FDA approves first artificial aortic heart valve placed without open-heart surgery (USA)

The U.S. Food and Drug Administration has approved the first artificial heart valve that can replace an aortic heart valve damaged by senile aortic valve stenosis without open-heart surgery. Senile aortic valve stenosis is a progressive, age-related disease caused by calcium deposits on the aortic valve that cause the valve to narrow. As the heart works harder to pump enough blood through the smaller valve opening, the heart eventually weakens, which can lead to problems such as fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), or cardiac arrest

FDA approves blood-thinning drug Brilinta to treat acute coronary syndromes (USA)

The U.S. Food and Drug Administration has approved the blood-thinning drug Brilinta (ticagrelor) to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS). ACS includes a group of symptoms for any condition, such as unstable angina or heart attack, that could result from reduced blood flow to the heart. Brilinta works by preventing the formation of new blood clots, thus maintaining blood flow in the body to help reduce the risk of another cardiovascular event. Brilinta has been studied in combination with aspirin. A boxed warning to health care professionals and patients warns that aspirin doses above 100 milligrams per day decrease the effectiveness of the medication

FDA panel approves cardiac therapy device (USA)

"A U.S. Food and Drug Administration advisory panel has approved a therapy to reduce mortality and heart failure risk in patients with mild cardiac disease. The FDA panel recommended the cardiac resynchronization therapy defibrillator be approved for use in patients with mild heart failure. The device was tested in a series of nationwide studies led by Dr. Arthur Moss, professor of medicine at the University of Rochester Medical Center. Developed by the Boston Scientific Corp., the defibrillator was previously approved to treat patients with severe heart failure. The FDA often, but not always, follows the recommendations of its advisory panels" - UPI

FDA warns about increased risk of muscle injury with Zocor (USA)

"The U.S. Food and Drug Administration has warned patients and healthcare providers about the potential for increased risk of muscle injury from the cholesterol-lowering medication Zocor (simvastatin) 80 mg. Although muscle injury (called myopathy) is a known side effect with all statins, [today's] warning highlights the greater risk of developing muscle injury, including rhabdomyolysis, for patients when they are prescribed and use higher doses of this drug. Rhabdomyolysis is the most serious form of myopathy and can lead to severe kidney damage, kidney failure, and sometimes death"

FDA won't accept Merck's application for new drug (USA)

"U.S. regulators won't accept drugmaker Merck's application for a new combination cholesterol pill that includes rival Pfizer's Lipitor, the world's top-selling drug. Merck & Co. disclosed the rare move by the Food and Drug Administration in a regulatory filing on Monday. The company had said about 2 1/2 years ago that it planned to make and market a cholesterol pill combining Pfizer Inc.'s Lipitor with Zetia, a cholesterol pill Merck jointly sells with partner Schering-Plough Corp. In September, Merck applied to the FDA for approval of its combo pill. But Merck says the FDA refused to file the application and instead is requiring more data on the manufacturing and stability of the drug. The FDA hasn't responded to requests for comment." AP

FDA approves Effient to reduce the risk of heart attack in angioplasty patients

The U.S. Food and Drug Administration has approved the blood-thinning drug Effient tablets (prasugrel) to reduce the risk of blood clots from forming in patients who undergo angioplasty, a common procedure to unblock a clogged coronary artery. During an angioplasty, a balloon is used to open the artery that has been narrowed by atherosclerotic plaque.Often, a tiny wire mesh scaffold (stent) is inserted into the blood vessel to help keep the artery open after the procedure. Platelets in the blood can clump around the procedure site, causing clots that can lead to heart attack, stroke, and death. Effient was studied in a 13,608-patient trial comparing it to the blood-thinning drug, Plavix (clopidogrel), in patients with a threatened heart attack or an actual heart attack who were about to undergo angioplasty