The US Food and Drug Administration set off a firestorm by calling into question a common practice: taking a baby aspirin a day to prevent heart disease. The agency first denied Bayer HealthCare’s request on May 2 to make the claim on its aspirin labels that the drug could be used to prevent a first heart attack in patients deemed by their doctors to be at high-risk of heart disease.
On May 5, the FDA posted a consumer update that said “the data do not support the use of aspirin as a preventive medication by people who have not had a heart attack, stroke or cardiovascular problems.” Side effects — like stomach ulcers and bleeding into the brain or digestive tract — outweigh the benefits even in those with diabetes, a smoking habit, or other heart disease risk factors, the FDA stated.
For those who already had a heart attack, the agency emphasized, the benefits of using aspirin to prevent another one clearly outweigh the risks. That’s something prevention experts can all agree upon — and which is already printed on the aspirin bottle.
But the FDA’s stance on using aspirin for “primary prevention” of a first heart attack runs counter to what other medical groups recommend. A daily low-dose aspirin is recommended by the American Heart Association and the American Diabetes Association for those with diabetes who have other heart disease risk factors.
In 2010, the groups “stepped back from prior recommendations that most people with diabetes should be on aspirin, and instead only recommended it for primary prevention in those at very high risk,” said Dr. M. Sue Kirkman, an endocrinologist at the University of North Carolina School of Medicine who co-authored the guideline. This includes men over age 50 and women over age 60 who have diabetes and at least one other heart risk like high blood pressure.
The US Preventive Services Task Force — a panel of primary care physicians convened by the federal government — recommends that men ages 45 to 79 take aspirin to prevent a first heart attack and women ages 55 to 79 use aspirin to prevent a first stroke if their doctor determines that the benefits outweigh the bleeding risks. Certain factors like chronic gastrointestinal pain or previous ulcers, for example, could increase the likelihood of stomach bleeding and make it too dangerous for patients to take aspirin daily. Regularly using other non-steroidal anti-inflammatory drugs like ibuprofen can also lead to higher bleeding risks.
“I can see how all of this could be confusing for people,” said Dr. JoAnn Manson, chief of the division of preventive medicine at Brigham and Women’s Hospital who helped conduct clinical trials on the use of aspirin to prevent heart attacks. “But I don’t think the FDA’s views override the guidelines of these professional medical societies.”
Patients currently taking aspirin for prevention should not stop taking their medication without first checking with their doctor since “this could be dangerous,” Manson said. But the FDA’s decision not to allow Bayer’s label change, she added, was a smart move.
“It makes it clearer to the public that they shouldn’t be using aspirin daily for primary prevention without the supervision of their healthcare provider.”
Those who pick up an aspirin bottle and read a label saying it can be used to prevent a first heart attack might wrongly assume that they should take it regardless of their own heart risk. Many assume that over-the-counter drugs come free of harmful side effects, but that’s usually not the case — especially when we take them regularly.
“Regular aspirin use for prevention needs to be individualized and personalized,” Manson said. “If it was widely used by the healthy adult population for the prevention of heart disease, it would ultimately lead to a lot more problems than benefits.”
The FDA maintains that the evidence is lacking to prove that aspirin use leads to significantly fewer heart attacks in older Americans without heart disease, but spokesperson Sandy Walsh said doctors could reasonably conclude from study data that certain high-risk groups of people get more benefits from taking aspirin than risks.
“The true message here is that patients should talk to their health care professional about whether or not to take aspirin to prevent a heart attack and stroke,” she said.Deborah Kotz can be reached at firstname.lastname@example.org. Follow her on Twitter @debkotz2.