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Affymax, Inc. Message Board

  • fdatranscripter fdatranscripter Mar 16, 2013 2:04 AM Flag


    Was these results with Fresenius (a German company) really accurate or did their product called Granuflo mis-calculate the results being used in the patient trial data.It could very well be the data retrived was influenced by the concentrate that fresenius uses in dialysis that has a very terrible track record and is the subject of a class action lawsuit involving thousands of patients,as seen by just watching the legel news.This company is in the scope of the FDA and may have their product BANNED use in the United States as many patients have died or had severe medical issues such as heart attacks while using Granuflo in the dialysis clinics.Even as this week the FDA has issued a warning to Fresenius about their dialysis machines and in regards to sterilization issues which subjects their equipment back as far as the year 2000,which could amount to many patients medical issues while recieving dialysis.Granuflo may very well be taken off the market as the FDA will make their decision in due time while other concentrates exist on the market being a safe alternative.

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    • As GranuFlo lawsuits related to Fresenius’ recent recall of GranuFlo and NaturaLyte dialysis concentrates continue to mount, the company is facing more problems with the U.S. Food & Drug Administration (FDA)
      The FDA was already investigating Fresenius for its handling of the GranuFlo recall. That issue, coupled with news of this new FDA warning letter, is certainly concerning.
      GranuFlo and NaturaLyte are used during dialysis to reduce the amount of acid in the blood. According to a New York Times report published over the summer, both have the potential to cause a rapid and unsafe elevation of bicarbonate, which creates a substantially increased risk of cardiopulmonary arrest and death. In November 2011, the company warned its dialysis clinics within its own network about this danger, and advised physicians at those clinics to adjust dosage accordingly. However, a similar warning was not sent to the thousands of independent clinics that had purchased GranuFlo and NaturaLyte from Fresenius.* * It wasn’t until March 2012 that Fresenius issued an “Urgent Product Notification” to its customer clinics with a similar warning, which the FDA would later designate as its most serious recall, Class I.*** According to the Times, the agency also launched an investigation to determine if Fresenius Medical Care’s failure to issue an earlier warning to its customer clinics may have violated the law.

      Since then, dozens of Granuflo recall lawsuits have been filed on behalf of dialysis patients who suffered heart attacks and other catastrophic heart problems within a short time of undergoing dialysis with GranuFlo and NaturaLyte.
      Dialysis patients who suffered heart attacks, sudden cardiac death, and other catastrophic heart side effects within 48 hours of a dialysis treatment with GranuFlo and NaturaLyte

    • fda....I've reviewed all of the data related to O's recall, why didn't Takeda & AFFY simply stop injections for all NEW patients only? The adverse effects only happened to FIRST TIME users, patients already receiving O injections had NO adverse reactions, the drug should still be made available to those patients until the cause is found regarding the FIRST TIME users. Wouldn't that had made more sense instead of ceasing injections for ALL users?

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