Avandia |

February 20, 2010 by Post Team 

heart-attackAvandia | is the reason causing hundreds of cases of heart attacks and heart failure of each month, according to the reports of secret government, The New York Times writes. Moreover, if taken Avandia diabetes were given Actos Instead, about 500 heart attacks and 300 cases of heart failure can be avoided in every month. Pill linked to 304 deaths during the third quarter of 2009, a report by the Food and Drug Administration, David Graham and Kate Gelperin get rid of the pill must be grabbed (Graham said this in 2007 – a look).

Some officials at the Food and Drug Avandia wanted to withdraw because they believe a safer alternative exists, adds the newspaper, referring to others insist on the provision of studies and contradictory information Avandia should remain an option. GlaxoSmithKline, which makes the pill, and says it is considering large-scale and Avandia, “the scientific evidence simply does not demonstrate that Avandia increases” the risk of a heart attack. Debate, which began with the definition andanlysis in the New England Journal of Medicine (see here and here) is to intensify due to the difference on the new clinical trial and an inquiry in the Senate, concluding Glaxo should be warned of the risks earlier.

In December 2009 internal memorandum, the official Janet Woodcck, and wrote “there are several conflicting views” on Avandia within the agency (see here), and ordered an advisory committee is expected to meet this summer to re-examine whether the drug should be sold. FDA commish Margaret Hamburg, the paper says it will await the recommendations of the Committee, but is reviewing the results of the Senate, which is expected to be released on Monday. Investigation criticized GlaxoSmithKline for failing to warn patients years Avandia, which could be lethal.

“Instead, GlaxoSmithKline executives attempt to intimidate independent physicians (see here), which focuses on strategies to reduce or distort the results that Avandia may increase the risk of heart and blood vessels, and discuss ways to minimize the importance of the results of the competing drugs may reduce the risk cardiovascular diseases, “according to the report by Max Baucus, a Montana Democrat, and Chuck Grassley, a Republican from Iowa, which won the New York Times.

Graham said Gelperin and argued in a new, separate internal reports Glaxo study called for the tide “unethical and exploitative” Because Avandia patients who face a higher risk than those given Actos, with the promise of any additional benefit. The trial and could include patients who had heart attacks or chest pain in spite of the organizers warned against foreign drug Avandia for use by such patients. “The safety study itself can not be guaranteed and unacceptable”, one finds the report.

Internal reports, which were dated October 2008 and has yet to announce, at the time was later rejected by FDA officials and other drugs, Glaxo is currently registered patients in the trial of the tides, which are not expected to be completed until 2020, despite the fact that The company, hoping to report some results of the Food and Drug Administration by the year 2014. But by 2012, notes the Times, Avandia and patents expire.

Grassley said in an internal battle, shows the agency the FDA needs to be reorganized to give more authority to the officials of the safety of their peers who approve drugs and to deal more directly with industry. “We do not make any sense that these experts who study drugs after they have been on the market for several years under the tutelage of the officials who approved the drug in the first place and have a natural interest in defense of this resolution,” Grassley tells the Times. “The issue Avandia, for example, may be more of a concern than the problem with this setup.”

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