F.D.A. Issues Strictest Warning on Diabetes Drugs
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The agency has called for the toughest safety warning on Avandia and Actos, whose health risks have become a focus of concern.
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The US Food and Drug Administration (FDA) defended its approval of five prescription medications which a staffer dubbed unsafe when he warned the drugs present possible risks so severe they should face tougher restrictions or be pulled off the market.
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WASHINGTON - All antidepressants must carry a "black box" warning, the government's strongest safety alert, linking the drugs to increased suicidal thoughts and behavior among children and teens taking them, the Food and Drug Administration said Friday.    Because the warnings are primarily seen by doctors, the agency also is creating an information guide for patients to advise them of the risk...
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Food and Drug Administration officials are pushing for a "black box" warning on GlaxoSmithKline Plc's hard-hit diabetes drug Avandia, the Wall Street Journal reported, citing sources.
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Federal health officials issued stern new warnings Friday for doctors to more carefully prescribe widely used anemia drugs that can increase the risk of death and other serious problems in patients with cancer and kidney disease.
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-- The government's own preliminary evaluation of the diabetes pill Avandia confirms the heart risks reported in a study earlier this week and suggests that as many as 60,000 to 100,000 heart attacks might be linked to its use since it came on the market eight years ago, a leading member of Congress...
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A drug used to treat diabetes also seems to prevent it in people at high risk of developing the disease, the largest study ever to test this has found.
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A U.S. Food and Drug Administration preliminary analysis found a level of heart-attack risk with GlaxoSmithKline Plc'sdiabetes drug Avandia similar to what was reported in a study earlier this week, the agency confirmed on Friday.
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A top Food and Drug Administration  official said on Thursday she disagrees with an agency  scientist's warning that five drugs on the market have  significant safety risks.
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A newer drug appeared to delay the progression of the most common form of diabetes a little longer than two older medications but also raised the risk of heart problems, weight gain and fractures, a large study has found.
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Millions of adults at high risk of diabetes could ward off the disease by taking a drug commonly used to treat it, according to the largest diabetes prevention study yet conducted.
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A report last week tying the Type 2 diabetes pill Avandia to increased risk for heart attack and heart-related deaths prompted a flood of calls to local doctors and Internet postings from patients seeking advice about whether to continue taking the commonly prescribed medication.
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The U.S. Food and Drug  Administration needs to more closely regulate  direct-to-consumer advertising of prescription drugs, the  Government Accountability Office said on Thursday.
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FDA commissioner Andrew von Eschenbach took a tongue-lashing from members of Congress over the way his agency handled Avandia, the diabetes drug from GlaxoSmithKline that has come under scrutiny for alleged heart attack risks.
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Patients with diabetes,  especially women, who take thiazolidinediones, which include  commonly prescribed drugs such as Avandia and Actos, may have  an increased risk of developing cancer, according to a new  report.
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A top Food and Drug Administration official said on Thursday she disagrees with an agency scientist's warning that five drugs on the market have significant safety risks.
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Diabetics should receive cholesterol-busting drugs regardless of their heart disease risk, researchers say.