Yesterday I brought you an article about a new experimental drug from GlaxoSmithKline called Promacta. Its purpose is to lower bleeding in patients with rare blood disorders but the U.S. Food and Drug Administration released a report stating that the agency had found that the drug did not, yes i repeat, NOT, significantly lower bleeding.
The next step was to submit all data to a panel of outside advisors who would vote on whether they had found that the drug fell within acceptable parameters.
Today it was announced, by the FDA, that the panel voted unanimously in favor of Promacta. It was noted, however, that long-term data has not been provided but that results from two six-week studies showed significant benefit. Long term benefit data is expected by year end. The FDA has until June 19 to make a final decision regarding the drugs approval and is not required to follow the outside panel's advice though normally it does.
Makes you wonder if the outside panel read the same report as that FDA reviewers who found no difference when compared to a placebo in the two studies that were submitted for review. The FDA also voiced concerns about liver toxicity and long term safety and efficacy.
[Source: Yahoo News]
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There is a product on the market named KytoStat that helps individuals with bleeding disorders. The product has received FDA approval. KytoStat is as easy to use as a regular bandaid. Just apply it to the wound and it stops the bleeding. You don’t even need to wipe the blood away. In fact, the blood allows the chitosan in KytoStat to seal the wound. This bandage could save your life! For more information, visit http://www.kytostat.com.
Posted by: ely perez | June 2, 2008 12:00 PM | Permalink to Comment