FDA puts black box warning on bowel-clearing drugs

published 1 year, 7 months ago, submitted by maria 1 year, 7 months ago

news.yahoo.com — Federal health officials said Thursday they will add the sternest safety warnings available to prescription drugs used to cleanse the bowel before colonoscopies. The Food and Drug Administration said it has received more than 20 reports of a rare but serious form of kidney failure among patients taking the drugs, known as oral phosphate products. The new boxed warning label will apply to Visicol and OsmoPrep — both prescription tablets made by Salix Pharmaceuticals. The label warns that the drugs should be used with caution in older patients, those that suffer from dehydration and kidney disease or those that take medications that affect the kidneys. read more...

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School-Based Program Can Change Kids' Lives

published 1 year, 7 months ago, submitted by stef718 1 year, 7 months ago

news.yahoo.com — Urban kids who took part in a social development program in elementary school had improved mental health, sexual health, and educational and economic success as young adults, a new study finds. Crime, drug use, teen pregnancy, school dropouts and mental health problems are among the challenges faced by many children and families who live in cities, noted study author J. David Hawkins and colleagues at the University of Washington, Seattle. "Public schools, available to all children in the United States beginning at age 5 or 6 years, are a potentially powerful setting for preventive intervention," wrote the researchers. They examined the long-term impact of a prevention program, called the Seattle Social Development Project. When the project was launched in 1981, it included some first-grade students in elementary schools. It eventually expanded to 15 elementary schools in diverse neighborhoods. Parents, teachers and students received special instruction in areas such as behavior management, refusal, social skills, and academic development. read more...

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Gov't seizes more contaminated heparin

news.yahoo.com — WASHINGTON – Federal agents Thursday seized quantities of a contaminated blood thinner made in China from a small manufacturer in Cincinnati, officials said. The blood thinner heparin, given to patients undergoing heart surgery and kidney dialysis, was the focus of a major recall earlier this year after crude drug material from China was found to be contaminated. Hundreds of frail patients suffered severe allergic reactions. The government received reports of nearly 250 deaths. The FDA had inspected the Cincinnati company, Celsus Laboratories, Inc., in April and at the time found contaminated heparin in two different kinds of products, officials said. A little over 2 pounds of the blood thinner was intended for use directly with patients, and another 31 pounds was to be utilized in diagnostic test kits and medical devices. The FDA seized the heparin after informing the company that its efforts to notify customers of the contamination problem were unsatisfactory, the agency said in a statement. Drug seizures are a rare penalty for the FDA, since regulators prefer to negotiate with manufacturers to resolve disputes. read more...

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Despite failures, search for anti-obesity drugs still looks golden

published 1 year, 8 months ago, submitted by gregmax 1 year, 8 months ago

news.yahoo.com — PARIS (AFP) – Designers of anti-obesity drugs have suffered three major setbacks, but the potential reward from treating the world's fat epidemic is so great that their quest is unlikely to be deterred. After investing a sum rumoured to be in the hundreds of millions of euros (dollars), Sanofi-Aventis of France announced last Wednesday it was abandoning its drug rimonabant, which had stoked huge expectations at its launch in 2006. Rimonabant -- brand name Acomplia -- ran into a flurry of ever-tougher warnings from European watchdogs about potential psychiatric side effects, including depression. read more...

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'Prescription Switching' Would Make Most Patients Unhappy

news.yahoo.com — Most prescription drug users would be unhappy if one of their medications was switched to another in the same class without their knowledge or their doctor's approval, a new survey shows. The practice, known as therapeutic substitution, is usually done as a cost-saving measure. "People may not know about it, but it's happening, and if it is happening, it should be happening with full transparency, and patients and doctors should be in on this," said Sally Greenberg, executive director of the National Consumers League. "It's not necessarily something that we're condemning." But others feel the practice is not unduly widespread and, even when it is used, that doctors and patients rarely go uninformed. read more...

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Older Blood Used in Transfusions Raises Infection Risk

healthnews.com — Most of us don’t think about blood. We just want it to stay where it belongs and do its job. Blood is the body’s transportation system, carrying oxygen and nutrients to the organs in our body that need them, and carrying away the waste products to be eliminated. In an average lifetime most people will never need a blood transfusion. The business of blood, donations, storage, and transfusion, is regulated by the Food and Drug Administration. Blood cannot be used for patients if it has been stored over 42 days but recent findings may indicate that is too long. According to Cooper University Hospital in New Jersey, after 29 days of storage, the risk of blood poisoning or pneumonia doubled in recipients. The possible reason is that after two weeks in storage the red blood cells in the blood start to undergo changes and begin to release chemicals call “cytokines.” The cytokines hinder immune function and high levels could make patients more susceptible to infection. read more...

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Gov't seizes more contaminated heparin

published 1 year, 8 months ago, submitted by gregmax 1 year, 8 months ago

news.yahoo.com — Federal agents Thursday seized quantities of a contaminated blood thinner made in China from a small manufacturer in Cincinnati, officials said. The blood thinner heparin, given to patients undergoing heart surgery and kidney dialysis, was the focus of a major recall earlier this year after crude drug material from China was found to be contaminated. Hundreds of frail patients suffered severe allergic reactions. The government received reports of nearly 250 deaths. The FDA had inspected the Cincinnati company, Celsus Laboratories, Inc., in April and at the time found contaminated heparin in two different kinds of products, officials said. A little over 2 pounds of the blood thinner was intended for use directly with patients, and another 31 pounds was to be utilized in diagnostic test kits and medical devices. The FDA seized the heparin after informing the company that its efforts to notify customers of the contamination problem were unsatisfactory, the agency said in a statement. Drug seizures are a rare penalty for the FDA, since regulators prefer to negotiate with manufacturers to resolve disputes. A representative who answered the phone at Celsus said the company would have no comment. read more...

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Bayer Products Questioned by the FDA

healthnews.com — Bayer has been given fifteen days by the FDA to take action regarding allegations that the company is marketing and selling two aspirin products that have not been given FDA approval. The company has been told to comply by either ending sales of their Bayer Aspirin with Heart Advantage and Bayer Women’s Low Dose Aspirin plus Calcium or to proceed with clinical trials, in order to gain the required FDA approval. The German company manufactures the Heart Advantage product, which is aspirin with a plant extract called phytosterois, that the company claims on the products label has been proven to help lower cholesterol, and Bayer’s Women’s Low Dose Aspirin, aspirin combined with calcium carbonate that the company states on the label helps to fight osteoporosis. read more...

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