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

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

“I was having severe chest pains and I was hospitalized and told at a later time that taking Avandia could cause the severe pain I was having,” Joyce says. “I thought that I was having a heart attack, but they did a stress test and said that the pain was not a heart attack. But it was something strenuous under the heart.”

Joyce says she was put on Avandia in 2002 or 2003 and was only taken off it after she was hospitalized in 2007. “The pain just got worse and worse through the years,” Joyce says. “I’m still having some small chest pains, but it’s not as serious as it was. Sometimes, I still get little ‘catches’ under my heart that haven’t completely gone away. I’m trying to take it easy, watch my weight and watch what I eat. I also had swelling in my ankles and feet. I still get that sometimes, too. But that’s not as bad as it was.

“Walking distances would cause my chest to tighten up a little bit. But, I could just be lying in bed and my chest would tighten up. Not just walking makes it tight. I was scared to do strenuous stuff because of my chest tightening up. After the last time I was in the hospital, I saw my new doctor and told him I was taking Avandia. He said, “We’re taking you off that today.’ And since then I’ve been somewhat better but I still have some pains. It hasn’t even been a good two months since I stopped taking it.

“I’m really scared of Avandia now. It’s scary when it’s messing with your heart. I think Avandia is a big risk to your health and a big risk to your heart.”

Fortunately for Joyce, she did not suffer any heart attacks while taking Avandia. Hopefully, she will make a full recovery and stop experiencing chest pains and swelling in her ankles. Other patients have allegedly suffered life-threatening heart problems while taking Avandia. Some are filing lawsuits against the maker of Avandia, alleging GlaxoSmithKline knew about the problems associated with Avandia but did not properly warn patients about those risks.

January 8th, 2008 by Heidi Turner with LawyersandSettlements.com

SOURCE: Avandia Recall › Avandia a big risk to your heart