FDA Denies Trying to Block Vioxx Results
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The U.S. Food and Drug Administration denied charges it tried to suppress a safety official's findings that painkiller Vioxx, which was pulled from the market last week, raised heart attack risks.
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Merck failed to warn doctors about the risks of its painkiller Vioxx and must pay a retired FBI agent $50 million to compensate for the heart attack he suffered after taking the drug, a federal jury found Thursday.
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A federal judge denied a request by Pfizer (nyse: PFE - news - people ) to halt competitors&#39; sales of gabapentin, a generic form of Pfizer&#39;s Neurontin epilepsy drug.
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A Food and Drug Administration official who sought to estimate the harm done to patients by side effects of the painkiller Vioxx said yesterday that his supervisors tried to suppress his conclusions, according to Sen.
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Congress has been investigating the FDA&#39;s decisions in both the Vioxx and antidepressant cases. The probes have focused on agency reviewers who warned about potential problems but claimed their research was ignored or suppressed by other officials.
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A top official of the US Food and Drug Administration said Friday that he and his colleagues &quot;categorically reject&quot; earlier Congressional testimony that the agency has failed to protect the public against dangerous drugs.
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The Food and Drug Administration yesterday again denied the agency had any early indications that there were serious problems at a British vaccine company that was supposed to supply half of the US flu vaccine.
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The U.S. Food and Drug Administration failed the public in its oversight of Merck & Co Inc.'s painkiller Vioxx, which has been withdrawn, and is "incapable of protecting America" from another dangerous drug, an agency researcher told Congress on Thursday.
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The American public is &quot;virtually defenseless&quot; if another medication such as Vioxx proves to be unsafe after it is approved for sale, a government drug safety reviewer told a congressional committee Thursday.
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The Food and Drug Administration told Merck &amp; Co. that it requires further safety and efficacy data before it will approve its successor drug to now defunct pain reliever Vioxx, the pharmaceutical maker announced Friday.
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A U.S. federal judge has denied motions to certify classes of users of osteoporosis drug Fosamax who wanted Merck & Co  to set up a program to monitor them for an ailment involving jaw bone decay.
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Merck officials had evidence far back as 2001 that Vioxx might not help thousands of users of the arthritis and pain drug.
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WASHINGTON - The Food and Drug Administration silenced one of its drug experts who raised safety concerns weeks before Merck & Co. yanked the blockbuster drug Vioxx due to increased risks for heart attack and strokes, the chairman of the Senate Finance Committee said Thursday...
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A drug manufacturer and the Food and Drug Administration failed the public by not heeding the warning signs associated with Vioxx, and Congress should investigate their actions, a Cleveland Clinic cardiologist said Wednesday.
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Food and Drug Administration approval of a drug label does not clear the manufacturer of claims that its warnings were inadequate, a judge ruled.
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Industry analysts are predicting US regulators this month will refuse to approve Merck &amp; Co.&#39;s new arthritis drug until at least 2006 because of heart attacks linked to its recalled sister drug Vioxx.
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The Food and Drug Administration ignored danger signals from its own scientists about Merck and Co. Inc.'s Vioxx painkiller, Sen. Charles Grassley told a hearing Thursday into the drug's withdrawal in September.