FDA Proposes Labeling Aspirin For Use At Onset Of Heart Attack

June 14, 1996

GAINESVILLE—In a move physicians say will save thousands of lives each year, the Food and Drug Administration has proposed sanctioning the use of aspirin to reduce the risk of death from the nation’s No. 1 killer — heart attack.

As many as 10,000 people annually could be saved, estimates Dr. Carl Pepine, co-director of cardiovascular medicine at the University of Florida College of Medicine.

Pepine was a key player in the Aspirin Strategy Group, a prestigious team of nine physicians who petitioned the FDA in 1993 to approve aspirin for use in reducing the risk of death during a suspected heart attack.

Concerned citizens have 90 days to make any comments, which the FDA could opt to incorporate into the proposed law, scheduled to become effective within a year.

The proposed labeling is the first of many new uses for aspirin under consideration by the FDA.

About 1.5 million people suffer heart attacks each year in the United States, according to the American Heart Association. Half die, most before they get to the hospital.

Research has shown as little as one-half a regular-strength aspirin taken as soon as a heart attack is suspected, and continued for at least a month under a doctor’s supervision, significantly reduces the risk of death.

Aspirin is thought to work by inhibiting the production of an enzyme in blood platelets that causes blood to clot. Blood clots and plaque buildup can block the travel of blood through arteries much like clogged pipes slow the flow of water, reducing blood supply to the heart. A prolonged reduction in blood flow can cause permanent damage to the heart muscle — a heart attack.

“People who suspect they are having a heart attack should call for medical help and take an aspirin,” Pepine said. “I’m delighted with the FDA’s decision, though I’m disappointed that something that has such potential to save so many lives took so long. But it’s better late than never.”