FDA Approves New Hypertension Tablet
A new blood pressure tablet called Tekturna HCT was approved Monday by the U.S. Food and Drug Administration, according to drug maker Novartis AG, the Associated Press reported.
The new tablets contain the hypertension compound aliskiren (brand name Tekturna) and hydrochlorothiazide, which inhibits the kidneys' ability to retain water. Tekturna HCT is meant for patients whose blood pressure hasn't been brought under controlled by a single drug.
It will be available in the United States in February, the AP reported.
Dizziness, flu-like symptoms, diarrhea, cough, tiredness and skin rashes are among the side effects associated with Tekturna HCT.
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Lack of Food Not Linked to Obesity in Low-Income Children: Study
A new study challenges the common theory that lack of food explains why children in low-income families are more likely to be overweight than children from higher-income families, the Associated Press reported.
Previous research suggested that children in low-income families didn't get enough nutritious food and ate hot dogs and other poor-quality foods instead. It's also been suggested that some children eat well when there's enough money but skip meals when cash is short -- a cycle that may slow their metabolism and lead to weight gain.
But this Iowa State University study of 1,031 children living in low-income homes in Boston, Chicago and San Antonio disputes those theories. The study found that while half of the children in the study were overweight or obese, only about 8 percent weren't getting enough to eat, the AP reported.
While the Iowa State researchers concluded that there's no link between lack of food and overweight/obesity in low-income children, they couldn't say why so many children in low-income families have weight problems.
More research is needed to better understand the issue, the study authors said.
According to some studies, nearly one-third of American children ages 10 to 17 are overweight or obese, and nearly 40 percent of those overweight/obese children are from low-income families, the AP reported.
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Flu Vaccination Rates Lower Than Expected
Flu vaccination rates among children and high-risk adults in the United States are much lower than expected. That means that millions of people would be unprotected if there's a major flu outbreak, says a report released Monday by the University of Michigan C.S. Mott Children's Hospital National Poll on Children's Health.
The latest online survey of 2,131 adults, ages 18 and older, was conducted in December. It found that among households with children ages 5 and younger, there was only a 36 percent vaccination rate. Another 18 percent of households said they still planned to vaccinate their children this season.
The poll also found that flu vaccination rates among high-risk adults -- those ages 50 and older and those with chronic diseases -- were well below national target levels.
So far this season, 26 states have reported moderate flu activity. There are about 40 million doses of flu vaccine still available and parents should get themselves and their children vaccinated, said Dr. Matthew M. Davies, director of the National Poll on Children's Health.
"National efforts to prevent an influenza epidemic in the U.S. hinge on broad flu vaccination of the public before flu season hits," David said in a prepared statement.
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Cell Phones May Disrupt Sleep: Study
Talking on a cell phone before bedtime may disrupt your sleep. So says a cell phone industry-funded study conducted by researchers from Wayne State University in Detroit and the Karolinska Institute in Sweden.
They found that radiation from a cell phone can cause insomnia, headaches and confusion and may reduce the amount of deep sleep, thus interfering with the body's ability to refresh itself, BBC News reported.
The study included 35 men and 36 women, ages 18 to 45. Some were exposed to radiation equivalent to that received when using a cell phone, while others received only "sham" exposure.
The volunteers exposed to radiation took longer to enter the first of the deeper stages of sleep, and spent less time in the deepest stage, than those not exposed to radiation, BBC News reported.
The findings "strongly suggest that mobile phone use is associated with specific changes in the areas of the brain responsible for activating and coordinating the stress system," said researcher Professor Bengt Arnetz, BBC News reported.
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Off-Label Use of Biliary Stents to Treat PVD Increasing: Study
Off-label use of biliary stents is increasing and the majority of adverse events and device malfunctions involving such stents occur during off-label use, says a U.S. study published Monday in the American Journal of Therapeutics.
In the United States, biliary stents are approved as a palliative treatment for cancer patients who've developed bile duct obstructions. But these stents are often used for off-label treatments, especially for peripheral vascular disease (PVD).
"Our study found that more than one million patients received biliary stents for off-label treatments between 2003 and 2006," study senior author Dr. William Maisel, a cardiologist and director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center in Boston, said in a prepared statement. "We also found that more than 80 percent of the reported adverse events and device malfunctions associated with these products have occurred during off-label use."
Between 2003 to 2006, the use of biliary stents in PVD patients increased 21.4 percent, from 227,145 to 275,795.
There is little data supporting the clinical effectiveness and safety of biliary stents in PVD patients, the researchers noted.
"Our analysis raises several important issues," Maisel said. "The frequent off-label use of biliary stents for treatment of peripheral vascular disease implies an unmet need in the management of these patients. With the aging of the U.S. population, the number of patients with vascular disease can be expected to grow. Efforts should be directed at improving the evaluation of devices used to treat peripheral vascular disease in order to better identify those patients that will most benefit from this promising therapy."
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FDA Review: Sale of OTC Cholesterol Drug Poses Risks
Is it three strikes and you're out for over-the-counter (OTC) sales of the cholesterol-lowering drug Mevacor?
Twice before, the drug's maker, Merck & Co., has asked the U.S. Food and Drug Administration to approve it for OTC sales. The most recent was just last month, and an FDA advisory panel overwhelmingly recommended against approval.
Now, the Associated Press reported, an FDA review released last week still has major doubts. Positive news for Merck was that the staff reviewer found that nonprescription Mevacor would be "a reasonably safe and effective" option, the wire service reported -- if consumers used it as directed.
And that presents a big problem, the AP reported. An FDA review of a Merck-conducted consumer survey found there was too much confusion as to who should be taking Mevacor and for what reason.
The FDA conclusion: The survey results "have not convinced this reviewer that there is adequate consumer comprehension of the proposed product label to ensure safe and effective use of this product," according to the AP.
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