FDA Says Aspirin Effective Against Repeat Heart AttacksWILLIAM KRONHOLM , Associated Press
Oct. 10, 1985 6:25 PM ET
WASHINGTON (AP) _ The government gave its official blessing Thursday to the use of aspirin to prevent repeat heart attacks, saying cardiac patients who take one aspirin a day can reduce by one-fifth their risk of death from a second attack.
Health and Human Services Secretary Margaret M. Heckler announced that the Food and Drug Administration has concluded that taking one aspirin per day is a safe and effective way to prevent heart attacks in people who already have had one and to treat patients with unstable angina.
Studies supporting the decision did not deal with whether healthy people also benefit by taking an aspirin a day, Mrs. Heckler said. But she noted that many physicians routinely take an aspirin each day.
''There's a certain reasonableness to thinking it might be'' useful in healthy people, added Dr. Robert Temple, FDA's drug chief. ''But that's not the same as knowing it.''
Mrs. Heckler also announced FDA approval of a $15,000 implantable defibrillator that can deliver a life-saving electrical jolt to the heart of a person suffering a potentially fatal heart flutter.
Rescue squads use portable defibrillators that administer such jolts, but the new implanted defibrillator fires its jolt as soon as the heart loses its rhythm.
About 1.5 million people suffer from ventricular tachycardia, the heart problem that causes the flutter, Temple said. About 400,000 of those cannot be helped by drugs and could be candidates for an implant.
Mrs. Heckler estimated that aspirin could save 30,000 to 50,000 lives each year; the implantable defibrillator could save 10,000 to 20,000 lives, she said.
The secretary announced the actions at her first news conference since she announced that she was resigning as HHS secretary to become ambassador to Ireland. She resigned at President Reagan's request after she lost a high- level power struggle with the White House staff.
In making that announcement at the White House last week, she was tense and appeared near tears. But she was cheerful and relaxed at Tuesday's session, telling reporters afterward that an Irish minister with whom she met Thursday assured her of his country's ''enormous support and the congeniality of the welcome I will receive there.''
She said she expects Senate consideration of the ambassadorial appointment in about a month.
Until then, she will remain at HHS. ''I have an agenda to finish up,'' she said.
In the aspirin announcement, Mrs. Heckler noted that the drug ''is not a substitute for other preventive therapies for heart attack. A lot of us need to stop smoking, eat better, lose weight and exercise sensibly.''
But she said seven clinical studies involving more than 11,000 heart patients clearly showed beneficial results for people who have suffered heart attacks and among men with unstable angina, or worsening chest pain.
For those who have suffered a heart attack and take one aspirin each day, she said, risk of death is reduced by one-fifth. Among men who suffer from unstable angina and took an aspirin each day, the risk of dying from a heart attack dropped by about one-half.
The FDA action on aspirin will mean little visible change to consumers. Technically, it agreed to let aspirin companies change the wording of information sent to physicians to recommend use of aspirin for heart patients.
Bottle labels on drugstore shelves and advertisements aimed at the public still cannot promote aspirin use to prevent heart attacks, but Mrs. Heckler said that may change if FDA and the industry can agree on wording.
The implantable defibrillator, a 1.5 pound device a little larger than a deck of playing cards, is produced by Cardiac Pacemakers Inc. of St. Paul, Minn., a subsidiary of Eli Lilly and Co.
Sudden, fatal heart attacks among people suffering from ventricular tachycardia have been reported from a low of 27 percent a year to a high of 66 percent, the FDA said. Clinical trials by 323 patients showed that the death rate could be reduced to less than 5 percent with the implanted device.
FDA approval means that the cost of the device can be covered by medical insurance, Mrs. Heckler said.