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    FDA fails to approve cholesterol drug for kidney disease

    WASHINGTON (Reuters) - U.S. health regulators amended the prescribing label for Merck & Co's cholesterol-lowering drug Vytorin to show it prevents heart problems in patients with chronic kidney disease, but stopped short of approving its use for that purpose.

    The decision means Merck cannot market Vytorin as a treatment for reducing the rate of heart problems in kidney patients, though it can discuss the new label with doctors.

    Merck had asked the Food and Drug Administration to approve the new indication, and the company relayed the agency's decision on Wednesday.

    "The final outcome is slightly disappointing, as many street observers had expected an actual new indication claim," Mark Schoenebaum, an analyst at ISI Group, said in a report.

    Vytorin pairs a new type of cholesterol fighter Zetia, or ezetimibe, with Merck's older statin drug Zocor, or simvastatin.

    Vytorin is already approved for lowering cholesterol, but the company had been hoping to expand its use to prevent stroke and other heart problems in patients with chronic kidney disease.

    Chronic kidney disease affects about 14 percent of the U.S. population and puts people at a high risk of developing heart disease and having a stroke or heart attack.

    The new labeling reflects the findings of the SHARP study, which showed Vytorin reduced the risk of major vascular problems in patients with moderate to severe chronic kidney disease.

    It was the first randomized controlled study that showed statins can lower the rate of heart problems in kidney disease patients, Merck said.

    However, because the study did not look at the individual contributions of Zetia and Zocor to the reduction in heart problems, the FDA did not approve a new indication for Vytorin or Zetia, Merck said.

    Merck's patents on both Vytorin and Zetia expire in 2017. In 2010, Vytorin posted sales of $2 billion and Zetia reaped $2.3 billion.

     

    7 comments

    • Ginger  •  Santa Paula, California  •  27 days ago
      I took Liptor for 1 year and Vytorin for 2 years they caused muscle pain, cramps,spasms, slurred speech memory loss and possible nerve damage for me. Hopefully they won't allow these drugs to be given to children like they want. Maybe this time the FDA will look out for the citizens and not those other guys that we all know who they are.
    • Shirley M  •  27 days ago
      Still trying to push that statin for every health problem , but over 70 percent of the people are on the stuff for somereason and for no reason except the drug company wants more money
      I myself can not use it because my muscles hurt so bad I could not sleep at night
    • LINDE  •  Greenville, South Carolina  •  27 days ago
      I have a renal (kidney) condition named 'Rhabdomyolysis'- Rhab for short.
      As I was searching the internet for info on Rhab I visited a few help sites.
      One thing most people had in common were statin drugs used to lower cholesterol.
      Statins may actually cause Rhab in individuals.
      I was never prescribed a statin drug as I've never had a problem with high cholesterol.
      Rhab can be fatal if not treated as it causes the kidney's to not function by not filtering out the toxins in urine and blood. My Creatinine (a toxin) level was a horrific 669 mg/dL where normal levels are within the 0.60 - 1.10 mg/dL range. I could have died.
      ER room physicians wanted to keep me overnight to run bags of IV fluids through my system to help my kidneys filter the toxins out. I have no insurance so they suggested that if I could drink a gallon of water a day this would also have the desired effect. That's what I did and what I still do.
      I just had all my labs checked last week and my creatinine level was 0.71 and the reference range is between 0.60 - 1.10 mg/dL.
      Rhab is dangerous with many not realizing that they have it. There are other ways of getting Rhab I would recommend using your search engine of choice to better understand about Rhab. I know what I am trying to say but the internet is far better at explaning this than I am.
      Thanks for listening!
    • Starr  •  Arden, North Carolina  •  27 days ago
      I dislike the headline - how about instead of "FDA Fails to Approve" - which makes it sound like the agency did something wrong, it should say "Drug Fails to Achieve FDA Approval" which shows the agency protects people from incorrect drug company claims.
    • ENDO-  •  26 days ago
      "FDA fails".. how is this even news?
    • Dale A Wood  •  Huntsville, Alabama  •  27 days ago
      Yes, those people who write headlines for articles are very often dummies who seem to have very little education. They just write down the first thing that pops into their minds, rather than paying any attention to the true implications of what they wrote -- and then correcting their prose. It happens all the time. D.A.W.

      Re: I dislike the headline - how about instead of "FDA Fails to Approve" - which makes it sound like the agency did something wrong, it should say "Drug Fails to Achieve FDA Approval" which shows [that] the agency protects people from incorrect claims by drug companies.
    • Bendover American  •  26 days ago
      For ALL the drugs and poor quality foods our great FDA has approved does one more really matter all that much. Cigarettes so harmful that they can’t advertise yet some of these drug commercials which last for an entire minute spend 40 seconds talking about the hazards of their products we could just as well have cigarette commercials with the same disclaimers. Surely the FDA is holding out for bigger bribe because we’ve never been their chief concern. Having an agent on staff at a poultry farm inspecting not the quality and health issues of the chickens laying the eggs, but ignoring public safety to measure the size of the eggs, what freaken joke government agencies have become. Wanna cut the budget, lets cut a bunch of these irresponsible agencies because they serve themselves not the health and well-being of our citizenry
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