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...also an important one-and not just for Big Pharma's balance sheets. In the wake of the Vioxx withdrawal, many arthritis sufferers have turned to drugs in the ibuprofen and naproxen families, such as Advil and Aleve. But earlier this year the Food and Drug Administration (FDA) announced that those drugs may also carry cardiovascular risks; in any event, for some people they just don't pack the same pain-relieving punch. Others patients are relying on oxycontin and morphine-based medications, which may not endanger the cardiovascular system in the same way, but carry perils of their...
...idea here is if you know what happens in the highest risk individuals, you will know how to use the drugs in people at lower risk," said Nissen, who served on an FDA panel which last February recommended just such a study. "We will have 10 times the statistical power of any study ever done of these drugs." The results may thus indeed finally answer any lingering questions about how safe Celebrex is, something Pfizer no doubt hopes-but also fears...
...VACCINES If all goes well, the FDA could approve the first vaccine for cervical cancer by 2006. A large-scale study presented at a meeting of the Infectious Diseases Society of America in October found that Merck's experimental vaccine Gardasil was 100% effective against two strains of human papillomavirus that cause 70% of all cervical cancers. Another experimental Merck vaccine was tested this year for protection against shingles, the painful blistering disorder caused by the chicken-pox virus. In a trial of more than 38,500 adults 60 and older, the vaccine cut the risk of shingles by more...
...year study of milk-drinking men, is to switch to low- or nonfat dairy products. Another is to stay below a body mass index of 30; exceeding that number can almost double a man's chances of developing diabetes, according to the American Journal of Clinical Nutrition. Meanwhile, the FDA approved the smallest diabetes testing system available, Sidekick, to join the list of recently developed tools for diabetics, including blood-sugar monitors with less painful laser lancets and nasal sprays and inhalers for delivering insulin...
BBW’s are the strongest warning labels, given to high-risk medications by the FDA. They are used to indicate drugs that are associated with what Wagner described as “special problems, particularly those that may lead to death or serious injury.” The warnings themselves are printed in a black frame in a package insert for the drugs. According to Wagner, these warnings are the FDA’s primary means of communicating risks to prescribers...