FDA: More data needed to approve AstraZeneca's Brilinta

The United States Food and drug Administration did not approve a new heart medicine Brilinta or ticagrelor made by AstraZeneca as it says more data are needed to make a firm decision.

On July 26, an FDA advisory committee voted 7 to 1 to recommend that the FDA approve Brilinta even though almost all panelists had concern about the study results.

Brilinta is indicated to be used as an anti-clotting medication, which in a recent clinical trial showed the drug was effective in treating chest pain and heart attack or myocardial infarction in patients with acute coronary syndrome, according to drugwatch.com.

In the Nov 2010 issue of Future Cardiology, Siller-Matula JM and Jilma B from Medical University of Vienna in Vienna Austria reported "The Phase III clinical study of Platelet Inhibition and Patient Outcomes (PLATO) has shown that ticagrelor reduced ischemic events and all-cause mortality without an increase in major bleeding complications."

The potential advantage of Brilinta, according to the researchers, is that the drug results in rapid onset of action, which is desired prior to percutaneous coronary interventions or sometimes prior to coronary artery bypass graft surgery.

However, the authors said Brinlinta comes with some potential disadvantages including more side effects such as dyspnea, ventricular pauses or an increase in uric acid and creatinine.

Siller-Matula and Jilma wrote "ticagrelor did not only reduce death due to vascular causes but also all-cause mortality."

American Academy of Family Physicians recommends the following measures to reduce risk of myocardial infarction:

1, Quit smoking;

2, Eat a healthy diet;

3, Control blood sugar if you are diabetic;

4, Exercise;

5, Lose weight if you're obese or overweight;

6, Control blood pressure if you have high blood pressure.

The physician organization also says aspirin can help keep the blood from forming clots that can lead to block the arteries.