FDA Announces that the Risks of Daily Aspirin Outweigh Benefits in People Who Never Suffered A Heart Attack

FDA_Announces_Risks_of_Aspirin Federal regulators have announced that taking daily aspirin is not a protocol that should be used by people who have never had a heart attack but who may believe that they are at risk for having a heart attack.

The U.S. Food and Drug Administration (FDA) reviewed literature that led to its announcement. Although daily aspirin may be the recommended treatment protocol for people who have suffered a prior heart attack, there is not enough evidence to show that, for people who have not had a heart attack and who do not have a previous history of cardiovascular disease, that the risks of taking the drug daily outweigh any benefits of its benefits, the FDA wrote, according to Forbes.

The announcement came after a denial by the agency to Bayer which requested a labeling change that would indicate that the use of aspirin is suggested as a preventative measure against heart attack in people with no history of heart attack, Forbes wrote.

“Since the 1990s, clinical data have shown that in people who have experienced a heart attack, stroke or who have a disease of the blood vessels in the heart, a daily low dose of aspirin can help prevent a re-occurrence,” said Robert Temple, deputy director for clinical science at the Food and Drug Administration (FDA), in a statement on the FDA website. The FDA warns people to be aware of the dangers associated with taking aspirin when they are also taking prescription blood thinners like warfarin, Pradaxa (dabigatran), Xarelto (rivaroxaban), and Eliquis (apixibans), Forbes reported.

No data exists that suggests daily aspirin treatment is sufficiently effective for people who never had a heart attack, even when a family history of cardiovascular disease exist; no research suggests that there will be sufficient benefit to outweigh associated risks, Forbes reported. The FDA concluded that current data simply do not support aspirin use as a form of what it described as a form of “primary prevention” in people who never suffered a prior heart attack or stroke and who have not been diagnosed with vascular problems.

Also, according to the FDA, regularly taking aspirin over a period of time may cause internal bleeding, which is a risk that is not outweighed by the benefits of aspirin, according to the FDA. The agency also indicated that aspirin’s risks far outweigh any potential benefits, Forbes reported. “The benefit has not been established but risks—such as dangerous bleeding into the brain or stomach—are still present,” the FDA wrote. Large-scale studies are underway, and the FDA indicated that it will be tracking that research in the event that its recommendation may require future change.

The Mayo Clinic does note that suddenly ceasing an aspirin regimen when that regimen has long been followed may create what is known as a “rebound effect.” When this happens, the heart attack risk increases. People with no history of heart disease and who have not had a heart attack, but who are on an aspirin regimen, are advised to consult with their physician before stopping the treatment, Forbes noted.

“Since the 1990s, clinical data have shown that in people who have experienced a heart attack, stroke, or who have a disease of the blood vessels in the heart, a daily low dose of aspirin can help prevent a reoccurrence,” Temple says. (A dose ranges from the 80 milligrams (mg) in a low-dose tablet to the 325 mg in a regular strength tablet.) This use is known as “secondary prevention.”

“The bottom line,” wrote the FDA, “is that in people who have had a heart attack, stroke or cardiovascular problems, daily aspirin therapy is worth considering. And if you’re thinking of using aspirin therapy, you should first talk to your health care professional to get an informed opinion,” Temple says.

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