FDA Finds No Evidence Linking Tamiflu to Deaths
The U.S. Food and Drug Administration said Friday there was insufficient evidence to tie the flu drug Tamiflu to the deaths of 12 Japanese children or to hallucinations, encephalitis and other symptoms suffered by some Japanese patients.
One day after announcing it would review the deaths, the agency's staff said it wouldn't be necessary to update the drug's labeling to reflect those deaths or possible adverse effects. But the staff is recommending adding information to the label about serious skin reactions to Tamiflu, according to papers prepared for a meeting Friday of the FDA's Pediatric Advisory Committee, the Associated Press reported.
At the meeting itself, the chairman, Dr. Robert Nelson, said, "If we ever have a pandemic of avian flu, which is a debatable point, people want to know that they have a drug that will not cause more (harm) than the flu itself," said.
The advisory committee reviewed Tamiflu as part of a routine safety check of drugs whose original uses had been extended to cover children.
Melissa Truffa, of the FDA's Office of Drug Safety, told the panel earlier Friday that they found no direct link between the use of Tamiflu and the deaths in Japan.
The FDA staff said Tamiflu is used much more often in Japan than in the United States -- 11.6 million prescriptions for children in Japan between 2001 and 2005, compared to about 872,000 during that same period in the United States, AP reported.
There are no reports of deaths in the United States or Europe associated with Tamiflu.
China Gives OK to New Type of Cancer Drug
China has become the first country to approve a cancer therapy that uses a virus to attack only malignant tumor cells.
The New York Times reports that the drug, called H101, is actually a modified version of a treatment originated and abandoned by an American biotech company. The original drug was developed by a California company, Onyx Pharmaceuticals and was called -- appropriately -- Onyx-015.
Both Onyx-015 and H101 use a genetically engineered cold virus that zeroes in only on cells with a genetic defect found in cancer cells, the Times reports. There were some operational problems with the drug in America, the newspaper reports, and Onyx dropped the drug in 2003. It has since developed another anti-cancer drug that is awaiting approval by the U.S. Food and Drug Administration.
The Chinese company, Shanghai Sunway Biotech, has approval to market H101 to treat head and neck cancer, according to the Times.
Possible Cause of Kawasaki Disease Reported
Northwestern University scientists say that they have discovered a possible cause of Kawasaki disease, a heart ailment that strikes an estimated 15 of every 100,000 children in the United States. Kawasaki disease, first discovered in 1967, is the most common cause of acquired heart disease in children.
Early diagnosis is extremely important, because the disease can be treated. But diagnosis can be missed, and the result can be a long and difficult illness.
Kawasaki disease has long been believed to be caused by some sort of infection, but it has so far been unidentified. The latest research from Northwestern scientists indicates the cause may be viral.
In a news release, the university says its research team from the Feinberg School of Medicine and Children's Memorial Hospital completed findings that show how the virus spreads through a childs body. "The virus is likely to be taken up by white blood cells in the lung and carried through the bloodstream, infecting other tissues, including the coronary artery, and leading to coronary artery aneurysms, the most important adverse outcome of Kawasaki disease," said Dr. Anne H. Rowley, a professor of pediatrics and of microbiology/immunology who led the research.
The findings are reported in the Nov. 15 issue of Journal of Infectious Disease.
Major Depression Afflicts 8 Percent of U.S. Adults
About eight percent (17 million) of U.S. adults reported suffering at least one bout of major depression during the previous year, according to a report released Friday by the Substance Abuse and Mental Health Services Administration.
About two-thirds of the people who reported major depression in the previous year said they'd received treatment, which included taking prescription medications or talking with a doctor or other health professional.
Illicit drug use within the previous month was almost twice as high among adults who reported major depression than among people who did not report major depression, according to the data. The report, based on the 2004 National Survey on Drug Use and Health, also showed that 39.7 percent of adults who reported major depression smoked cigarettes in the previous month, compared to 25.9 percent of adults who did not have major depression.
Women were almost twice as likely as men to report major depression (10.3 percent vs. 5.6 percent) and women who did experience major depression were more likely than men with depression to receive treatment (70.1 percent vs. 55.2 percent).
The report said that major depression occurred in about 10 percent of adults ages 18-49 and in about 1.3 percent of adults ages 65 or older.
FDA Issues Caution on Bronchodilators
The U.S. Food and Drug Administration on Friday issued a public health advisory about long-lasting bronchodilator medicines called long-acting beta 2-adrenergic agonists (LABAs) and told companies that make the medicines to update existing product labels with new warnings.
The FDA says these medicines -- Serevent Diskus, Advair Diskus and Foradil Aerolizer -- may increase the risk of severe asthmatic episodes and increase the risk of death when the episodes occur. LABAs help relax the muscles around the airways in the lungs. Even though LABAs decrease the frequency of asthma episodes, they may make asthma episodes more severe when they do occur, the FDA said.
The advisory offers the following recommendations for the use of LABAs in asthma patients:
LABAs should not be the first medicine used the treat asthma and should be added to asthma treatment only if other medicines do not control asthma.
Don't stop using your LABA or any other asthma medicines that have been prescribed for you unless you've talked with your healthcare provider about whether or not to continue treatment.
Don't use your LABA to treat wheezing that's getting worse. Call your healthcare professional immediately if your wheezing becomes worse while using a LABA.
LABAs don't relieve sudden wheezing. Always have a short-acting broncodilator medicine with you to treat sudden wheezing.
Food Fact:
Some like it hot.
With good reason -- chiles' heat may bring you significant health protection. Capsaicin, the compound that gives chile peppers their firey heat, contains an anticoagulant that might help prevent heart attacks and strokes caused by blood clots. Chile peppers also contain a mixture of cancer-fighting antioxidants. Remember, don't touch your eyes as you're working with chile peppers, and wash your hands thoroughly afterward. As a general rule, the larger the pepper, the milder it is. To reduce a pepper's intensity, remove the core and seeds.
Fitness Tip of the day:
We've got your back!
If back muscles become tight and sore after exercise -- a common feeling -- a great way to relieve this stress is to lie on the floor with a tennis ball between your back and the floor and give yourself a massage.
FAQ of the day:
Does cranberry juice cure urinary tract infections?
Cure is too strong a word, but cranberry juice has been shown in carefully controlled experiments to help prevent recurrent urinary tract infections, or UTIs. Research in the late 1980s reported that cranberry juice (as well as blueberry juice) prevented common bacteria from adhering to cells that line the urinary tract. Studies in the '90s found that women who drank about 10 oz. of cranberry juice a day had lower levels of bacteria in their urine, and were 75% less likely to develop urinary tract infection in the next month.
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