FDA Says Aspirin Not Effective Against First Heart Attack

The Food and Drug Administration has issued guidance to medical personnel and the public regarding the use of aspirin in the primary prevention of heart attack and stroke. The federal agency is issuing the information in conjunction with its rejection of Bayer HealthCare’s request to allow aspirin to be marketed as a heart attack prevention method. The Centers for Disease Control (CDC) and the National Heart, Lung, and Blood Institute (NHLBI) have indicated to the FDA, that they agree with the FDA’s new position on aspirin. The FDA cautions that it is a regulatory agency and patients should talk with their doctors about treatment changes.

FDA Guidance

In its guidance, the FDA distinguishes between primary and secondary prevention. Primary prevention is for patients who have never had a heart attack. Secondary prevention is for patients who have had a cardiac event. People who do not currently have cardiovascular disease consider taking aspirin to prevent an event. The FDA is now saying that this practice is not supported by evidence, and in fact, aspirin increases the risks of bleeding in the stomach and brain. For secondary prevention, the FDA says that the evidence does support taking aspirin to prevent another stroke or heart attack because the benefits outweigh the risks of aspirin bleeding.

Bayer Request

In 2003, Bayer requested that the FDA change the label for aspirin to allow the company to market aspirin as a preventative agent. Bayer has a huge stake in the decision, selling over $1 billion in aspirin last year. The FDA says that they had been waiting since 2003 to make a decision because of several ongoing studies from which they were awaiting results. The agency said that the data from these studies published over the last several years did not demonstrate a significant benefit for aspirin in primary prevention of heart attack.

The FDA advised Bayer in a letter that it could conduct additional trials and may want to include patients from high risk groups. These patients could include diabetics, hypertensives, and those with kidney disease. Bayer could also include certain races or ethnic groups. The agency also counseled Bayer to give the FDA access to original data for a thorough and credible review.