But don’t expect physicians to write as many prescriptions for the Type 2 diabetes drug as they have in the past. Avandia brought in $1 billion in sales last year with more than 2 million prescriptions filled. But studies showing heart attacks, strokes and cardiovascular-related deaths in people who used Avandia have prompted national experts in a Consensus Statement of the American Diabetes Association to unanimously advise that GlaxoSmithKline’s blockbuster medication not be used.

While Avandia will still be available, the FDA vote showed a strong majority – 21 out of 33 members – believe Avandia increases heart risk. Twelve out of 33 members voted to take it off the market, and 10 out of 33 voted to leave it on with strong restrictions.

And while the FDA advisory panel heard damning evidence on the safety of Avandia, it was reported that GSK had agreed to settle some 10,000 of the 13,000 lawsuits filed against it alleging that Avandia caused heart attacks or strokes.

What diabetics should glean from the vote is that they need to be aware that there is a dark cloud of suspicion hanging over the safety of Avandia, which should be enough evidence for them to consider the many safer alternatives on the market.

SOURCE: Avandia Recall › Dark cloud hangs over Avandia despite FDA vote to keep it on market

Avandia was approved by the Food and Drug Administration (FDA) in 1999 to treat Type 2 diabetes, the fastest growing form of diabetes. GSK launched a multimillion-dollar ad campaign to introduce the drug to the market, which brought in $1 billion in sales last year alone with more than 2 million prescriptions filled.

A 2007 study found that Avandia could increase the risk of heart attack by as much as 43 percent, and more recent studies suggest that Avandia may be responsible for thousands of cardiovascular events such as heart attacks, strokes and other heart problems. In 2007, an FDA panel reviewed the data but voted not to pull the drug off the market.

However, concerns over a new study on the drug has led the FDA to conduct a second review the safety of Avandia. The agency is also questioning whether GSK tried to cover up the risks associated with the drug.

The panel is expected to vote soon on whether to remove the popular diabetes drug from the market.

SOURCE: Avandia Recall › GSK to pay $460 million to settle Avandia lawsuits

Avandia, also known by the generic name rosiglitazone, faced the same panel in 2007, which voted 22-1 to keep the drug on the market despite a separate vote of 20-3 that there probably was a link to heart problems. Since then, several publications have come out both in support of and against the safety of Avandia. One major topic of this second go-round with the panel includes an analysis of the RECORD study, which the Food and Drug Administration’s Dr. Thomas Marciniak of the division of cardiovascular and renal products wrote, “was inadequately designed and conducted to provide any reassurance about the (cardiovascular) safety of rosiglitazone.”

The 5 ½-year RECORD study involved nearly 5,000 diabetes patients and showed that the drug was not related to an increase in cardiovascular events other than congestive heart failure, which is a documented side effect of drugs used to treat diabetes.

Avandia is a blockbuster medication approved in 1999 to treat Type 2 diabetes, the most common form of the disease. More than a million people in the U.S. have taken the drug. Studies have concluded that Avandia raised the risk of heart attacks in people who used the drug by as much as 43 percent compared to people taking no diabetes medication or other diabetes drugs. Studies have also indicated that Avandia might increase the risk of heart-related deaths.

However, GSK backs the RECORD study, which the FDA argues is “inappropriate and biased.” The panel is expected to vote soon whether to pull the popular diabetes drug off the market.

SOURCE: Avandia Recall › FDA panel to decide fate of diabetes drug Avandia

According to the FDA’s announcement, the “FDA previously communicated to the public about the possible association between rosiglitazone and increased cardiovascular risk in a 2007 safety alert. The agency also sought advice from external experts at the July 30, 2007, joint meeting of the FDA Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. The RECORD study data represent the only new information from a completed randomized, controlled clinical trial of rosiglitazone received by FDA since the 2007 announcements.”

The RECORD study, which stands for Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes, was designed to evaluate the cardiovascular safety of rosiglitazone. This practice is consistent with the FDA’s December 2008 Guidance for Industry that recommends that manufacturers of new treatments for diabetes carefully design their clinical trials to include an evaluation of cardiovascular safety.

Once the FDA has completed its review of rosiglitazone, the agency will present its findings at a joint public meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees in July 2010.

Rosiglitazone, a treatment for Type 2 diabetes, is sold as a single-ingredient product under the brand name Avandia, and is available in combination with other diabetes medications, such as metformin, under the brand name Avandament, or glimepride, under the brand name Avandaryl. The FDA advises that patients who are currently taking any form of rosiglitazone should not stop taking their medication without first talking to their healthcare professional. Any side effects with this or any other medication should be reported to the FDA MedWatch Adverse Event Reporting program at www.fda.gov/medwatch.

SOURCE: Avandia Recall › FDA announces it will review studies linking Avandia to heart attacks

Avandia was approved by the FDA for the treatment of Type 2 diabetes in 1999, and grew to become a $3 billion a year industry for GSK. In 2007, a study was published in the New England Journal of Medicine that linked Advandia to a 43 percent increased risk of heart disease. The senators contend that the London-based GSK got its hands on a copy of the report before it was published and the drug company quickly initiated a public relations push to counter any questions about Avandia’s link to increased heart risk. The drug company also urged the medical researchers who identified the risk of heart and liver problems in patients taking Avandia to stop publishing their findings.

The effort kept the drug on the market, but GSK took a near-$2 billion hit in sales in 2009. A company spokeswoman said in a statement, “the scientific evidence simply does not establish that Avandia increases ischemic cardiovascular risk or causes myocardial ischemic events … Based on the scientific evidence and a recommendation by an independent advisory committee of experts convened by the FDA, the agency has ruled that Avandia remain available to patients for the treatment of Type 2 diabetes.”

Senators Baucus and Crassley disagree. “It can be argued that GSK had a duty to warn patients and the FDA of the Company’s concerns,” wrote Baucus and Grassley in the Senate committee report. “Instead, GlaxoSmithKline executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.”

Sources:
Business Week
New York Times

SOURCE: Avandia Recall › Senators ask why dangerous Avandia was not pulled from market