Avandia: Is it time to pull it off the market?

UPDATE: 15 July - FDA reviewer David Graham told the panel Avandia's risks were real enough "to put you in a hospital or a cemetery."

Graham, who wants the pill banned, recently published an analysis estimating that as many as 100,000 heart-related problems may have been caused by Avandia among seniors on Medicare.
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I remember back in 2004 coming across a report on the cardiovascular risk from Avandia. It caught my eye because I knew someone taking the drug and I took the opportunity to advise him of the issue.

Over the almost seven years since I first had reports of problems, it seems as if the controversy hasn't stopped.

Since the problems in the US were reported recently, Avandia now seems to be having problems in Europe.

Diabetes Drug Maker Hid Test Data on Risks, Files Indicate - Dates to 1999

By Emily P. Walker, Washington Correspondent, MedPage Today Published: July 11, 2010

WASHINGTON -- FDA staff reviewers blasted rosiglitazone (Avandia) in briefing documents released Friday, recommending that the diabetes drug be yanked from the market because of the "serious" cardiovascular risks it poses.
Rosiglitazone is no more effective at improving glycemic control in type 2 diabetes than pioglitazone (Actos) and provides no known unique health benefits, FDA reviewers wrote. While both drugs increase the risk of congestive heart failure, the effects of rosiglitazone are "substantially greater," the briefing documents concluded.
It remains to be seen whether a joint panel of outside medical experts will agree with this assessment. The panel meets July 13 and 14 to make recommendations about rosiglitazone -- including whether to pull the drug from the market.
Next week's meeting will be the second time an advisory panel has been asked to guide the FDA on what to do about rosiglitazone.
In 2007, a panel voted 20 to 3 that rosiglitazone increased cardiovascular risks, but then decided 22 to 1 that the benefits outweighed the risks.
In their current review, the FDA faulted the logic of the 2007 advisory decision, saying the panel failed to document the specific benefits of rosiglitazone. Since then, the benefits of the drug remain unclear, the agency said.
Next week's panel will review a number of different studies, including a post-marketing study the FDA reviewers branded as unethical.
A spokeswoman for GlaxoSmithKline said the company stands behind the safety and efficacy of rosiglitazone.

To me this falls into that category of covering up the facts as we have seen with so many other drugs throughout the last decade. And its an adjunct to this smirky comment about looking at the health protection agencies of the planet; they put forth propaganda with the purpose of causing fear....and to sell drugs.

The focus too long has been the profit motive and not public health!

GlaxoSmithKline's Diabetes Drug Avandia Draws More Scrutiny in Europe
By MELLY ALAZRAKI, Daily Finance, 07/09/10

Problems for GlaxoSmithKline's (GSK) diabetes drug Avandia seem to be getting worse. The European Medicines Agency said Friday it's launching a new review of Avandia's benefit-risk profile following new data on the possibility of cardiovascular problems.

Avandia has been in the crosshairs of scientists, regulatory agencies and even U.S. senators in the past year. The EMA decision only adds to the already existing pressure. GSK shares tumbled 2.5% in premarket trading.

Last month, two new studies linked rosiglitazone, or Avandia, to heart attacks and other cardiovascular complications. The authors of the studies said the results should prompt regulators to pull the drug from the market. A U.S. Food and Drug Administration panel is indeed going to study the data next week.

A New Reevaluation

Now, the EMA will also be considering Avandia following the recent studies. Already, the product has been reviewed several times by the agency's Committee for Medicinal Products for Human Use, which has updated the product information to include warnings on the use of these medicines in patients with heart problems. In 2008, the committee concluded that "rosiglitazone retained a small, if diminishing, place in diabetes type 2 therapy." Then again, it looked at the drug earlier this year.

The committee is now assessing the new data and will be discussing the issue at its next plenary meeting, July 19-22.

"Once all relevant data on the benefits and the risks of rosiglitazone have been looked at, the CHMP will issue an opinion on whether or not the marketing authorisations for these medicines should be revoked, suspended or changed," the EMA said in a statement.

The EU has authorized rosiglitazone on its own is as Avandia, in combination with metformin as Avandamet, and with glimepiride as Avaglim.

"Insufficient Data"?

GSK has defended Avandia, saying two heart associations have found that "Insufficient data exist to support the choice of" one treatment over the other. Still, sales of Avandia, which topped $2.6 billion in 2006, fell to $1.2 billion in 2009 after the FDA added a label warning regarding the elevated cardiac risk.

Judging from investors' reaction, the pressure on this drug is likely to keep mounting.
http://www.dailyfinance.com/story/investing/glaxosmithkline-avandia-europe/19547971/#

from Natural Health News - 4 of 14 articles referring to Avandia
FDA and Avandia: Ethics Lacking
Jun 05, 2010
FDA-Sanctioned International Diabetes Drug Trial Is Unethical and Dangerous “Surely no patient would willingly participate in a trial in which they have a substantial likelihood of taking a drug that, in the opinion of a large group of ...

Risks Potentially Outweigh Benefits with Avandia®
Jan 14, 2009
Avandia®, manufactured by GlaxoSmithKline (GSK), was first approved by the FDA in 1999 for marketing on the basis of its ability to lower blood glucose and reduce insulin resistance. By 2006 the drug had become the top selling oral ...

Avandia Increases Bone Risk for Women
Dec 10, 2008
GlaxoSmithKline, which markets rosiglitazone as Avandia, said the safety and effectiveness of the drug was backed by one of the largest clinical trial programmes ever undertaken for any medicine, with 52000 patients studied. ...

Here is another well thought out idea
Sep 15, 2006
Now for women you'll get more drug because Avandia is not as effective for you. However if you already have liver or kidney dis-ease you should not take this drug! And it will increase your LDL level so - hey - more drugs. ...

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Posted in: Avandia,diabetes,diabetes drugs health risk,GlaxoSmithKline

FDA and Avandia: Ethics Lacking

FDA-Sanctioned International Diabetes Drug Trial Is Unethical and Dangerous
“Surely no patient would willingly participate in a trial in which they have a substantial likelihood of taking a drug that, in the opinion of a large group of experts, has no role in present day therapeutics because of its risks,” Wolfe said. “The trial shouldn’t continue because the question has been answered. If the trial continues, the health of thousands of patients will be jeopardized. It is unethical to continue this trial. As unethical as it is in developed countries such as the U.S. and Canada, it is even more unconscionable to subject people in developing countries such as Chile, Mexico, Colombia, Latvia, Pakistan and India to a drug known to be more dangerous than the drugs it is being compared to.” 
Complete areticle

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Posted in: Avandia,ethics,FDA

Even More Evidence Links Glitazones to Broken Bones

Along with the FDA warnings on asthma drugs we now get more data that glitazones are a hazard to bone health.

Perhaps this is another issue to be raised in the insurance debacle, cut payments to Big Pharma for dangerous drugs allowed on the market before real effects of the drugs are fully discovered.

See also: http://naturalhealthnews.blogspot.com/2008/12/avandia-increases-bone-risk-for-women.html
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15 June
ADA 2009: More Evidence Links Glitazones to Broken Bones
Shelley Wood

June 12, 2009 (New Orleans, Louisiana) - The largest study to date looking at whether the risk of bone fractures is increased in the setting of thiazolidinedione drugs (TZDs) suggests that fracture risk is more than 40% higher in people taking TZDs and that both men and women are vulnerable [1].

The analysis, presented by Dr Merri Pendergrass (Harvard University, Boston, MA) and colleagues during the American Diabetes Association (ADA) 2009 Scientific Sessions, looked at almost 70 000 patients taking either rosiglitazone (Avandia, GlaxoSmithKline) or pioglitazone (Actos, Takeda) and, unlike other studies, found no difference in fracture risk between the two TZDs.

"I think these agents should be avoided in people at high risk for fracture--unless, of course, particular benefits for a particular patient seem high," Pendergrass told heartwire --for example, a patient with high hypoglycemia risk who is not a good candidate for other classes of medications. Of note, Pendergrass continued, diabetes itself increases the risk for fracture. "So a postmenopausal woman with diabetes would have a particularly high risk--especially if she smoked, had a family history of fracture, or other additional fracture risk factors."

Pendergrass and colleagues reviewed the Medco database--more than 13 million people--looking for all patients between the ages of 43 and 63 at study onset with diabetes and a TZD prescription or any diabetic patients within the same age group taking metformin, exenatide (Byetta, Amylin/Lilly), or a sulfonylurea. They then used a linear-regression model to adjust for age, chronic obstructive pulmonary disease (COPD), asthma, osteoporosis, stroke, and prior fracture to compare fracture risks in patients with "glitazone" prescriptions and in patients with no TZD prescription over the study period (January 2006 through June 2008).

They found that fracture rates were higher among all patients taking TZDs, with no difference between those taking pioglitazone vs rosiglitazone. Fracture rate was also higher in both women taking TZDs vs controls and in men taking TZDs vs controls (although the fracture rate was higher in women than men). According to Pendergrass, this is the first study to show an increased fracture rate in men as well as women. Of note, however, an analysis that looked only at recent TZD prescriptions did not find an increased fracture risk in men, suggesting that men may need to be on the drugs for longer than 18 months before developing an increased risk of broken bones.

Both older women and older men (age 50 to 65 at study conclusion) had a significantly increased fracture risk, but in younger subjects (age 43 to 49) only women were at significantly increased risk. Of note, the study could not control for alcohol consumption and smoking, both of which are known risk factors for fractures. Older adults (age 65 and older) could not be included in the analysis, due to a lack of data, the authors note.

Odds Ratios for Fracture Risk Group Odds ratio 95% CI
All patients 1.43 1.35–1.50
All women 1.55 1.44–1.65
All men 1.26 1.16–1.38
New TZD Rx, women* 1.40 1.19–1.64
New TZD Rx, men* 1.09 0.88–1.35
Rosiglitazone vs pioglitazone 1.03 0.96–1.11
*<18 mo

Pendergrass has previously disclosed research grant support from Novo-Nordisk.

References
Aubert RE, Herrera V, Tully L, et al. Thiazolidinedione treatment increases the risk of fracture. American Diabetes Association 2009 Scientific Sessions; June 7, 2009; New Orleans, LA. 601-P. Authors and Disclosures
Shelley Wood is a journalist for theheart.org, part of the WebMD Professional Network. She has been with theheart.org since 2000, and specializes in interventional cardiology. She studied literature at McGill University and the University of Cape Town and received her graduate degree in journalism from the University of British Columbia, specializing in health reporting. She can be reached at SMWood@webmd.net.
Heartwire © 2009 Medscape, LLC

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Posted in: Avandia,bone health,dangerous drugs,natural health news

Avandia Increases Bone Risk for Women

I was in the supermarket the other day and ended up talking with a woman about arthritis.

She continued to tell me all the drugs she was taking and I happened to ask if she knew what Stevens-Johnson Syndrome is. She answered "No", and I referred her back to the provider to ask that question because it was a serious side effect of one of several of her prescribed drugs.

This isn't uncommon for people to be taking drugs because their provider told them they needed them for life of some other specious reason.

It isn't unlike the query in the Alzheimer's and Vitamin B3 article, "Why isn't your doctor telling you to take them?"

There are some serious vitamin and mineral deficiencies caused by the diabetes drugs. Perhaps this study is reporting on a side effect of those losses.

Bone loss added to the cardiovascular concerns with Avandia might make you sit up, take notice, and get some answers from your prescriber.

And you might also want to look at the natural things you can do to promote healing from this disease and the drugs that "manage" it.

And as for the finding that this harm does not effect men, perhaps Avandia has a major negative hormonal interference paradigm with female hormones, only aggravating the situation.

Diabetes drugs 'double bone risk' Long-term use of a class of drugs for type 2 diabetes doubles a woman's risk of breaking a bone, research suggests.

Thiazolidinediones, including rosiglitazone and pioglitzone, had already been linked to a raised risk of fractures, as well as heart problems.

UK and US researchers have quantified the risk, and showed that using the drugs for more than a year thins the bones significantly.

The study appears in the Canadian Medical Association Journal.

It found no increased fracture risk among men.

Two million prescriptions were written for rosigliatzone and pioglitazone in the UK alone last year.

The European Medicines Agency carried out a safety review of rosiglitazone and pioglitzone last year, and concluded their benefits outweighed their risks.

But the researchers argued the drugs had relatively modest therapeutic effects, and the regulators should think again.

Lead researcher Dr Yoon Loke, of the University of East Anglia, said: "Women with type 2 diabetes are already at an increased risk of fractures - with a near doubling in the risk of hip fractures - so any additional risk from thiazolidinedione therapy could have a considerable impact on public health."

Dr Loke said the underlying cause of the effect of thiazolidinediones was unclear, and required further research.

One suggestion is that the drugs may cause fractures by replacing bone marrow with fat cells.

However, he stressed women should not stop taking the drugs without first taking medical advice.

Extra fractures

The latest study, also conducted by researchers at Wake Forest University in North Carolina, examined data from 10 previous trials, involving a total of 13,715 patients.

It found that year-long thiazolidinedione use among elderly, postmenopausal women with type 2 diabetes resulted in one extra fracture per 21 women.

Among younger women, aged around 56, the figure was one extra fracture per 55 women.

There is no clear evidence that other drugs used to treat type 2 diabetes, such as metformin and sulfonylurea, cause an increased risk of fractures.

Recent research into thiazolidinediones has focused on the drugs' adverse effects on the heart and cardiovascular system.

One study found that they doubled the risk of congestive heart failure, while another found rosiglitazone was associated both with increased heart attacks and a doubling of heart failure.

Dr Victoria King, of the charity Diabetes UK, said: "We really do need further evidence through properly controlled trials before we can conclusively link thiazolidinediones to increased risk of various bone conditions in humans and determine which groups of people may be at greater risk."

In a statement, the Medicines and Healthcare products Regulatory Authority (MHRA) said fears that thiazolidinediones raised the risk of fractures in women had been raised before, and healthcare professionals notified.

The information leaflet providing with the drug to patients already contains a warning about fracture risk.

GlaxoSmithKline, which markets rosiglitazone as Avandia, said the safety and effectiveness of the drug was backed by one of the largest clinical trial programmes ever undertaken for any medicine, with 52,000 patients studied.

Story from BBC NEWS:http://news.bbc.co.uk/go/pr/fr/-/2/hi/health/7771944.stm
Published: 2008/12/10 © BBC MMVIII

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Posted in: Avandia,bone loss,drug induced nutrient depletion,health news,natural health news,natural news

OH, What A Surprise

Here is a comment from a (rare) thinking doctor from a medical poll regarding the removal of Avandia from the market.

Should the F.D.A. take Rosiglitazone off the market? Yes. Why? A drug is a drug, is a drug, is a drug. As a molecule foreign to the body, the body will fight it and reject it. This is what is called side effects. The question: Are the side effects worth the risk? The answer is: When it may cost your life, it is not worth it. The "Time Factor' built in this dilemma is just the "Clock ticking in a bomb" So open your eyes and your mind, look and find out a "good alternative". Decide, and be pleased with your decision.

This process should be used when considering any drug primarily because today's pharmaceuticals are so laden with side effects, and not just minor ones.

Bravo!

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Posted in: Avandia,health news,natural news,side effects,take it off the market,thinking doctor