FDA to propose guidelines on med device reports—NYT
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The Food and Drug Administration will soon propose guidelines meant to make the annual safety reports filed by manufacturers of medical devices more complete and more accessible to the public, The New York Times reported on Saturday.
Dr. Daniel Schultz, the director of the FDA’S Center for Devices and Radiological Health, told the newspaper that the changes were part of a wider effort to improve the agency’s monitoring of medical devices after they are approved for sale.
U.S. health experts to review OTC weight-loss drug
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U.S. health experts on Monday will weigh what could become the first nonprescription weight-loss drug approved for use in the United States, where nearly two thirds of the population is overweight and obesity rates continue to rise.
The drug, GlaxoSmithKline’s low-dose version of Xenical, will come before a U.S. Food and Drug Administration advisory panel for discussion about whether to allow over-the-counter sales.
Vision Risk From ED Medications
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Men with a history of heart attack who use the popular erectile dysfunction medications Viagra or Cialis may be at increased risk for vision loss, according to new UAB research published in the British Journal of Ophthalmology. The study draws a link between the medications and non-arteritic anterior ischaemic optic neuropathy (NAION), which can cause vision loss in one or both eyes. “We found a strong link between use of Viagra or Cialis and NAION in men with a history of heart attack,” said Gerald McGwin, Ph.D., associate professor of ophthalmology.
“We found similar results in men with hypertension that, while not as dramatic, are substantial enough to indicate that men with a history of heart disease should be warned of the risks of NAION before use of these medications.”
Slower Reaction Times Linked to Higher Death Risk, Even in Young Adults
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Slower reaction times and poorer memory are associated with a greater risk of dying in young and old people, a new study shows.
The finding in younger subjects is especially surprising, given that prior research linking higher mortality with poorer cognitive function in the elderly was attributed to degeneration of the brain due to aging.
Age-Related Memory Improvement Linked with Consumption of Apple Products
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“An apple a day” now has new meaning for those who want to maintain mental dexterity as they age. New research from the University of Massachusetts Lowell suggests that consuming apple juice may protect against cell damage that contributes to age-related memory loss, even in test animals that were not prone to developing Alzheimer’s disease and other dementias.
“This new study suggests that eating and drinking apples and apple juice, in conjunction with a balanced diet, can protect the brain from the effects of oxidative stress – and that we should eat such antioxidant-rich foods,” notes lead researcher Thomas B. Shea, Ph.D., director of the University of Massachusetts Lowell’s Center for Cellular Neurobiology and Neurodegeneration Research, whose study was just published in the latest issue of the Journal of Alzheimer’s Disease. Although more research is needed, Shea is excited about these brain health findings, which are encouraging for all individuals who are interested in staying mentally sharp as they age.
Breastfeeding may reduce risk of celiac disease
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Sufferers from celiac disease can’t tolerate wheat and gluten in their diet, but people who were breastfed as babies seem to be less likely to develop the condition, a UK study shows.
Dr. A. K. Akobeng, of Booth Hall Children’s Hospital, Manchester, and colleague note in the Archives of Diseases in Childhood that “recent observational studies suggest that breastfeeding may prevent the development of celiac disease.”
Human body has a unique immune system response to foreign DNA
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The human body has a unique immune system response to foreign DNA, suggesting that DNA viruses and RNA viruses are detected by different mechanisms, Yale School of Medicine researchers report this week in Immunity.
The researchers also found that DNA recognition might be used to detect invasive bacteria in addition to viruses, according to Daniel Stetson, a post doctoral fellow in the Section of Immunobiology and lead author of the study.
Tips for Women (and Men) in Search of a Good Night’s Sleep
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For many women, it’s tough to get a good night’s sleep. Studies show that women may be 20 percent to 50 percent more likely to have insomnia than men.
One culprit behind women’s sleep difficulties can be fluctuating hormone levels. With optimal levels of estrogen and progesterone in your system, the time it takes to fall asleep and the number of awakenings during the night decrease. But hormone fluctuations occur for many reasons, including monthly menstrual cycles, use of birth control pills, pregnancy, and perimenopause—the five to 10 years before and up to one year after menstrual periods end.
If you find yourself tossing and turning at night, simple changes in your daily and nightly habits may result in better sleep. The January issue of Mayo Clinic Women’s HealthSource offers these suggestions:
Work Stress Leads to Heart Disease and Diabetes
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Chronic stress at work and the metabolic syndrome: prospective study BMJ Online First
Stress at work is an important risk factor for the development of heart disease and diabetes, finds a study published online by the BMJ today.
Keeping Sexual Desire in Sync Past Midlife
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When it comes to desire and drive for sexual intimacy, many women at midlife find they are no longer in sync with their partners.
Although many people assume that a decrease in sexual desire inevitably occurs at midlife, that’s not necessarily the case. Age has less of an impact on sexual desire than does general health and availability of a willing and able partner.
But aging does play a role, according to the Mayo Clinic Women’s HealthSource. After menopause, thinning of the vaginal tissues and decreased lubrication may cause pain or discomfort during sexual stimulation. Less hormonal flucuation in women can pose a challenge; couples need to become more creative in their lovemaking, allowing additional time and stimulation for arousal.
FDA unpopular over label liability revamp
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The Food and Drug Administration in the U.S. has said that federally approved drug labels pre-empt state liability laws and are part of a revamp of the lengthy, hard-to-read instructions that come with medicines.
It also says that the pre-emption of state laws address drug makers’ concerns that the streamlined summary of risks could increase their liability if patients alleged the warnings were inadequate.
New study gives insight into the dairy and weight loss link
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A new clinical trial published today in Obesity Research (the journal of NAASO, the Obesity Society) provides more insight into why consuming dairy foods is linked to weight and fat loss.
This well-controlled study found that when exercising adults on a slightly reduced-calorie diet consumed 3 to 4 servings of dairy foods daily, their metabolism changed so that their bodies burned more fat than they did when they had one serving of dairy under the same conditions.
Wine drinkers choose healthier foods, study shows
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Wine drinkers have healthier diets than people who prefer beer, according to research reported by Danish scientists on Friday.
They tend to buy more fruits, vegetables, olives, low fat cheese and cooking oil than beer drinkers who are more likely to consume ready meals, soft drinks, sugar, sausages, lamb and butter or margarine.
New cancer warnings added to eczema creams
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Eczema creams sold by Novartis AG and Astellas Pharma Inc. will come with a “black-box” warning about a possible risk of cancer from the prescription treatments, U.S. regulators said on Thursday.
A black-box warning is the strongest type used in the United States for prescription drugs.
The new warnings apply to Novartis AG’s drug Elidel and Astellas Pharma’s Protopic.
NY smokers sue Philip Morris for cancer screenings
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A group of heavy Marlboro smokers filed a lawsuit in federal court on Thursday, asking Philip Morris USA to pay for screenings that may detect the early stages of lung cancer.
The class-action lawsuit, which was filed on behalf of current and former Marlboro smokers over 50 years old who smoked a pack or more a day for 20 years, demands the tobacco company pay for an annual low-dose CT scan of the chest.
