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 Safety Information - August 28, 2008
| A Food and Drug Administration advisory committee on Tuesday declined to recommend a drug intended to treat prostate cancer, after a report questioned its safety and effectiveness. Abbott Laboratories presented Atrasentan, shelved under the name Xinlay, as a treatment for men with an advanced stage of prostate cancer that spreads to the bone. The FDA's Oncologic Drugs Advisory Committee, however, voted unanimously against its recommendation | | The Food and Drug Administration did not issue a safety alert about Guidant's heart devices until five months after it was warned about problems with the product, according to a New York Times article Monday. As early as February, the FDA received data showing the Indianapolis-based company's defibrillator product, the Ventak Prizm 2 DR, was short-circuiting. However, the FDA did not announce a recall of the device until July 1 | | Diabetics across the nation can be heard cheering Sunday as the Food and Drug Administration passes an inhaled Insulin treatment, an alternative to the daily shot routine that millions have to do on a daily basis. The panel voted by seven to two to recommend approving the product, called Exubera, on the grounds that its advantages in terms of ease of administration and its potential to improve patient compliance outweighed lingering doubts about its safety | | A government advisory committee is keeping a close eye on an inhaled form of insulin, designed to help millions of people with diabetes who currently rely on injections to control their blood sugar. According to documents released by the Food and Drug Administration, chief concerns involve long-term effects on the lungs, as well as the safety of its use among smokers or sufferers of lung disease | | A government advisory committee is keeping a close eye on an inhaled form of insulin, designed to help millions of people with diabetes who currently rely on injections to control their blood sugar. According to documents released by the Food and Drug Administration, chief concerns involve long-term effects on the lungs, as well as the safety of its use among smokers or sufferers of lung disease | |
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