Ask me what a Blotnik is. This Blog is my Public Blog. Sometimes in Hebrew. I have found that Books and the Internet have something in common, Life is to Short to read all the books you would like to read, (not those that you do not want). Also 24 Hours a day is not Enough for all you would like to do on the Internet!
Friday, May 25, 2007
Tuesday, May 22, 2007
Widely used diabetes pill Avandia might significantly increase the risk of heart attacks.
Study raises questions about Glaxo diabetes drug
By Stephanie Saul
Tuesday, May 22, 2007
NEW YORK: Clinical trials show that the widely used diabetes pill Avandia might significantly increase the risk of heart attacks, according to an article being published in The New England Journal of Medicine.
The U.S. Food and Drug Administration issued what it called a "safety alert" in response, advising patients who are taking Avandia, particularly those at high risk for a heart attack, to seek advice from their doctors.
The agency also said it had been evaluating a possible risk increase since August and announced plans to convene an advisory panel to review the issue as quickly as possible. But government regulators cautioned that they had not confirmed the significance of the findings.
The New England Journal of Medicine posted the paper Monday on its Web site, ahead of its print publication June 14, a step that the editors take with matters they consider to have implications for public health.
"We view this as the best publicly available data on a very important question," said the editor of the journal, Dr. Jeffrey Drazen. "It shows what we regard as a preliminary, but worrisome, signal about cardiovascular toxicity of this drug."
While noting possible weaknesses in data used in the analysis, an accompanying editorial calls for a review by the U.S. Food and Drug Administration. It also questions why physicians would prescribe Avandia, which is made by the British pharmaceutical company GlaxoSmithKline and is known generically as rosiglitazone.
In a statement, Glaxo said it strongly disagreed with the conclusions of the report, Reuters reported.
"GSK stands firmly behind the safety of Avandia when used appropriately, and we believe its significant benefits continue to outweigh any treatment risks," the company said.
Avandia, on the market since 1999, is used by an estimated two million people a year worldwide for the treatment of Type 2, or adult-onset, diabetes. With $3.2 billion in worldwide sales last year, it was Glaxo's second-biggest product, after the asthma drug Advair.
Drazen said patients concerned about the drug should meet with their doctors to decide whether to remain on it or switch to another drug.
The finding - that Avandia raises the risk of heart attack by 43 percent - was based on a review of 44 studies of the drug. The review was conducted by Dr. Steven Nissen and Kathy Wolski of the Cleveland Clinic, where Nissen is chief of cardiovascular medicine.
Nissen was among the first doctors to raise questions about the cardiovascular safety of Vioxx, the Merck painkiller that was withdrawn from the market in 2004.
Nissen's letter noted increased cardiovascular problems in a 5,000-patient clinical study. GlaxoSmithKline sponsored the trial in an effort to expand use of Avandia beyond a treatment of diabetes to a prevention of it.
In the trial, patients taking Avandia had 66 percent more heart attacks, 39 percent more strokes and 20 percent more deaths from cardiovascular-related problems.
The New York Times
Copyright © 2007 The International Herald Tribune | www.iht.com
By Stephanie Saul
Tuesday, May 22, 2007
NEW YORK: Clinical trials show that the widely used diabetes pill Avandia might significantly increase the risk of heart attacks, according to an article being published in The New England Journal of Medicine.
The U.S. Food and Drug Administration issued what it called a "safety alert" in response, advising patients who are taking Avandia, particularly those at high risk for a heart attack, to seek advice from their doctors.
The agency also said it had been evaluating a possible risk increase since August and announced plans to convene an advisory panel to review the issue as quickly as possible. But government regulators cautioned that they had not confirmed the significance of the findings.
The New England Journal of Medicine posted the paper Monday on its Web site, ahead of its print publication June 14, a step that the editors take with matters they consider to have implications for public health.
"We view this as the best publicly available data on a very important question," said the editor of the journal, Dr. Jeffrey Drazen. "It shows what we regard as a preliminary, but worrisome, signal about cardiovascular toxicity of this drug."
While noting possible weaknesses in data used in the analysis, an accompanying editorial calls for a review by the U.S. Food and Drug Administration. It also questions why physicians would prescribe Avandia, which is made by the British pharmaceutical company GlaxoSmithKline and is known generically as rosiglitazone.
In a statement, Glaxo said it strongly disagreed with the conclusions of the report, Reuters reported.
"GSK stands firmly behind the safety of Avandia when used appropriately, and we believe its significant benefits continue to outweigh any treatment risks," the company said.
Avandia, on the market since 1999, is used by an estimated two million people a year worldwide for the treatment of Type 2, or adult-onset, diabetes. With $3.2 billion in worldwide sales last year, it was Glaxo's second-biggest product, after the asthma drug Advair.
Drazen said patients concerned about the drug should meet with their doctors to decide whether to remain on it or switch to another drug.
The finding - that Avandia raises the risk of heart attack by 43 percent - was based on a review of 44 studies of the drug. The review was conducted by Dr. Steven Nissen and Kathy Wolski of the Cleveland Clinic, where Nissen is chief of cardiovascular medicine.
Nissen was among the first doctors to raise questions about the cardiovascular safety of Vioxx, the Merck painkiller that was withdrawn from the market in 2004.
Nissen's letter noted increased cardiovascular problems in a 5,000-patient clinical study. GlaxoSmithKline sponsored the trial in an effort to expand use of Avandia beyond a treatment of diabetes to a prevention of it.
In the trial, patients taking Avandia had 66 percent more heart attacks, 39 percent more strokes and 20 percent more deaths from cardiovascular-related problems.
The New York Times
Copyright © 2007 The International Herald Tribune | www.iht.com
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