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I'd like to hear more clarification from the FDA and Merck on t...

Posted at 9:47 PM on Jan 16, 2009 by matthewct1, #38094
I'd like to hear more clarification from the FDA and Merck on the following media statements: "Merck believes that the data support the continued use of Singulair in appropriate patients with asthma and allergic rhinitis.” But, the agency also noted that the trials were not designed to examine such behavior, and that the safety review will continue, probably for several more months." If the trials were not designed to examine psychiatric events what good is the data and why would it take 9 months to rehash submitted data that does not contain appropriate information? Another statement that needs clarification is, "Merck believes that the data support the continued use of Singulair in appropriate patients with asthma and allergic rhinitis.” Why such careful wording as "appropriate patients"? That is to suggest that Singulair is "inappropriate" for some, perhaps many people. Lastly, "We have finished our analyses of all the data the companies submitted," FDA spokeswoman Karen Riley told the Associated Press. "But that doesn't mean we have closed the book on suicidality." My questions are were there any unsubmitted data and why would they leave the book open unless there were a legitimate reason to? This is definitely not over and as well it should not be.
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Reply 10 months ago on Jan 17, 2009 by pumkin1, #16104

Mat you asked;

Why would it take 9 months for FSA to rehash submitted data that does not contain appropriate information?

My opinion FDA is using time and stall tacktics not to do analysis of what went wrong but to studies & do analysis to find ways of how to cover up their mistakes.

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Reply 10 months ago on Jan 17, 2009 by ms76, #16110

Maybe they realized that it was a big mistake to approve this drug without requiring more studies first.

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