The group enumerated its concerns in a full petition, citing both safety and efficacy issues. Adverse events linked to Avandia and listed in the petition include liver failure, myocardial ischemia (increased risk of heart attack), congestive heart failure, macular edema (vision loss), anemia, and bone fractures.

One new analysis of the FDA’s Adverse Event Reporting System (AERS) data revealed that of 14 Avandia users who experienced kidney failure, 12 died.

“The evidence for this unique combination of toxicities is compounded by the accompanying lack of evidence of any clinical benefit, compared to other approved drugs for diabetes,” the petition states.

The petition also refers to statements released earlier by both the American Diabetes Association and the European Association for the Study of Diabetes advising against the use of Avandia given the availability of better options.

To support its claim, Public Citizen also included a graph highlighting the dwindling sales of Avandia from the first quarter of 2006 to the second quarter of 2008. 13.3 million Avandia prescriptions were written in 2006, yet only 4.6 million were written in the last year. Avandia prescriptions have declined steadily since late 2006.

“The FDA is in possession of clear, unequivocal evidence that (Avandia) causes a wide variety of toxicities,” Public Citizen said in its petition to the FDA.

Drugmaker GlaxoSmithKline issued a response to the petition on Friday, standing by Avandia.

“The safety of patients using our medicine is very important to us. On a continual basis, an external Hepatic Safety Board reviews any adverse event report received by GSK of liver failure, liver-related deaths and liver transplants for possible relationship to AVANDIA. As recently as July 2008, this panel of experts continued to endorse a favorable hepatic safety profile for AVANDIA,” the statement said.

Public Citizen is a nonprofit consumer advocacy organization representing more than 80,000 consumers in the U.S. It was founded in 1971 to “represent consumer interests to Congress, the executive branch, and the courts.”

SOURCE: Avandia Recall › Consumer watchdog urges immediate Avandia ban

For years, GlaxoSmithKline, the manufacturer of Avandia, enjoyed stellar sales of the diabetes drug. Avandia was GSK’s second-best seller until the results of some studies surfaced that indicated the drug poses serious risks for its users.

In February of 2007, a press release issues by GSK announced a link between female users and increased risk of bone fractures, especially of the upper arms, hands, and feet.

In June of last year, an article in The New England Journal of Medicine reported that Avandia significantly increased the likelihood of heart attacks by 43% and death by cardiovascular diseases by as much as 64% in users.

The news dealt a devastating blow to Avandia. Estimates indicate that annual Avandia profits dropped by a billion pounds (nearly $1.8 billion U.S.). A growing number of lawsuits against GSK and competition from cheaper generics also threaten GSK’s numbers. It could be argued that while additional job cuts save the company some money, those cuts are only necessary to make the company’s numbers more attractive to investors.

According to the Hertfordshire Mercury, a GSK spokeswoman explained the cuts as “part of GSK’s longer-term strategy to ensure that we invest in key areas of future growth and evolve our business to compete effectively in what is a rapidly changing and challenging environment for pharmaceutical companies.”

Translated from CEO-speak, the statement seemingly alludes to all the problems pharmaceutical companies face these days — that they must appear extra-profitable to investors while sustaining aggressive ad campaigns amidst litigation and declining sales.

SOURCE: Avandia Recall › Avandia sales drop hurting GlaxoSmithKline

Initially, it was thought that rosiglitazone, the generic term for the drug that is marketed as Avandia, was serving as a governor to the bone-building process. In other words, as bones evolve in the human body (much like skin), it was originally thought that Avandia somehow contributed towards an inability to effectively regenerate bone lost in the natural regenerative process.

However, this latest conclusion-arrived at quite by accident-reveals that rosiglitazone actually contributes to bones loss over long treatment periods. Rather then prevent bone from regenerating, Avandia contributes to actual bone loss.

The finding leads to “a better understanding of the challenges associated with long-term treatment of patients with Type II diabetes,” according to Ronald M. Evans of the Salk Institute for Biological Studies in La Jolla, Calif., lead author of the report.

Researchers were conducting studies on diabetic mice, when they stumbled upon their surprising conclusion. Their findings offer hope that this aspect of Avandia as a contributor to bone loss could be further studied and isolated and, one day, ‘dialed-out’ of a future generation of drugs dedicated to the treatment of Type 2 Diabetes.

The Howard Hughes Medical Institute, and the National Institutes of Health funded the research. The findings appeared in this week’s online issue of Nature Medicine.

Researchers found that rosiglitazone-Avandia-stimulates the cells that break down bone in the body, for future regeneration. Osteoporosis occurs when the body loses more bone that it has the capacity to regenerate. Osteoporosis is of particular concern to older women, and this latest research suggests that Avandia should not be prescribed to patients with a history of osteoporosis.

Further, for Avandia patients who also suffer from chronic osteoporosis, there is now the possibility of a contributing cause to the bone loss.

It may not just be from aging. Avandia may be helping it along.

SOURCE: Avandia Recall › Avandia now linked to Osteoporosis