Word: fda
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...Halcion is facing its most serious challenge yet. Last week the British Department of Health banned sales of the drug in Britain, citing new evidence that the pill "is associated with a much higher frequency of side effects, particularly memory loss and depression," than similar medications. Soon afterward, the FDA promised to take a much closer look at the drug...
Physicians cannot prevent patients from taking more tablets than instructed. But following all the publicity about the abuse of Valium in years past, doctors should be more alert to the dangers of overreliance on tranquilizers and sleeping pills. Even if the FDA does not find the evidence against Halcion strong enough to ban the drug, it should be used less cavalierly...
...FDA just says no to a touted Alzheimer's drug...
...Lambert, which has U.S. marketing rights to the drug, a National Institute on Aging study of 200 patients at 16 hospitals found that among those receiving tacrine, more than 40% showed some improvement in performing mental or physical tasks. Based on this and other data, the company asked the FDA last March for approval to market tacrine as the first drug treatment for Alzheimer...
After that request was rejected by the FDA's advisory panel, the agency suggested that Warner-Lambert apply for more limited marketing, the strategy used to release the AIDS drugs. Under the plan reviewed last week, up to 50,000 patients would have been given the drug under close scrutiny. But the advisory panel's vote on lack of efficacy made the plan moot for now. "There was concern that a very bad precedent could be set if the scientific standards were lowered," says Steven Ferris, a neurobiologist at New York University Medical Center, who chaired the committee. The group...