Avandia, a diabetes drug already mired in controversy, may double the risk of bone fractures, according to a new study. The study, conducted by Swiss researchers, found a similar risk with the diabetes drug Actos. Previous studies have found that these drugs increase the risk of bone fractures, but the Swiss study sheds light on how serious this problem might be.

Avandia has been a subject of debate since last May, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. Last July, the Food & Drug Administration (FDA) convened a panel to discuss the issues surrounding Avandia’s heart attack risk. The panel voted 20-3 that the drug did in fact raise the chance of heart attacks, yet the panel still voted 22-1 to allow it to remain on the market. In November, the FDA announced the addition of a long-awaited black box warning for Avandia’s increased risk of heart attacks. However, many patient advocates and FDA critics thought the black box warning was a weak response to Avandia’s safety issues. These critics continue to call on both GlaxoSmithKline, the maker of Avandia, and the FDA to pull the drug from the market. One diabetes expert, Dr. John Buse, has said that in action on Avandia might be responsible for as many as 83,000 preventable heart attacks. (more…)

Avandia and Vytorin are the subject of yet another government investigation.  The Government Accountability Office (GAO) will look into whether the US Food and Drug Administration’s (FDA) drug-review process cleared two popular medications without sufficient proof of their safety or effectiveness.

Senator Charles E. Grassley (Republican-Iowa) requested the GAO investigation after recent studies suggested that the diabetes pill Avandia increases the risk of cardiac problems in patients, and another study showed that  the cholesterol drug Vytorin may not actually lower the risk of heart attack and artery-clogging plaque, as assumed by millions of patients and doctors.  “There’s enough of a pattern of problematic drugs to ask for an independent review of how the FDA follows up on the effects of medicines that it’s approved,” Grassley said.  The question is whether the FDA should approve drugs based on biological measures, such as cholesterol and blood sugar, without evidence that they improve more meaningful measures, such as survival. (more…)

Avandia lawsuits against GlaxoSmithKline over the drug’s alleged cardiac side effects are beginning to make their way through the courts,  and many more are expected.  One a man is suing GlaxoSmithKline in federal court, claiming Avandia caused him to undergo heart bypass surgery.  Attorneys allege the drug maker should have known that Avandia—prescribed to improve blood sugar in type 2 diabetes patients—is linked to a significant and increased risk of heart failure, heart attack, and stroke.

The lawsuit is among several filed nationwide targeting Avandia and Glaxo; it is believed there are thousands yet to be filed.  Over six million Americans used the drug and concern about Avandia is nothing new.  The connection between Avandia and increased heart failure risk has been known since 1999 when the drug was first approved.   Avandia sales have plummeted since publication in The New England Journal of Medicine linking Avandia with increased risk of heart attack and failure, but Nancy Pekarek, spokeswoman for GlaxoSmithKline, said the company stands by Avandia, “We are certainly confident that when the courts or the juries look at the clinical data, the responsible way in which we communicated that information, and our openness in posting our clinical trial data online, they will see our position,” she said.  The lawsuit alleges that the company “had the knowledge, the means, and the duty to provide the medical community and the consuming public with more accurate descriptive information and more adequate warnings regarding the association between Avandia and heart failure…” (more…)

A diabetes drug trial was halted recently after it was determined that trial participants receiving aggressive diabetes treatment were dying at a higher rate than those who did not receive intensive therapy.  However, researchers involved in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial were quick to assert that the controversial drug Avandia was not to blame for the deaths, and that the overly aggressive treatment administered to some participants was most likely the cause of the deaths.

The ACCORD trial, sponsored by the U.S. National Heart, Lung, and Blood Institute (NHLBI), began in 2001 at 77 sites in the United States and Canada with the enrollment of 10,251 patients with type 2 diabetes who were at high risk for heart attack or stroke because they had at least two risk factors, including high blood pressure, high cholesterol or obesity. Those in the trial received either medications to aggressively lower their blood sugar below recommended levels, or standard treatment to control their disease.  The goal of the aggressive treatment group was to lower blood sugar levels — a measure known as hemoglobin A1c — to below 6 percent, far below the current target of under 7 percent and closer to what is seen in non-diabetics. The researchers said they would now adjust the ACCORD trial so the blood sugar of patients would not be lowered so much. (more…)

Avandia could have been responsible for an additional 83,000 heart attacks.  That stunning number comes from an Avandia analysis performed by Food & Drug Administration (FDA) scientists presented at a July 2007 safety panel meeting.   The Avandia heart attack analysis is included in a report released in November by the Senate Finance Committee entitled “The Intimidation of Dr. John Buse and the Diabetes Drug Avandia.”

Avandia’s heart attack link came to light when an analysis of 42 clinical trails published by the Cleveland Clinic in May showed that patients taking the drug had a 43% higher risk of having a heart attack.  Late last year, the FDA announced the addition of a long-awaited black box warning for Avandia’s increased risk of heart attacks.  However, many patient advocates and FDA critics thought the black box warning was a weak response to Avandia’s safety issues, and have called on GlaxoSmithKline, the maker of Avandia, and the FDA to pull the drug from the market.

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GlaxoSmthKline, the maker of Avandia, and AstraZeneca, another large drug maker, are being investigated in Britain for allegedly bribing the regime of Saddam Hussein in Iraq.   The revelation of the UK bribe probe is bad news for both companies, but it especially ominous for Glaxo.  Glaxo has been sullied by the safety scandal surrounding its diabetes drug Avandia, and sales of the drug have fallen, causing considerable damage to Glaxo’s bottom line.

Glaxo is still trying to recover from its Avandia problems, and hardly needs the bad publicity of a bribery probe.  Avandia has been a subject of debate since May 21, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. Since the Cleveland Clinic study was published, a great deal of controversy has swirled around Avandia. In June, Congress held hearings to discuss Avandia and the Food & Drug Administration’s (FDA) handling of its safety issues. At those hearings, it was revealed that Glaxo had informed the FDA of a study it had conducted that produced results similar to the Cleveland Clinic study. However, both the agency and the manufacturer felt that more investigation was needed before conclusions could be made about Avandia’s possible safety issues.   As a result, the Avandia heart attack risk was not publicized until May 2007.  A black box warning about heart problems was finally added to the Avandia label in November, but since the scandal broke, Avandia sales have fallen considerably, and several large insurers have stopped paying for the drug.

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The consequences of deadly Avandia side-effects are now being seen in the general population, a new study has found.  Previously, evidence that Avandia placed patients at an increased risk of heart attacks had only been seen in clinical trials.   But now, Canadian researchers have found that patients taking the controversial diabetes drug who are not enrolled in clinical trials are showing increased evidence of heart attacks and other cardiac problems.

Avandia’s heart attack link came to light when an analysis of 42 clinical trails published by the Cleveland Clinic in May showed that patients taking the drug had a 43% higher risk of having a heart attack.  Just last month, the Food & Drug Administration (FDA) announced the addition of a long-awaited black box warning for Avandia’s increased risk of heart attacks.  However, many patient advocates and FDA critics thought the black box warning was a weak response to Avandia’s safety issues, and have called on GlaxoSmithKline, the maker of Avandia, and the FDA to pull the drug from the market.

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Avandia puts older patients at a significantly higher risk of heart attack and death, says a new study.   The research, conducted by the Institute for Clinical Evaluative Sciences in Toronto, Canada, is just the latest scientific evidence to highlight Avandia’s safety issues.  Only last month, a black box warning detailing Avandia’s heart attack risks was added to the label of the controversial diabetes drug, but that move has done little to quiet critics who believe Avandia should be pulled from the market.

Avandia has been a subject of debate since May 21, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack.  This latest Avandia study, published in the “Journal of the American Medical Association” analyzed drug use and health outcomes for 159,000 people age 65 and older treated for Type 2 diabetes in Ontario, Canada.  Of those patients, 2,268 people where being treated with Avandia.   The analysis found that for every 100 people taking Avandia over a four-year period there would be five additional deaths, four additional heart attacks and three additional episodes of heart failure.

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Avandia has taken another hit on the chin, as two large pharmacy benefit managers announced that they would be dropping the controversial diabetes drug from their value-based prescription drug formularies as of January 1, 2008 because of safety concerns.  The decision by HealthTrans Pharmacy and Prime Therapeutics to stop covering Avandia will do little to help sales of the drug, which have gone downhill since it was associated with an increased risk of heart attack in May.

Avandia’s heart attack link came to light when an analysis of 42 clinical trails published by the Cleveland Clinic in May showed that patients taking the drug had a 43% higher risk of having a heart attack.  Just last month, the Food & Drug Administration (FDA) announced the addition of a long-awaited black box warning for Avandia’s increased risk of heart attacks.  However, many patient advocates and FDA critics thought the black box warning was a weak response to Avandia’s safety issues, and have called on GlaxoSmithKline, the maker of Avandia, and the FDA to pull the drug from the market.

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Avandia places patients at a high risk of bone fractures and osteoporosis by affecting the way bone cells are replenished in the body.  While bone fractures are a well known Avandia side effect, no one understood how the diabetes medication affected bone structure.   Now, researchers at the Salk Institute for Biological Studies in La Jolla, California have discovered that Avandia affects the workings of two types of cells important to the process of replacing old bone.  They surmise that Avandia’s action on these cells, osteoblasts and osteoclasts, could account for the bone fracture risks faced by Avandia patients.

In the body, old bone cells are constantly being replaced by newer cells.  This process helps to keep bones strong and resistant to fractures.  But researchers studying the affects of Avandia on the bone structure of mice found that the medication interferes with this process in two important ways.  While it was already known that Avandia inhibited the action of osteoblasts, cells in the body that build bone,  the new research found that Avandia also appears to affect a key cellular protein called the peroxisome proliferator-activated receptor (PPAR-gamma). In their study, the California team discovered that activating this receptor in mice also stimulates the production of osteoclasts, cells whose key function is to degrade bone.  Proper bone health is maintained by a balance between osteoclasts and osteoblasts.  When this balance is upset, a patient becomes more susceptible to bone fractures, and stands a much higher chance of developing osteoporosis.

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