FDA to recheck safety of drug trials
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The Food and Drug Administration yesterday called for an evaluation of all prevention studies involving two controversial painkillers - Celebrex and Bextra - to ensure adequate protection for participants who use the pills.
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The Food and Drug Administration will examine clinical trial data for thousands of depressed adults to see if they, like children, suffered increased suicidal thoughts and behaviors while taking antidepressants.
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The Food and Drug Administration yesterday ordered a review of all prevention studies involving drugs such as Celebrex and Bextra, which have been associated with increased risk of heart problems. The agency also urged the public to limit use of over-the-counter pain medications.
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The US Food and Drug Administration on Thursday ordered the review of preventative studies involving Pfizer Inc.&#39;s painkillers Celebrex and Bextra, in light of recent evidence they may increase the risk of heart attack and stroke.
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WASHINGTON -- The Food and Drug Administration will examine clinical trial data for thousands of depressed adults to see if they, like children, suffered increased suicidal thoughts and behaviors while taking antidepressants.
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The pharmaceutical industry made a commitment Thursday to publish more data about clinical drug trials, amid growing questions about the safety of many leading companies' medicines.
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European drug regulators are conducting a safety review of four arthritis drugs amid reports that they could increase the risk of strokes and heart attacks.
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U.S. regulators said on Friday they would review a study showing a Merck and Schering-Plough cholesterol drug worked no better than a generic in preventing the build-up of arterial plaque.
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The U.S. Food and Drug Administration said on Tuesday it would make organizational changes to improve internal communication about potential risks that emerge after a new drug reaches the market.
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WASHINGTON - The Food and Drug Administration (news - web sites) will examine clinical trial data for thousands of depressed adults to see if they, like children, suffered increased suicidal thoughts and behaviors while taking antidepressants.
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ROCKVILLE, Md.  - The U.S. Food and Drug  Administration will ask the Institute of Medicine to study the  agency's safety monitoring of medicines already on the market,  Acting FDA Commissioner Lester Crawford said on Friday.
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As expected, FDA officials on Friday announced plans to improve the procedures used by the agency to monitor the safety of medications after they reach the market, the Newark Star-Ledger reports.
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Medicines watchdogs are reviewing safety data for an entire class of drugs taken by millions of patients with arthritis and severe pain after the worldwide withdrawal of Merck&#39;s Vioxx last week.
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Just as the Enron scandal triggered an overhaul of corporate accounting practices, the nation's prescription drug crisis may prompt a sweeping revamp of the way the Food and Drug Administration ensures drug safety, some say.
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The public should have reasonable expectations that medicines the Food and Drug Administration has approved for the market are, in fact, safe.
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Nov. 5, 2004 -- FDA officials announced Friday that they will launch a review of the agency&#39;s drug monitoring policies in the wake of recent high-profile safety concerns about widely used drugs, including antidepressants and Vioxx.
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FRIDAY, Nov. 17 (HealthDay News) -- Just-released data from a trial that was stopped early in 2004 for safety reasons is re-igniting debate on the safety of two popular painkillers.