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TIME FOR VIOXX TO PAY! (supplement for 'vioxx killed my husband.'...
by Phylo

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  • Merck will get away with Murder if this blog doesn't contine. So my boo...   by  Phylo     17 y     2,382       2 Messages Shown       Blog: TIME FOR VIOXX TO PAY! (supplement for 'vioxx killed my husb
    FDA Scientist Questions Need for COX-2 Drugs

    By Susan Heavey and Lisa Richwine

    WASHINGTON (Reuters) Feb 17 - A veteran U.S. Food and Drug Administration scientist on Thursday said he saw no need for COX-2 inhibitors, citing increased vascular risks.
    The presentation by David Graham, associate director for science and medicine at the FDA's Office of Drug Safety, came on the second day of an unusual three-day meeting called by the FDA after Merck & Co. pulled Vioxx (rofecoxib) from the market in late September. The recall was prompted by a study showing the drug doubled the risk of MI and stroke.
    The FDA, which has come under fire in recent months as being slow to respond to serious side effects of drugs, is asking an advisory panel if COX-2 inhibitors offer enough benefits to stay on the market, if they need stronger warnings, and if further research is needed.
    Graham said he saw a "class effect" of heart risk from the COX-2 inhibitors, and it appeared greater with higher doses. But he told the panel of FDA advisers that each drug should be evaluated individually.
    "The bottom line conclusion I came to is there really doesn't appear to be a need for COX-2 (inhibitors)... I believe there is a cardiovascular effect and it's dose related," Graham told an FDA advisory panel.
    Graham, who is regarded as a maverick for his forthright criticism of the FDA's ability to monitor the safety of drugs once they are on the market, presented preliminary, unpublished findings from his review of records of patients in California covered by the Medicaid health insurance program for the poor.
    The data showed Celebrex (celecoxib) likely increases the chances of heart attacks when taken at higher doses, but Bextra (valdecoxib) does not appear to carry that risk at its approved doses of up to 20 mg. He said the Bextra findings were based on a small amount of data.
    Graham's review linked Celebrex to a "probable increased risk" of heart attacks in higher doses, but "no apparent effect" if patients take 200-mg doses or less. Celebrex is sold at doses of 100 mg, 200 mg and 400 mg.
    Graham's study also showed Vioxx had a "definite" increased risk of heart attacks in patients who took doses higher than 25 mg, but Graham said the risk begins early and is "apparent during days 1-30 of use."Merck had said that the study that led it to withdraw the drug had shown that the risk only occurred after 18 months of continuous use.
    A spokesman for privately held Boehringer Ingelheim Pharmaceuticals, the maker of Mobic, said the company had "taken a look at our post-marketing data and see nothing to indicate excessive cardiovascular risk."Mobic is marketed in the United States by Abbott Laboratorie

    Graham also said the NSAID Mobic (meloxicam), which has become popular since the Vioxx recall, showed an "increased risk" for heart attacks in preliminary data.Merck officials said on Wednesday that the heart risks found with Vioxx were a problem
    for all drugs in the class of COX-2 inhibitors. That clashed with comments by rival Pfizer, which said the heart attack and stroke risks reported with Vioxx appeared "distinct" among the COX-2 class.

    Graham's data was culled from California's Medicaid program, called Medi-Cal, that looked at more than 15,000 heart attack patients. The study is awaiting publication.
    The panel is scheduled to hear later Thursday from Novartis and Merck officials as well as other FDA staff. Another 54 public speakers are also scheduled to speak before the meeting ends on Friday.

    Thursday, February 24, 2005
    Reply   FCK   TinyMCE  
    This is NOT me. This is just randomly assigned avatar, until I upload my own photo. Click here to see my profile.
    • I can't agree with you more   by  #53095     17 y     1,177
      For certain reasons I can't go into details but Merck murdered my father!! So, I feel your pain. Civil cases are one thing but they should pay like any other criminal. So, hopefully the investigations into Merck will continue and justice will be done. I wish peace and comfort to all who have lost a love one due to vioxx.
      Reply   FCK   TinyMCE  
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