FDA Strengthens Warning on Mifepristone
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FDA on Monday announced that it will revise the &quot;black box&quot; warning for Danco Laboratories&#39; Mifeprex, a drug taken to induce a medical abortion, in response to numerous reports of infection, bleeding and death among women who have taken the drug, the San
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The federal Food and Drug Administration approved new labeling Thursday for Pfizer Inc.&#39;s Bextra drug to warn of possible serious skin reactions and heart-related problems for those who&#39;ve experienced coronary bypass surgery.
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The US Food and Drug Administration announced Monday that a strong new warning will be issued for the medical-abortion drug known as RU-486, citing the risk of &quot;rare but serious complications that may occur with any abortion.
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Nov. 16, 2004 -- The FDA has strengthened warning labels for the controversial abortion pill Mifeprex, better known as RU-486, following an August report of a 22-year-old woman who died after taking the drug.
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The Food and Drug Administration on Friday ordered that all antidepressants carry "black box" warnings that they "increase the risk of suicidal thinking and behavior" in children who take them.
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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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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 a medication guide for patients to advise them of the risk...
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When taken within five days after unprotected sex, mifepristone works as well for emergency contraception as the approved drug levonorgestrel, UK researchers report.
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Consumer watchdog group Public  Citizen expanded its drug safety Web site worstpills.org on  Wednesday to include more warnings about side effects, drug  interactions and inadequate research.
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The US Food and Drug Administration on Wednesday ordered a strong, new warning for Pfizer Inc.&#39;s injectable contraceptive called Depo-Provera, saying it could permanently weaken bones.
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The U.S. Food and Drug  Administration plans to update antidepressant labels to reflect  studies that suggest a link between the drugs and suicide in  youths, despite remaining cautious about the strength of such  ties, the agency said on Friday.
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OTTAWA - Health Canada said it will issue a new warning about the painkiller Bextra as regulators in the US said they were strengthening warnings about the drug.
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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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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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WASHINGTON -- An abortion pill implicated in the death of an 18-year-old California woman last fall will add new warnings linking RU-486 to the risk of serious bacterial infection.
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With new warnings on an abortion pill, the Food and Drug Administration has given conservative medical advice. Whatever factors may have gone into the change, the FDA must focus on science, not conservative politics.
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Abbott Laboratories Inc. added  several new warnings to the label for its rheumatoid arthritis  drug Humira, according to a company letter released on Monday.