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Harsher Warnings for NSAIDS
Last review: 08/12/10
The FDA sent proposed label changes to various painkiller manufacturers regarding the risks associated with their drugs. According to the FDA's Web site, the new warnings were delivered to all makers of NSAIDS -- both prescription and over-the-counter.

Some of the suggested alterations include:

  • Celebrex and other prescription NSAIDs must include a black box warning about the potential risk of gastrointestinal bleeding and increased heart disease, as well as a description of a rare skin condition, Stevens-Johnson Syndrome, triggered by painkiller use.

  • "NSAID" must be prominently displayed and distinguishable in color or type from the rest of the copy of the label.

  • Labels on over-the-counter NSAIDs containing ingredients such as generic ibuprofen, ketoprofen and naproxen must include information regarding allergic reactions, as well as internal bleeding and heart problems.

    USA Today June 16, 2005


    Dr. Mercola's Comment:
    An interesting pattern; many of you may have already noticed it.

    A new drug is released and, over time, more and more warning labels are mandated by the FDA to be included as cautions to the public and physicians. However, since most of us are too busy to pay attention to these warnings, few heed them.

    As a result, more and more people die or are seriously injured from taking the drugs. Once enough people are killed from the drug, it is finally pulled off the market.

    Now, of course, this doesn't happen with every drug, but it has happened frequently enough to be concerned. You just don't have any level of assurance that the drug you are using might fall into this category.

    Many people use this newsletter as a resource to screen their drug and see if there are any imminent concerns that the drug they are using is ready to kill them.

    With respect to NSAIDs, if you're still using these potentially toxic drugs to relieve your pain, I urge you to read an article I wrote earlier this year that featured a comprehensive list of safer, more natural alternatives to NSAIDS. You can even share them with your own doctor, who hopefully understands the value of natural medicine and can help determine the most effective combination for you.

    Also remember that Tylenol has its own problems and can cause serious harm.

    If you are taking any other drug, though, please use the newsletter search engine to see if there aren't already obvious concerns that the FDA has failed to respond to yet.

    Please remember that I was the very first person to warn of the Vioxx debacle. It was posted on this site one year before the drug was released. If you had used the search engine, you would have known not to take it.

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