The widely used diabetes drug “AVANDIA” should be pulled from the market because of HEALTH risks…

<strong>Diabetes drug should be pulled </strong>.

<a href=’http://babyboomeradvisorclub.wordpress.com/?attachment_id=2306&#8242; rel=’attachment wp-att-2306′ title=’680592236_ea95947074_m.jpg’><img src=’http://babyboomeradvisorclub.files.wordpress.com/2007/07/680592236_ea95947074_m.jpg&#8217; alt=’680592236_ea95947074_m.jpg’ /></a>

<a href=’http://babyboomeradvisorclub.wordpress.com/?attachment_id=2306&#8242; rel=’attachment wp-att-2306′ title=’680592236_ea95947074_m.jpg’><img src=’http://babyboomeradvisorclub.files.wordpress.com/2007/07/680592236_ea95947074_m.jpg&#8217; alt=’680592236_ea95947074_m.jpg’ /></a>

IN FROM WASHINGTON, the widely used diabetes drug <strong>Avandia </strong>should be pulled from the market because of heart risks, a federal scientist said Monday.

Those risks, combined with no unique short-term benefits in helping diabetics control blood-sugar levels, fail to justify keeping Avandia on the market, according to a copy of a slide presentation by Food and Drug Administration scientist Dr. David Graham.

The document was distributed at the onset of a daylong meeting of a joint panel of outside experts convened to consider whether the drug should be restricted to use in select patients and branded with prominent warnings or removed altogether from sale. Previously, the FDA said information from dozens of studies of the GlaxoSmithKline PLC drug points to an increased risk of heart attack.

<strong>Glaxo officials, meanwhile, disputed that claim, citing their own analyses of studies of Avandia, also called rosiglitazone.</strong>

“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,” said Dr. Ronald Krall, the company’s senior vice president and chief medical officer.

The FDA isn’t required to follow the advice of its advisory committees but usually does.

The FDA moved up the date of Monday’s meeting following the May publication of a study by The New England Journal of Medicine that generated new concerns about Avandia’s safety. The pooled analysis of 42 studies revealed a <em>43 percent higher risk of heart attack<strong> for those taking Avandia compared with people taking other diabetes drugs or no diabetes medication.

<a href=’http://babyboomeradvisorclub.wordpress.com/?attachment_id=2307&#8242; rel=’attachment wp-att-2307′ title=’57110336_5ad214c98b_m1.jpg’><img src=’http://babyboomeradvisorclub.files.wordpress.com/2007/07/57110336_5ad214c98b_m1.jpg&#8217; alt=’57110336_5ad214c98b_m1.jpg’ /></a>

Glaxo, meanwhile, says its own data show no increase in heart risks with Avandia compared with other diabetes drugs, including Actos. The FDA’s Graham, in his presentation, said Avandia does increase heart risks — something Actos, from Takeda Pharmaceuticals, does not do.

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.
****************************
Thank you, ANDREW BRIDGES, Associated Press Writer
***********************************************************************
…I rest my case!
~The Baby Boomer Queen~</strong></em>Diabetes drug should be pulled </strong>.

<a href=’http://babyboomeradvisorclub.wordpress.com/?attachment_id=2306&#8242; rel=’attachment wp-att-2306′ title=’680592236_ea95947074_m.jpg’><img src=’http://babyboomeradvisorclub.files.wordpress.com/2007/07/680592236_ea95947074_m.jpg&#8217; alt=’680592236_ea95947074_m.jpg’ /></a>

iN FROM WASHINGTON, the widely used diabetes drug <strong>Avandia </strong>should be pulled from the market because of heart risks, a federal scientist said Monday.
Those risks, combined with no unique short-term benefits in helping diabetics control blood-sugar levels, fail to justify keeping Avandia on the market, according to a copy of a slide presentation by Food and Drug Administration scientist Dr. David Graham.

The document was distributed at the onset of a daylong meeting of a joint panel of outside experts convened to consider whether the drug should be restricted to use in select patients and branded with prominent warnings or removed altogether from sale. Previously, the FDA said information from dozens of studies of the GlaxoSmithKline PLC drug points to an increased risk of heart attack.

<strong>Glaxo officials, meanwhile, disputed that claim, citing their own analyses of studies of Avandia, also called rosiglitazone.</strong>

“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,” said Dr. Ronald Krall, the company’s senior vice president and chief medical officer.

The FDA isn’t required to follow the advice of its advisory committees but usually does.

The FDA moved up the date of Monday’s meeting following the May publication of a study by The New England Journal of Medicine that generated new concerns about Avandia’s safety. The pooled analysis of 42 studies revealed a <em>43 percent higher risk of heart attack<strong> for those taking Avandia compared with people taking other diabetes drugs or no diabetes medication.

<a href=’http://babyboomeradvisorclub.wordpress.com/?attachment_id=2307&#8242; rel=’attachment wp-att-2307′ title=’57110336_5ad214c98b_m1.jpg’><img src=’http://babyboomeradvisorclub.files.wordpress.com/2007/07/57110336_5ad214c98b_m1.jpg&#8217; alt=’57110336_5ad214c98b_m1.jpg’ /></a>

Glaxo, meanwhile, says its own data show no increase in heart risks with Avandia compared with other diabetes drugs, including Actos. The FDA’s Graham, in his presentation, said Avandia does increase heart risks — something Actos, from Takeda Pharmaceuticals, does not do.

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.
****************************
Thank you, ANDREW BRIDGES, Associated Press Writer
***********************************************************************
…I rest my case!
~The Baby Boomer Queen~</strong></em>Diabetes drug should be pulled </strong>.

<a href=’http://babyboomeradvisorclub.wordpress.com/?attachment_id=2306&#8242; rel=’attachment wp-att-2306′ title=’680592236_ea95947074_m.jpg’><img src=’http://babyboomeradvisorclub.files.wordpress.com/2007/07/680592236_ea95947074_m.jpg&#8217; alt=’680592236_ea95947074_m.jpg’ /></a>

iN FROM WASHINGTON, the widely used diabetes drug <strong>Avandia </strong>should be pulled from the market because of heart risks, a federal scientist said Monday.
Those risks, combined with no unique short-term benefits in helping diabetics control blood-sugar levels, fail to justify keeping Avandia on the market, according to a copy of a slide presentation by Food and Drug Administration scientist Dr. David Graham.

The document was distributed at the onset of a daylong meeting of a joint panel of outside experts convened to consider whether the drug should be restricted to use in select patients and branded with prominent warnings or removed altogether from sale. Previously, the FDA said information from dozens of studies of the GlaxoSmithKline PLC drug points to an increased risk of heart attack.

<strong>Glaxo officials, meanwhile, disputed that claim, citing their own analyses of studies of Avandia, also called rosiglitazone.</strong>

“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,” said Dr. Ronald Krall, the company’s senior vice president and chief medical officer.

The FDA isn’t required to follow the advice of its advisory committees but usually does.

The FDA moved up the date of Monday’s meeting following the May publication of a study by The New England Journal of Medicine that generated new concerns about Avandia’s safety. The pooled analysis of 42 studies revealed a <em>43 percent higher risk of heart attack<strong> for those taking Avandia compared with people taking other diabetes drugs or no diabetes medication.

<a href=’http://babyboomeradvisorclub.wordpress.com/?attachment_id=2307&#8242; rel=’attachment wp-att-2307′ title=’57110336_5ad214c98b_m1.jpg’><img src=’http://babyboomeradvisorclub.files.wordpress.com/2007/07/57110336_5ad214c98b_m1.jpg&#8217; alt=’57110336_5ad214c98b_m1.jpg’ /></a>

Glaxo, meanwhile, says its own data show no increase in heart risks with Avandia compared with other diabetes drugs, including Actos. The FDA’s Graham, in his presentation, said Avandia does increase heart risks — something Actos, from Takeda Pharmaceuticals, does not do.

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.
****************************
Thank you, ANDREW BRIDGES, Associated Press Writer
***********************************************************************
…I rest my case!
~The Baby Boomer Queen~</strong></em>, a federal scientist said Monday.
Those risks, combined with no unique short-term benefits in helping diabetics control blood-sugar levels, fail to justify keeping Avandia on the market, according to a copy of a slide presentation by Food and Drug Administration scientist Dr. David Graham.

The document was distributed at the onset of a daylong meeting of a joint panel of outside experts convened to consider whether the drug should be restricted to use in select patients and branded with prominent warnings or removed altogether from sale. Previously, the FDA said information from dozens of studies of the GlaxoSmithKline PLC drug points to an increased risk of heart attack.

<strong>Glaxo officials, meanwhile, disputed that claim, citing their own analyses of studies of Avandia, also called rosiglitazone.</strong>

“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,” said Dr. Ronald Krall, the company’s senior vice president and chief medical officer.

The FDA isn’t required to follow the advice of its advisory committees but usually does.

The FDA moved up the date of Monday’s meeting following the May publication of a study by The New England Journal of Medicine that generated new concerns about Avandia’s safety. The pooled analysis of 42 studies revealed a <em>43 percent higher risk of heart attack<strong> for those taking Avandia compared with people taking other diabetes drugs or no diabetes medication.

<a href=’http://babyboomeradvisorclub.wordpress.com/?attachment_id=2307&#8242; rel=’attachment wp-att-2307′ title=’57110336_5ad214c98b_m1.jpg’><img src=’http://babyboomeradvisorclub.files.wordpress.com/2007/07/57110336_5ad214c98b_m1.jpg&#8217; alt=’57110336_5ad214c98b_m1.jpg’ /></a>

Glaxo, meanwhile, says its own data show no increase in heart risks with Avandia compared with other diabetes drugs, including Actos. The FDA’s Graham, in his presentation, said Avandia does increase heart risks — something Actos, from Takeda Pharmaceuticals, does not do.

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.
****************************
Thank you, ANDREW BRIDGES, Associated Press Writer
***********************************************************************
…I rest my case!
~The Baby Boomer Queen~</strong></em>

~ by thebabyboomerqueen on July 30, 2007.

2 Responses to “The widely used diabetes drug “AVANDIA” should be pulled from the market because of HEALTH risks…”

  1. I took AVANDIA for my Type II diabetis for approximately two months. I had to discontinue its use when I still had a full bottle… too many side effects were killing me, including water retention (my ankles were swollen, etc.). It is a dangerous drug that should not be used.

    I have since been taking another drug that begins with a J (Junavia, Januvia, or something like that) that was authorized by the FDA in October 2006 and so far it has been God sent. My diabetis is totally under control, I do not feel any side effects, wake up in the morning without headaches, etc. and my feet are back to normal in size.

    Ask your doctor about the new Januvia which work in a totally different way from the old prescriptions and has so swelling or side effects.

  2. Okay, we all know who he is, we all know his stance on Seroxat ‘I think patients have nothing to fear taking Seroxat’ but did you know he is now defending the diabetes drug, Avandia?

    Read more here:

    http://fiddaman.blogspot.com/2007/08/is-alistair-benbow-deranged.html

    Fid

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