Update 1: Regulators Suggest Restricted Use of Drug
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British regulators recommended Monday that physicians restrict the use of the anti-depressant Efexor because its use could have side effects for heart health and pose other risks that require more careful monitoring than its competitors.
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The U.S. Food and Drug Administration is facing new questions about its ability to police the safety of medicines after they reach the market following concerns about a widely used diabetes drug.
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SOME of Britainâs most popular medicines are to be reviewed by drug regulators after claims by an American scientist that they pose severe risks to patients and should not be prescribed.
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BETHESDA, Md.  - A U.S. advisory panel on Friday  urged regulators to reject over-the-counter sales of Merck &  Co. Inc.'s cholesterol-lowering drug Mevacor because of doubts  the medicine could be used safely without a doctor's guidance.
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The federal Food and Drug Administration&#39;s ability to protect the American public is in question in the wake of the problems with this year&#39;s flu vaccine shortage and claims that it is allowing unsafe drugs to remain on the market.
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British regulators recommended that physicians restrict the use of the anti-depressant Efexor because its use could have side effects for heart health and pose other risks that require more careful monitoring than its competitors. The drug's manufacturer, Wyeth, said it would challenge the decision, but its shares slipped 3 percent.
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The US Food and Drug Administration is recommending physicians limit prescriptions for popular painkillers known as Cox-2 inhibitors after recent studies suggested they may increase the risk of heart attacks and strokes.
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Nearly 20 percent of U.S. Food and  Drug Administration scientists surveyed in late 2002 said they  were pressured to approve or recommend approval of a medicine  despite their reservations about the drug's risks or  effectiveness, according to documents made public on Thursday.
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Common children's cold and cough medicines are coming under scrutiny from federal drug regulators, who say the remedies and their recommended doses have not been studied enough in children, a newspaper reported.
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The US Food and Drug Administration is considering further regulatory measures, including withdrawal from the market, of Pfizer&#39;s arthritis treatment Celebrex.
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The Food and Drug Administration is considering allowing pharmaceutical makers to provide doctors with medical journal studies of unapproved uses for drugs, a move critics say would undermine long-standing restrictions on marketing medicines for "off-label" purposes.
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Government regulators now look to approve as quickly as possible medicines whose benefits exceed their risks.
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British regulators recommended on Monday that physicians restrict the use of the anti-depressant Efexor from drugmaker Wyeth because its use could have side effects for heart health and pose other potential risks that require more careful monitoring than
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U.S. health officials Thursday called on doctors to limit prescribing Pfizer Inc. painkillers Celebrex and Bextra in light of recent evidence that they may increase the risk of heart attack and stroke.
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Roche Holding AG and GlaxoSmithKline said on Wednesday they asked U.S. regulators to approve an intravenous form of their osteoporosis drug that could be administered far less frequently.
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Employees will be subject to stringent new restrictions on stock holdings, outside consulting, and other forms of income from drug companies under new regulations to take effect this week.
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The Food and Drug Administration expects to seek tougher measures regulating the use of antidepressants when it convenes an advisory panel meeting next month, according to agency documents released yesterday.