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FDA panel to discuss approval of drug which raises safety concerns

March 19, 2009 by  

FDA panel to discuss approval of drug which raises safety concernsDespite serious doubts about its safety, rivaroxaban is still being considered for approval by the FDA.

Rivaroxaban, a once-a-day pill for the prevention of blood clots in hip or knee replacement surgery patients, is also marketed as Xarelto by Bayer AG and Johnson & Johnson.

However, an FDA review has found evidence that the drug causes excessive bleeding and other cardiovascular events at a rate that is twice as high as the existing alternatives, according to a Reuters report.

In addition to the bleeding problem, the agency has also found evidence of an increase in a liver enzyme that may be indicative of liver damage.

The reviewers noted that studies were under way that should provide information regarding liver safety.

Reuters says that the studies are funded by the two drug companies.

FDA’s approval board is expected to make a decision today, after hearing from a panel of outside experts.

The shares of Bayer and Johnson & Johnson’s fell by 10 and 1 percent, respectively, when the documents were released on Tuesday.
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  • http://BACON Rufus Chappell

    NEED TO KNOW ABOUT BAD OR GOOD BACON!

  • http://DiseasesandCancer Rufus Chappell

    Please don’t remove the truth away from me or hide the truth and what causes diseases and cancer from Red meat? I think it comes from only Grill including natural gas or charcoal not from Stove (Electric) or (Natural gas).
    TV news shows the picture of cooking the hamburgers on the Grill which to cause the dieases and cancer. TV news didn’t tell the truth which it caused the diseases and cancer from the GRILL or STOVE.
    THINK Grill is more dieases and cancer than STOVE.
    STOVE is more SAFER!
    I need more articles.
    THANKS

  • http://www.gopetition.com/online/26241.html Marlene B.

    Sign Petition To Stop Television Prescription Drug Ads

    Published by Marlene B. on Mar 18, 2009
    Category: Health
    Region: GLOBAL
    Target: U.S. Congress, FCC, FDA, European Commission, EMEA

    Background (Preamble):
    Statistics prove prescription drugs are 16,400% more deadly than terrorists. According to the Journal of the American Medical Association (JAMA) in 1998, a report finds that prescription drugs kill about 106,000 Americans each year – that’s three times as many as are killed by automobiles—making prescription drug death the fourth leading killer after heart disease, cancer and stroke.

    Last year, the Journal of the American Medical Association puts death from all drugs, illegal and prescription, second only behind car accidents as a cause of death.

    The rise in deaths coincides with the direct marketing of prescription medication to the public. Prescription drug sales have soared nearly 500 percent since 1990.

    The pharmaceutical industry is a multi-trillion dollar business. Companies spend billions on advertising and promotions for prescription drugs. Pharmaceutical companies claim their drug ads are “educational” to the public. The public seems to genuinely believe that drugs advertised on TV are safe, in spite of the plethora of side effects listed. Many of these drugs have proven deadly.

    Every day it’s estimated 2,500 teens abuse a prescription pain killer for the first time.

    The White House Office of National Drug Control policy had been planning to unveil an ad campaign to target prescription drug abuse by teens. It is time to stop this form of advertising by the pharmaceutical companies.
    Petition:
    We, the undersigned, request that Congress, the FDA (Food and Drug Administration), the FCC (Federal Communications Commission), the European Commission, EMEA (European Medicines Agency) stop all television advertising of prescription drugs.
    THE LAST TIME A CURE WAS FOUND FOR A DISEASE
    WAS 1959. DR. JONAS SALK DEVELOPED THE VACCINE
    FOR POLIO. HE WAS JUST ONE MAN.
    SINCE THAT TIME, HUNDREDS OF MILLIONS OF DOLLARS
    HAVE BEEN SPENT ON DISEASE. NOT FOR A CURE, BUT FOR
    DRUG TREATMENT ONLY. A CURE WOULD PUT BIG
    PHARMA OUT OF BIZ. IT SHOULD BE THE JOB OF A PHYSICIAN
    TO PRESCRIBE THE BEST TREATMENTS TO A PATIENT, INSTEAD
    OF PATIENTS ASKING DOCTORS TO PRESCRIBE THESE DRUGS.
    BY ADVERTISING THESE DRUGS, THE PHARMACEUTICAL COMPANIES INVOLVE THEMSELVES IN A LEGAL DRUG TRADE THAT IS KILLING THOUSANDS OF PEOPLE EVERY DAY.

  • http://www.gopetition.com/online/26241.html Marlene B.
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