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Nycomed Announces FDA Filing For Daxas(R) In COPD
Nycomed announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Daxas® as a once-daily oral treatment for patients with symptomatic COPD. The NDA submission is based on encouraging results from four Phase III trials of Daxas® (roflumilast) in the treatment of symptomatic COPD. Two pivotal 12-month studies showed positive effects on exacerbation rates and pulmonary function (FEV1). Two supporting six-month studies also confirmed the efficacy of Daxas when used with standard bronchodilator treatments. Full data from all four studies are to be published during 2009.
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A Training Technique Has Brain, Physiological Linkage: Chinese Data Unraveled At University Of Oregon
Chinese researchers have unlocked the mechanism of an emerging mind-body technique that produces measurable changes in attention and stress reduction in just five days of practice.
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Studies Examine Morning Sickness Drug, Progesterone Use To Prevent Premature Birth
The following summarizes news coverage on two pregnancy-related studies. ~ Morning sickness: The commonly prescribed heartburn drug metoclopramide -- sold generically and under the brand-names Reglan, Octamide and Maxolon -- can be used to treat morning sickness without harming the health of the fetus, according to a study published on Thursday in the New England Journal of Medicine, Time reports. The drug, which also has anti-nausea properties, is not FDA-approved for use in pregnant women in the U.S., though it is commonly prescribed in European and other countries to treat morning sickness (Park, Time, 6/10). According to the Los Angeles Times, U.S. physicians occasionally prescribe metoclopramide to treat severe morning sickness cases. The new study found that there were no statistically significant differences between infants born to women who took metoclopramide and those who did not. Researchers said that the findings "provide reassurance regarding the safety of metoclopramide for the fetus when the drug is given to women to relieve nausea and vomiting during pregnancy." The study involved 81,703 births among women enrolled in Israel"s largest health HMO, including 33,458 who used the drug (Maugh, Los Angeles Times, 6/11). Jennifer Niebyl, a professor of obstetrics and gynecology at the University of Iowa, said, "There are very few drugs approved for use in the first trimester of pregnancy. But this study could lead to metoclopramide getting approved to treat morning sickness because this is good data with big numbers" (Time, 6/10).~ Progesterone: The hormone progesterone was not effective at preventing premature births among women pregnant with twins, despite evidence suggesting its effectiveness at preventing premature births in single pregnancies, according to a University of Edinburgh study published in the journal Lancet, Reuters reports. Multiple pregnancies have a larger health risk for women and significantly increase the likelihood of miscarriage, premature birth and long-term health problems. The study involved 500 women who took either progesterone or a placebo daily for 10 weeks. Although previous studies have shown that progesterone might prevent premature birth in certain high-risk pregnancies, the new findings show the treatment did not reduce the likelihood of premature delivery or a fetus dying in utero in twin pregnancies. Twenty-five percent of women delivered or had a fetus die before 34 weeks in the progesterone group, compared with 20% in the placebo group (Kahn, Reuters, 6/10).
Cardiovascular

Mothers Lack Education On Infant Bottle-Feeding

A systematic literature review of mothers" experiences with bottle-feeding found that while mothers recognize the benefits of breastfeeding, those who bottle-feed with infant formula do not receive adequate information and support from their healthcare providers and thus, ultimately put their baby"s health at risk. "While it is important to promote breastfeeding," the authors conclude, "it is also necessary to ensure that the needs of bottle-feeding mothers are not overlooked." To help meet this need, the International Formula Council* (IFC) provides helpful online res, including video and print information that review the basics of safe infant formula preparation (available through the www.infantformula.org website). "One of our goals as an association is to help parents make informed infant feeding choices. Infant formula manufacturers have long provided their own brand-specific information on infant formula labels and websites. Our online tools build on these res and offer parents practical tips that help them prepare and store infant formula appropriately," said Mardi Mountford, IFC Executive Vice President. . The literature review - the first of its kind - appears in the July 2009 Archives of Disease in Childhood, a publication of the peer-reviewed British Medical Journal, and was conducted by researchers at the University of Cambridge. A major finding of the review, which examined 23 studies (seven from the United States, 14 from the United Kingdom, one from New Zealand, and one from Australia) with over 13,000 participants, was that mothers who did not receive bottle-feeding information from their healthcare providers often turned to family and friends for guidance - a trend which can perpetuate errors in infant formula preparation and handling. Infant formula manufacturers are required by law to provide clear and explicit information about the proper mixing, handling and storage of their products. But mothers also need to have that information reinforced by members of the healthcare community, to ensure the instructions are understood. The researchers discovered that without appropriate education, mothers may be making mistakes. "Such errors and other variations in formula-feeding may have both short- and long-term health consequences," the study authors report. The researchers also note that despite differences among the studies, a common thread remained throughout - mothers who bottle-fed their infants were riddled with negative feelings of inadequacy, guilt, and failure. As Lillian Beard, MD, a practicing pediatrician for more than 30 years, can attest, "While breastfeeding should be encouraged, it is not the only safe and nutritious infant feeding option available. Healthcare providers should counsel new moms with information on all infant feeding options in order to ensure the health of their babies as well as support mothers in their decision." The findings by the UK researchers coincide with those seen recently in the United States: * Last year, a study by the Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) found that 77 percent of mothers did not receive information on infant formula preparation from their healthcare provider. * Last month, a national U.S. survey on infant feeding found that 78 percent of mothers believe new moms should receive information on breastfeeding and other feeding options so they can make an informed choice and mothers should not have the information they receive restricted. In the same poll, mothers said that above all, they want information, flexibility and choice when it comes to infant feeding decisions. According to another CDC study, nearly 80 percent of all babies born in the U.S. are breastfed at birth. Yet, for those mothers who cannot or choose not to breastfeed, research shows these mothers not only want information on bottle-feeding, but are in great need of education to ensure optimal health for their infants. "As a health professional, I am committed to breastfeeding and the incomparable value of mother"s milk for her infant," adds Dr. Beard. "However, in instances where breast milk is not available, infant formula remains the only safe and nutritious alternative to promote the infants" healthy growth and development. We in the healthcare community have a responsibility to provide information to ensure that parents who choose to give formula to their babies understand and appreciate the importance of safe preparation, handling, and storage of all infant formula." For additional information and infant feeding safety tips, visit http://www.infantformula.org/forparents.html. *The IFC is an association of manufacturers and marketers of formulated nutrition products, e.g., infant formulas and adult nutritionals, whose members are based predominantly in North America. Marisa Salcines Kellen Communications


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