Public Health Advisory: FDA Recommendations Concern ing the Use of NSAIDs

  1. 0
    MedWatch - The FDA Safety Information and Adverse Event Reporting Program

    The FDA issued a Public Health Advisory summarizing the agency's recent
    recommendations concerning the use of non-steroidal anti-inflammatory drug
    products (NSAIDs), including those known as COX-2 selective agents. This
    advisory was issued because of recently released data from controlled
    clinical trials showing that the COX-2 selective agents (Vioxx, Celebrex,
    and Bextra) may be associated with an increased risk of serious
    cardiovascular events (heart attack and stroke) and after release of
    preliminary results from a long-term clinical trial which suggested that
    long-term use of a non-selective NSAID, naproxen (sold as Aleve, Naprosyn
    and other trade name and generic products), may be associated with an
    increased cardiovascular risk compared to placebo. The public health
    advisory is an interim measure, pending further review by FDA of data that
    continue to be collected.

    Read the MedWatch 2004 safety summary, including links to the PHA and FDA
    Talk Paper, at:

    http://www.fda.gov/medwatch/SAFETY/2...y04.htm#nsaids
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  4. 1 Comments so far...

  5. 0
    Thanks Brian -

    I had my own bad experience with Celebrex. I stared having problems breathing and had the "impending sense of doom". It was very frightening. I called a friend who lived close by. She came and stayed with me until I started feeling better. I never took the drug again. That was years ago.

    I hope that nurses who use Bextra at work talk this issue up with doctors to see if there is a different drug that can be used. It's not worth it to wait and see if something bad happens. We should all pay attention to these kind of warnings and try to move to different drugs that are safe and get the job done.



    Thanks
    Quote from brian
    MedWatch - The FDA Safety Information and Adverse Event Reporting Program

    The FDA issued a Public Health Advisory summarizing the agency's recent
    recommendations concerning the use of non-steroidal anti-inflammatory drug
    products (NSAIDs), including those known as COX-2 selective agents. This
    advisory was issued because of recently released data from controlled
    clinical trials showing that the COX-2 selective agents (Vioxx, Celebrex,
    and Bextra) may be associated with an increased risk of serious
    cardiovascular events (heart attack and stroke) and after release of
    preliminary results from a long-term clinical trial which suggested that
    long-term use of a non-selective NSAID, naproxen (sold as Aleve, Naprosyn
    and other trade name and generic products), may be associated with an
    increased cardiovascular risk compared to placebo. The public health
    advisory is an interim measure, pending further review by FDA of data that
    continue to be collected.

    Read the MedWatch 2004 safety summary, including links to the PHA and FDA
    Talk Paper, at:

    http://www.fda.gov/medwatch/SAFETY/2...y04.htm#nsaids


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