WASHINGTON (AP) -- Government health advisers overwhelmingly recommended Monday that the widely used diabetes drug Avandia should remain on the market, saying evidence of an increased risk of heart attack doesn't merit removal. Although nonbinding, it is a recommendation by a panel to the Food and Drug Administration .
One of the panel's patient representative stated "We're being asked today to take a very draconian action based on studies that have very significant weaknesses and are inadequate for us to make that kind of decision." This is a diferent view by an earlier 20-3 vote by the panelists which said that available data showed the drug does increase heart risks.
The company's senior vice president and chief medical officer stated "The number of myocardial infarctions is small, the data are inconsistent and there is no overall evidence rosiglitazone is different from any other oral antidiabetes agents." Previously, the FDA had said information from dozens of studies pointed to an increased risk of heart attack.
About 1 million Americans with Type 2 diabetes use Avandia to control blood sugar by increasing the body's sensitivity to insulin. That sort of treatment has long been presumed to lessen the heart risks already associated with the disease, which is linked to obesity. News that Avandia might actually increase those risks would represent a "serious limitation" of the drug's benefit, according to the FDA.
The FDA moved up the date of Monday's meeting after the May publication of a study in The New England Journal of Medicine that generated new concerns about Avandia's safety. The analysis of 42 studies revealed a 43 percent higher risk of heart attack for those taking Avandia compared with people taking other diabetes drugs or no diabetes medication.Separately, the FDA is working to add so-called "black box" warnings to the labels of both Avandia and a second oral diabetes drug, Actos, to caution patients about the increased risk of heart failure associated with the drugs. That risk is separate from those discussed Monday.
The diabetes epidemic affects more than 18 million Americans. Most have Type 2, where the body makes too little insulin or cannot use what it does produce.Each day, there are 4,100 new cases of diabetes in the United States, and 810 deaths, said Dr. Robert Ratner, vice president of medical affairs at the MedStar Research Institute. Of those deaths, 60 percent are due to heart disease, Ratner told the panel.Congress has pointed to Avandia as evidence of FDA's fumbling of safety problems that emerge long after drugs win agency approval. The House and Senate are at work on legislation to overhaul the FDA.
One of the panel's patient representative stated "We're being asked today to take a very draconian action based on studies that have very significant weaknesses and are inadequate for us to make that kind of decision." This is a diferent view by an earlier 20-3 vote by the panelists which said that available data showed the drug does increase heart risks.
The company's senior vice president and chief medical officer stated "The number of myocardial infarctions is small, the data are inconsistent and there is no overall evidence rosiglitazone is different from any other oral antidiabetes agents." Previously, the FDA had said information from dozens of studies pointed to an increased risk of heart attack.
About 1 million Americans with Type 2 diabetes use Avandia to control blood sugar by increasing the body's sensitivity to insulin. That sort of treatment has long been presumed to lessen the heart risks already associated with the disease, which is linked to obesity. News that Avandia might actually increase those risks would represent a "serious limitation" of the drug's benefit, according to the FDA.
The FDA moved up the date of Monday's meeting after the May publication of a study in The New England Journal of Medicine that generated new concerns about Avandia's safety. The analysis of 42 studies revealed a 43 percent higher risk of heart attack for those taking Avandia compared with people taking other diabetes drugs or no diabetes medication.Separately, the FDA is working to add so-called "black box" warnings to the labels of both Avandia and a second oral diabetes drug, Actos, to caution patients about the increased risk of heart failure associated with the drugs. That risk is separate from those discussed Monday.
The diabetes epidemic affects more than 18 million Americans. Most have Type 2, where the body makes too little insulin or cannot use what it does produce.Each day, there are 4,100 new cases of diabetes in the United States, and 810 deaths, said Dr. Robert Ratner, vice president of medical affairs at the MedStar Research Institute. Of those deaths, 60 percent are due to heart disease, Ratner told the panel.Congress has pointed to Avandia as evidence of FDA's fumbling of safety problems that emerge long after drugs win agency approval. The House and Senate are at work on legislation to overhaul the FDA.
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