FDA Comes Out Towards Aspirin To Avert First Heart Attacks

In the most recent advancement in a prolonged-simmering debate, the FDA has announced that aspirin need to not be marketed for the prevention of a very first heart assault or stroke in individuals with no background of cardiovascular disease. The announcement follows FDA’s rejection on Friday of Bayer Healthcare’s decade-old  petition requesting approval of a primary prevention indication. [PDF of FDA rejection letter]

Aspirin is even now widely employed for main prevention. Several physicians, including cardiologists, advocate it for some of their patients. The American Heart Association at present supports the use of aspirin for primary prevention when recommended by a doctor in large risk patients.  (There is  widespread agreement that for secondary prevention the advantages of aspirin outweigh the hazards and ought to be used to avert a 2nd heart attack or stroke soon after an earlier cardiovascular event.)

In its statement the FDA said it had “reviewed the offered data and does not think the evidence supports the basic use of aspirin for primary prevention of a heart attack or stroke. In fact, there are severe hazards connected with the use of aspirin, including increased threat of bleeding in the abdomen and brain.” The FDA reaffirmed the use of aspirin in secondary prevention.

Cardiologist Sanjay Kaul, who typically serves as an FDA consultant and advisory committee member, presented the following comment:

There have been 9 major prevention trials evaluating the function of aspirin in CVD. Not a single trial has been optimistic so far. When the information are pooled collectively in a meta-examination, there is a small, but statistically significant, benefit which is counterbalanced by an equally modest but statistically substantial danger of bleeding. On balance, the totality of evidence does not yield a favorable advantage-risk ratio for aspirin in major prevention. FDA declined to approve aspirin for major prevention in 2003. Total, I agree with the FDA’s stance. The tough task ahead for specialist societies is to acknowledge the tepid evidentiary support for their guideline recommendations. Equally tough a task is that  patients will have to recalibrate their opinions about aspirin for main prevention of CV ailment.

FDA Comes Out Towards Aspirin To Avert First Heart Attacks