FDA approves blood thinner Brilinta
After a long wait, the Foods and Drugs Administration authorities have given an approval to a new blood thinning medication, Brilinta. This medicine will be beneficial to patients diagnosed with severe cardiac symptoms. Brilinta will reduce the possibility of a heart attack that may cause death in such patients. Acute cardiac symptoms include conditions, such as unstable angina or cardiac arrest due to reduced blood flow to the heart. The FDA authorities in its statement said that Brilinta, which is developed by AstraZeneca assists patients by reducing the formation of new blood clots, which increases their risk.
Boxed warning required by FDA
The new medicine will be an alternative that will be available to the present medication Plavix that is presently available. During the trials, Brilinta proved more effective to reduce cardiac arrest and death. In addition, the medicine has a bigger advantage in when administered with daily doses of aspirin ranging between 75 and 100 mg. However, the FDA has made it compulsory for the company to provide a warning on the packaging that the medicine’s effectiveness reduce if the aspirin dose is more than 100 mg per day.
Increases risk with high aspirin dose
Moreover, AstraZeneca will have to conduct education of physicians to warn them about the increased risk when the medicine is used with high aspirin doses. The warning must provide the increase in the bleeding that occurs with any blood thinning medication. Another side effect of the new medicine was shortness of breath.
A study to show its effectiveness
A study conducted in June was presented at the American Heart Association press conference. The results showed that when patients used Brilinta with aspirin doses below 300 mg was more effective than Plavix taken with low aspirin doses. The medication reduced the complications of acute coronary diseases. However, the advantages were eliminated when Brilinta was combined with higher doses of aspirin.
Low aspirin doses recommended
Assistant professor of medicine at NYU Langone Medical Center, Dr. Jeffrey Berger, said that the study undertaken to prove the benefits of Brilinta show that low aspirin doses are more beneficial. He said that limiting the aspirin dose to 81 mg per day as against the recommended dose of 325mg per day was more effective in reducing the fatal effects of acute cardiac symptoms. A higher dose of aspirin only increases the risk of bleeding without increasing the benefits of the medicine.