FDA Approves Drug for Pulmonary Arterial Hypertension
The U.S. Food and Drug Administration on Friday approved the drug Letairis (ambrisentan) for the treatment of pulmonary arterial hypertension, a rare but life-threatening condition marked by continuous high blood pressure within the arteries of the lungs.
"Letairis represents a valuable addition to the treatment alternatives for this orphan disease," said Dr. John Jenkins, director of FDA's Office of New Drugs. "Letairis is similar to an existing drug, but offers the potential for fewer drug interactions."
In pulmonary arterial hypertension, the small arteries in the lungs become narrowed or blocked, so the heart must work harder to pump blood through them. Eventually, the overworked heart muscle may become weak and lose its ability to pump enough blood through the lungs. Symptoms include shortness of breath, fatigue, chest pain, dizzy spells and fainting.
About 100,000 people in the United States have pulmonary arterial hypertension, the FDA said.
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Heart Group Suggests a Lifesaving Father's Day Gift
Looking for a Father's Day gift for Sunday? The Association for Eradication of Heart Attack (AEHA) is suggesting that families give dads a heart attack prevention test. The association is also asking hospitals, clinics and physicians to offer Father's Day specials with discounted rates.
"One of the most meaningful Father's Day gifts would be a heart attack preventive screening test," said Dr. Morteza Naghavi, founder of the AEHA and chairman of its SHAPE (Screening for Heart Attack Prevention and Education) Task Force. "This is an excellent way to show Dad that you love him and want him to enjoy a long and healthy life."
The SHAPE guideline calls for men from 45 to 75 years old and women 55 to 75 years old to undergo screening to assess coronary plaque or carotid wall thickness. It also recommends the coronary calcium scan (Heart Scan) or carotid scan (Carotid IMT) -- two tests that have proven to be strong predictors of those who are vulnerable to a heart attack or stroke.
"The key is identifying asymptomatic patients at risk before a critical event occurs. With current medical therapies, we can reduce the chances of having a heart attack or sudden death by approximately 75 percent," said Dr. Daniel Berman, director of cardiac imaging at Cedars-Sinai Medical Center in Los Angeles. "The imaging tests are far more accurate than blood tests in identifying the patients at risk and in need of medical therapy."
Heart disease is the leading cause of death in the United States. According to the U.S. Centers for Disease Control and Prevention, there will be approximately 700,000 first heart attacks in 2007, and an estimated 159,600 men will lose their lives, many within an hour of the event.
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First OTC Weight Loss Drug Goes on Sale in U.S.
The first FDA-approved over-the-counter weight loss pill goes on sale across the United States Friday. The drug, called alli, prevents the absorption of fat in the intestine. It's a lower-dose version of the prescription weight-loss drug Xenical.
While some welcome the arrival of the OTC pill -- which will cost about $1.80 a day -- others have reservations or are openly critical, Newsday reported.
Weight loss specialist Dr. Dennis Gage, of Lenox Hill Hospital in New York City, isn't impressed with alli.
"The reality of weight loss pills is that people rarely lose weight when they take them. And when they do lose weight, it comes back," he told Newsday. Gage noted that Xenical produces only moderate weight loss.
Dr. Irwin Klein, chief of endocrinology and metabolism at North Shore University Hospital in Manhasset, N.Y., noted that alli causes the same side effects as Xenical, including frequent bowel movements.
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Counterfeit Toothpaste Poses Low Health Risk: Colgate
Counterfeit toothpaste imported from South Africa poses a low health risk to consumers, Colgate-Palmolive Co. said Friday.
Colgate said it analyzed samples of the counterfeit toothpaste and said its findings match the results of tests by the U.S. Food and Drug Administration, the Associated Press reported.
The counterfeit toothpaste, labeled as Regular, Gel, Triple and Herbal versions of Colgate toothpaste, were recalled in the United States because they may contain a poisonous chemical called diethylene glycol, which is used in antifreeze.
The toothpaste was sold in discount stores in New Jersey, New York, Pennsylvania, and Maryland. It was imported by MS USA Trading Inc. of North Bergen, N.J.
Colgate is currently collecting suspected counterfeit toothpaste at discount stores and is also scrutinizing all accounts that handle Colgate toothpaste to ensure that they do not have any counterfeit versions, the AP reported.
The FDA has posted an update list of recalled toothpaste products and toothpaste products that tested positive for diethylene glycol at http://www.fda.gov/oc/opacom/hottopics/toothpaste.html.
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Rotavirus Vaccine to Carry Warning About Rare but Serious Disease
A vaccine for rotavirus, the most common cause of severe diarrhea in young children, has been linked to isolated reports of a serious illness called Kawasaki disease in children who got the oral vaccine, the U.S. Food and Drug Administration said Friday.
The vaccine, called Rotateq and made by Merck & Co., was approved in February 2006. Its adverse reactions section on the label will now carry a warning about the potential risk of Kawasaki disease.
There have been five cases of Kawasaki disease among the 36,150 infants who received the vaccine and one case among the 35,536 infants who received a placebo, the FDA said in a prepared statement.
Kawasaki disease is a serious but uncommon illness in children that is poorly understood, and the cause is unknown. Symptoms include high fever and inflammation of the blood vessels. The illness can affect the lymph nodes, skin, mouth and heart, the FDA said.
The cases of Kawasaki disease reported so far are no more frequent than would be expected by chance, the agency said.
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Many Pancreatic Cancer Patients Not Offered Surgery
A U.S. study found that nearly 40 percent of early-stage pancreatic cancer patients who qualified for surgery did not get it, greatly reducing their life expectancy.
The researchers noted that about 30 percent of patients with early stage pancreatic cancer who have surgery live at least five years, compared with less than five percent of those who don't have surgery, the Associated Press reported.
The analysis of national cancer data revealed that 3,644 (38 percent) of 9,559 early-stage pancreatic cancer patients were not offered surgery. Those least likely to be offered surgery were: blacks, patients older than 65, and those with less education and lower annual incomes.
There may be a number of reasons why so many patients aren't offered surgery, said study co-author Dr. Mark Talamonti, a cancer surgeon at Northwestern Memorial Hospital in Chicago and chief of surgical oncology at Northwestern University's Medical School.
He said the factors include: lack of access to centers with experience in doing the surgery; lack of doctor awareness about improvements in the surgery; and the fact that many doctors view pancreatic cancer as a virtual death sentence, the AP reported.
The findings were published in an early online edition of the August issue of the journal Annals of Surgery.
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