- The FDA has released a statement counseling patients and providers to reconsider the use of aspirin as an aid for general cardiovascular health. The over-the-counter drug is not effective for preventing initial cardiovascular events, such as heart attacks and strokes, and may do more harm than good when taken on a regular basis. However, patients who have already experienced an event may still benefit from taking aspirin to prevent future crises.
“Cardiovascular disease, including heart disease and stroke, affects tens of millions of people in the United States,” the FDA says. “Consumers and patients who do not suffer from cardiovascular disease sometimes consider taking aspirin to reduce the possibility of having a heart attack or stroke. The FDA has reviewed the available data and does not believe the evidence supports the general use of aspirin for primary prevention of a heart attack or stroke. In fact, there are serious risks associated with the use of aspirin, including increased risk of bleeding in the stomach and brain, in situations where the benefit of aspirin for primary prevention has not been established.”
According to the Centers for Disease Control, cardiovascular disease was the leading cause of death in 2010, with 91,757 of those deaths deemed preventable if patients reduce their risk factors and providers work to appropriately treat diseases of the heart proactively. While professional opinion and conventional wisdom alike have long encouraged a low dose of aspirin for patients at risk of heart attack and stroke, authorities have been retooling guidelines for high cholesterol, hypertension, and other potentially serious conditions in order to reflect more evidence-based thinking.
Meanwhile, researchers are developing predictive risk scores to help target therapies to the neediest patients, helping providers move away from blanket statements and towards personalized, tailored treatments. The FDA’s new position on aspirin use follows this trend.
“We encourage patients to talk to their healthcare provider about the best treatment for their individual situation,” the statement says. “The kinds of evidence FDA uses to make regulatory decisions, which have broad public health implications, may be different from those used by a physician treating a specific patient. FDA is currently awaiting results of additional clinical trials that are underway and are estimated to have reportable results in the next few years. These clinical trials may provide new evidence that could be the basis for changing the current uses for aspirin.”