half (162.5 mg) of a regular strength aspirin administered as soon as a heart attack is suspected and continued for 30 days significantly reduces the risk of death from a heart attack. BAYER(R) Aspirin was used in the landmark second International Study of Infarct Survival (ISIS-2), that was the basis for the proposed labeling and involved 17,187 patients with acute myocardial infarction (AMI) at 417 hospitals around the world. "Approximately 1.2 million heart attack patients are admitted to U.S. hospitals each year," said Charles Hennekens, MD, John Snow professor of medicine at Harvard Medical School, chief of preventive medicine at the Brigham and Women's Hospital and lead U.S. investigator of ISIS-2. "If we could increase aspirin use to virtually all patients having a heart attack, tens of thousands of premature deaths could be avoided each year in the U.S. alone." To help medical professionals put this new use for aspirin into action and save lives, Bayer Corporation will donate 100 unit dose packets of two BAYER(R) Chewable 81 mg Aspirin to more than 6,000 acute care hospitals in the United States. This year alone, as many as 1.5 million people will suffer a heart attack. The warning signs of a suspected heart attack commonly include uncomfortable pressure, fullness, squeezing or pain in the center of the chest lasting two-to-three minutes; pain spreading to the shoulders, neck and/or arms; chest discomfort with lightheadedness, fainting, sweating, nausea and shortness of breath. Individuals experiencing these signs should seek immediate medical attention. Research has shown that aspirin works by reducing the production of prostaglandins, hormone-like substances produced by the body that affect blood clotting. This reduction in prostaglandin production inhibits the tendency of blood platelets to clot -- allowing the blood to flow more freely and bring oxygen to the heart, brain and other organs. "We're pleased that the FDA has proposed new labeling for this expanded use for aspirin," said Steven Weisman, Ph.D., Director, Clinical & Medical Affairs, Bayer Corporation. "This means more lives can be saved, bringing a new meaning to the power of aspirin." Individuals should talk to their doctor before beginning an aspirin regimen. Dr. Weisman cautions that aspirin -- like all medications -- may have side effects and may not be suitable for everyone. While aspirin may be associated with stomach upset, few people have trouble taking it. In fact, less than six percent of the population cannot take aspirin because of stomach upset. In addition, special formulations exist such as enteric and buffered products to minimize stomach upset. The Consumer Care Division of Bayer Corporation is the maker of Bayer Aspirin. Bayer Corporation is a research-based company with major businesses in health care, chemicals and imaging technologies. The company had 1995 sales of $8 billion. It employs 23,500 people. Bayer Corporation, with headquarters in Pittsburgh, is a member of the worldwide Bayer Group, a $31 billion chemical and pharmaceutical company based in Leverkusen, Germany.
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