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WASHINGTON, March 4 (Xinhua) -- New data suggest that the epilepsy drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy, the U.S. Food and Drug Administration (FDA) said Friday in a statement.Before prescribing topiramate, approved to treat certain types of seizures in people who have epilepsy, health care professionals should warn patients of childbearing age about the potential hazard to the fetus if a woman becomes pregnant while using the drug, the FDA said.Topiramate also is approved to prevent migraine headaches, but not to relieve the pain of migraines."Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age," said Russell Katz, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "Alternative medications that have a lower risk of birth defects should be considered."Cleft lip and cleft palate, collectively called oral clefts, are birth defects that occur when parts of the lip or palate do not completely fuse together early in the first trimester of pregnancy, a time when many women do not know they are pregnant.The defects range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, possibly leading to problems with eating, talking, and to ear infections. Surgery often is performed to close the lip and palate and most children do well after treatment.Data from the North American Antiepileptic Drug (AED) Pregnancy Registry indicate an increased risk of oral clefts in infants exposed to topiramate during the first trimester of pregnancy. Infants exposed to topiramate as a single therapy experienced a 1.4 percent prevalence of oral clefts, compared with a prevalence of 0.38 percent - 0.55 percent in infants exposed to other antiepileptic drugs.Infants of mothers who did not have epilepsy and were not being treated with other antiepileptic drugs had a prevalence of 0.07 percent. Similar data from the United Kingdom Epilepsy and Pregnancy Register supported the North American AED Pregnancy Registry data.According to the FDA, before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their health care professional.
HOUSTON, May 2 (Xinhua) -- The Offshore Techonology Conference, one of the world's largest offshore technology shows, kicked off here Monday.The five-day event, which attracted an estimated 72,000 victors from all around the world, not only provided a platform for the about 2,400 participating companies from 40 countries to lure visitors with their newest products and technologies, but also for the them to share insights and discuss issues the industry is facing.On Monday, a number of companies, including Halliburton and Baker Hughes, received the Spotlight on New Technology Award by the OTC for their new products and solutions.Founded in 1969, the annual Offshore Technology Conference is the world's foremost event for the development of offshore resources in the fields of drilling, exploration, production, and environmental protection. OTC is held annually at Reliant Center in Houston.
CHANGCHUN, Jan. 22 (Xinhua) -- Chinese Vice President Xi Jinping stressed political integrity as the most important criteria in electing Communist Party cadres, during his three-day inspection tour in northeast Jilin province, which ended Saturday.The standards of political integrity and professional competence, with the former being the most important, should be strictly observed in the upcoming election of the new term for Party Committee members at provincial, city, county and township levels, Xi, a Standing Committee member of the Communist Party of China (CPC) Central Committee Political Bureau, said.During his meeting with leaders of the provincial Party Committee and provincial government of Jilin, Xi said efforts should be made to reinforce the notion of putting people first and exercising the state power for the people among carders.Chinese Vice President Xi Jinping (2nd L front) talks with a staff member at a workshop of FAW car factory in Changchun, capital of northeast China's Jilin Province, Jan. 21, 2011. Xi made an inspection tour in Jilin from Jan. 20 to 22.While visiting a community Party organization, Xi also asked grass-roots Party organizations to give priority to building a closer bond with the public and serving the public.During his visit to several companies, including Changchun-based First Automobile Works, Xi called for efforts to develop technology-intensive industries and the manufacturing of high-end products to promote economic restructuring.He also visited flood-hit areas to observe the relocation of flood victims and reconstruction work. Jilin Province was hit by unprecedented floods last July and August.He asked local governments to rebuild flood-damaged homes as soon as possible and repair those destroyed water conservancy projects and encourage farmers to grow crops on flooded lands.
LOS ANGELES, May 1 (Xinhua) -- Middle-aged adults who sleep too less or too much may be more likely to suffer cognitive decline, a new study suggests.According to the study, less than six hours of sleep each night is considered too little and more than eight hours as too much for middle-aged adults.The study, conducted by researchers at University College London Medical School, was published May 1 in the American medical journal Sleep.The researchers conducted the study in two periods -- the 1997- 1999 period and the 2003-2004 period. The participants were asked how many hours they slept on an average week night, and were asked the same question in 2003-2004 after an average 5.4 years of follow-up.The researchers compared those who reported changes in their sleep patterns with people whose sleep duration stayed the same over the course of the study.In the follow-up, each individual was given a battery of standard tests to assess his or her memory, reasoning, vocabulary, global cognitive status and verbal fluency.The study findings show that women who slept seven hours per night had the highest score for every cognitive measure, followed by those who had six hours of sleep. For men, cognitive function was similar for those who reported sleeping six, seven or eight hours.However, less than six hours of sleep -- or more than eight hours -- were associated with lower scores."Sleep provides the body with its daily need for physiological restitution and recovery," explained Jane Ferrie, a senior research fellow in the department of epidemiology and public health at the school. "While seven hours a night appears to be optimal for the majority of human beings, many people can function perfectly well on regular sleep of less or more hours."However, since most research has focused on the effects of sleep deprivation on biological systems, it is not yet fully understood why seven hours is optimal -- or why long sleeping appears to be detrimental, Ferrie said."Chronic short sleep produces hormones and chemicals in the body which increase the risk of developing heart disease and strokes, and other conditions like high blood pressure and cholesterol, diabetes and obesity," she added.
WASHINGTON, May 20 (Xinhua) -- The U.S. Food and Drug Administration (FDA) on Friday approved Sutent to treat patients with progressive neuroendocrine cancerous tumors located in the pancreas that cannot be removed by surgery or that have spread to other parts of the body.Neuroendocrine tumors found in the pancreas are slow-growing and rare. It is estimated that there are fewer than 1,000 new cases in the United States each year.This is the second new approval by the FDA to treat patients with this disease. On May 5, the agency approved Afinitor."FDA believes it is important to provide cancer patients with as many treatment options as possible," said Richard Pazdur, director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research. "The agency is committed to working with companies to bring innovative new therapies to the market and encourages companies to continue exploring additional uses for approved products."The safety and effectiveness of Sutent was established in a single study of 171 patients with metastatic (late-stage) or locally advanced (disease that could not be removed with surgery) disease who received Sutent or a placebo (sugar pill). The study was designed to measure the length of time a patient lived before their disease spread or worsened (progression-free survival).Results from the study demonstrate that Sutent provided benefit to patients by prolonging the median length of time they lived without the cancer spreading or worsening to 10.2 months compared to 5.4 months for patients who received placebo.In patients treated with Sutent for neuroendocrine pancreatic tumors, the most commonly reported side effects included diarrhea, nausea, vomiting, fatigue, anorexia, high blood pressure, energy loss, stomach pain, changes in hair color, inflammation of the mouth, and a decrease in infection-fighting white blood cells.Sutent is marketed by New York City-based Pfizer.