F.D.A. Orders Warnings on Anemia Drugs
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The move follows recent studies suggesting that the medications might cause heart attacks or make cancer worse in some patients.
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The F.D.A. has begun to crack down on the thousands of drugs, often made by small companies, that have never had to go through the agencyâs stringent approval process.
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WASHINGTON - Federal health advisers considering more stringent warning labels for antidpressants linked to suicidal thoughts among children told the Food and Drug Administration on Tuesday that they may consider more than just a label change.    One member of the panel asked the drug agency whether they could require that those prescribing the drugs undergo training to better recognize warning signs...
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A leading diabetes doctor sent the Food and Drug Administration a letter seven years ago that warned of the heart risks of the drug Avandia.
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The Food and Drug Administration is now warning about heart risks related to the use of naproxen, a long-time popular pain killer sold over the counter, as well as a prescription-strength medication sold under various names.
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Anemia drugs sold by Amgen Inc. and Johnson & Johnson will carry a new boxed warning advising doctors to choose the lowest dose needed to avoid blood transfusions, the U.S. Food and Drug Administration said on Friday.
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WASHINGTON -- The Food and Drug Administration warned consumers yesterday not to buy or use the supplements Actra-Rx or Yilishen because they contain an ingredient that could lower blood pressure to unsafe levels.
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Federal health officials are warning doctors that certain types of metallic dye injected for MRI scans have been linked to a rare and dangerous skin disease in kidney patients.
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A pair of Food and Drug Administration advisory panels called yesterday for new warnings for the widely used diabetes drug Avandia because of evidence that it significantly raises the risk of heart attack, but they stopped short of recommending that the drug be pulled from the market, as some FDA...
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The dangers of over-the-counter painkillers will be prominently highlighted on the labels under a new proposal by the F.D.A.
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Another arthritis drug was at the centre of an alert today after US officials updated warnings on their labelling. Centocor, a subsidiary of Johnson &amp; Johnson
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The U.S. Food and Drug  Administration on Wednesday ordered a strong, new warning for  Pfizer Inc.'s PFE.N injectable contraceptive called  Depo-Provera, saying it could permanently weaken bones.
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Amgen Inc. has added a warning to its anemia drug, Aranesp, for kidney dialysis and cancer patients after studies on similar drugs showed higher doses can cause blood clots and death, the company said a letter released on Friday.
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Bristol-Myers Squibb  has strengthened its warning about the risk of possible fatal bleeding linked to its blood thinner drug, Coumadin, adding a black box to its label, U.S. health officials said on Friday.
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U.S. health officials on Tuesday proposed new warnings about liver and stomach risks on the labels of over-the-counter pain relievers such as aspirin, ibuprofen and acetaminophen.
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An expert panel advising the Food and Drug Administration recommended today that antidepressants carry a warning in a black box on the label saying that the medications
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The U.S. Food and Drug Administration on Wednesday ordered a strong, new warning for Pfizer Inc.'s  injectable contraceptive called Depo-Provera, saying it could permanently weaken bones.