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

The U.S. Food and Drug Administration (FDA) advised that GlaxoSmithKline, Avandia’s maker, agreed to add the new warning to the existing black box warning. But, despite the revision, the FDA will not withdraw Avandia from the market, claiming that evidence for increased heart attack is inconclusive and does not appear to be higher in Avandia than other type 2 diabetes treatments. In the meantime, the FDA asked GlaxoSmithKline to conduct a long-term study comparing Avandia with other type 2 diabetes drugs. The trial will likely commence in a year; however, full results will not be available until 2014. Patient advocates and FDA critics consider the black box warning a weak response to Avandia’s safety issues and have requested Avandia be pulled from the market.

Avandia breaks down the body’s resistance to insulin but has long been known to cause fluid retention, a major risk factor for congestive heart failure. Evidence does not indicate Avandia and other oral anti-diabetes drugs-thiazolidinediones-prevent cardiovascular risk as a result of reducing blood sugar.

The American Diabetes Association and the European Association for the Study of Diabetes released a revised consensus statement stating that emerging information suggests additional hazards associated with thiazolidedione and rosiglitazone (Avandia) and may result in increased risk of myocardial infarctions. In October, the US Department of Veterans Affairs (VA) announced it was dropping Avandia from its prescription drug formulary stating their review concluded that, in some, Avandia did not afford the same margin of safety as other diabetes medications. The VA accounted for nearly 10-percent of Avandia’s US sales.

In November, Health Canada sent a letter to Canadian health professionals advising Avandia could no longer be prescribed as monotherapy for type 2 diabetes or in combination with sulfonylurea. In May, research based on 42 Avandia studies confirmed a 43-percent increased risk of heart attack among patients taking the drug. In August, Avandia’s warning label was changed to warn that Avandia and others in its class might worsen heart failure.

A Congressional Committee Report found that company executives made a concerted effort to intimidate a diabetes expert into keeping quiet about Avandia’s safety problems, alleging that Glaxo Chief Executive Jean-Pierre Garnier and former research chief Tachi Yamada were involved. An internal government memo dated July 16, 2002 analyzed 47 early FDA reports of patients who went into heart failure and required hospitalization while taking Avandia. The report contained warnings from Federal investigators that Avandia might cause heart failure.

Over six million Americans have used the drug to treat adult-onset, or type 2, diabetes and the concern about Avandia is nothing new. The association between Avandia and increased heart failure risk has been known since 1999 when the drug was first approved.

Avandia was Glaxo’s second most popular drug in 2006, with sales of $3.3 billion. Sales have plummeted since publication of evidence linking Avandia with increased risk of heart attack and failure.

November 29th, 2007 by Staff with NewsInferno.com

SOURCE: Avandia Recall › Avandia heart attack controversy results in black box warning

Posted 05/21/2007 FDA informed healthcare professionals of a potential safety issue related to Avandia (rosiglitazone). An on-going analysis of safety data for the treatment of type 2 diabetes mellitus using Avandia showed differing rates of ischemic cardiovascular events including heart attack or heart-related adverse events, some fatal, relative to other drugs used to treat diabetes mellitus. The clinical studies reviewed to date vary with respect to their populations, treatment regimens, and length of follow-up. Based on these data, the risk of ischemic cardiovascular events due to Avandia remain unclear. Prescribers should continue to carefully make individualized treatment decisions for patients with diabetes mellitus.

May 21st, 2007 by Staff with FDA

SOURCE: Avandia Recall › MedWatch 2007 Avandia