Word: fda
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Dates: during 2000-2009
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Doctors will probably still find reasons to give injections, but a new drug-delivery system approved by the FDA could take the pain out of at least some of them. The device, called the SonoPrep, developed by researchers at M.I.T. and Israel's Ben-Gurion University, delivers medication through tiny pores in the skin. It uses ultrasound waves to create temporary microchannels in the skin through which drugs can pass. The device was approved as a way to anesthetize the skin with lidocaine cream to prepare patients, especially children, for painful procedures like the insertion of catheters and IV lines...
...hour and costs $3,000 to $4,000 per eye. In a company-sponsored study, 92% of 662 patients who got the Verisyse lens had 20/40 or better vision after three years; 44% tested 20/20. But patients also showed a steady loss of cells in the cornea, and the FDA has asked for a five-year follow-up study to track long-term effects...
...cure for depression worse than the illness? The Food and Drug Administration’s (FDA) advisory committee recently answered in the affirmative in their recommendation to brand antidepressants with a “black box” warning label. Apparently, antidepressants and youth depression don’t mix; studies have documented a minimal increase in suicidal thoughts among children and adolescents taking prescribed antidepressants compared with those taking a placebo. This is worrisome indeed—not for the two or three percent on antidepressants who would experience heightened thoughts and ideas of suicide, but for the tens...
...they are based, ultimately dissuading practitioners and parents alike from considering antidepressants can only do harm—especially when the present uproar is not even based on actual suicides. This is exactly what the chosen labels, which are the most cautionary and daunting of any issued by the FDA, have already begun to accomplish...
...there may be risks. The U.S. Food and Drug Administration (FDA) issued a firm warning earlier this year in its consumer magazine. Although there are no reported cases of ultrasound causing harm to a fetus, the FDA says we simply don't know enough about the long-term effects of repeatedly sending high doses of energy across a mother's womb. After all, these ultrasonic waves are the same as those used at higher exposure to break up kidney stones. Laboratory studies have shown that even at low levels, ultrasounds can produce physical effects in tissue, including jarring vibrations...