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 FDA Information - October 6, 2008
| Bisphenol A (BPA), the most controversial chemical widely used in baby bottles, plastic food and drink containers, has been linked for the first time with increased rates of heart disease, diabetes and liver abnormalities in adults. A team of British toxicologists analysed findings from an American survey of 1,455 adults and found that adults with the highest concentrations of BPA in their urine had nearly triple the odds of cardiovascular disease, compared with those with the least amounts of the compound in their systems | | The U.S. Food and Drug Administration (FDA) on Tuesday said it would block the import of more than 30 generic drugs made at two factories run by India-based Ranbaxy Laboratories because the company failed to meet safety and contamination standards for manufacturing drugs. <p>However, the federal agency said there are no reports that consumers have been harmed by unacceptable production by the said laboratory and it is not issuing a recall of Ranbaxy-made generic drugs. It urged patients who take the banned medicines to continue taking them rather than stop without a doctor's recommendation, which could be dangerous | | Sancuso, a five-day patch that fights nausea from cancer chemotherapy, has won a federal approval in the United States. The patch is worn on the arm and delivers a widely used anti-nausea medicine, known as granisetron, through the skin, Galashiels, UK-based pharmaceutical company ProStrakan said. Nausea is a common side effect of chemotherapy that many patients face. Some patients have to prematurely stop their cancer treatment because of severe nausea and vomiting. Sancuso blocks serotonin receptors and helps prevent nausea. The only side effect in the clinical trial of this patch was constipation | | The Food and Drug Administration approved Friday Merck & Co.'s cervical cancer vaccine, Gardasil, for the prevention of vulvar and vaginal cancer. Gardasil, which was FDA-approved in 2006 as vaccine against the human papillomavirus or HPV, also protects against cancers of the vagina and vulva, which inflicts over 5,000 women in the U.S. annually, according to Merck | | Federal health regulators have approved Merck and Co's HPV vaccine Gardasil to protect against rare vaginal and vulvar cancers in girls and women ages 9-26. Gardasil, which targets four strains of the human papillomavirus (HPV) that cause most cases of cervical cancer, is already approved to help prevent a leading cause of cervical cancer in women of that same age range. Two of those HPV strains can also cause some vulvar and vaginal cancers | |
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