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Dangerous Drugs

Affected by Avandia - We can help! The diabetes drug Avandia has been linked to serious heart issues. If you or a loved one has has suffered a stroke, heart attack or congestive heart failure (CHF) after taking Avandia, call The Johnson Firm TOLL FREE at 877.838.7032, you may be entitled to recover significant financial compensation.

Avandia - In the News

… read Chicago Tribune article (12 December 2007)>

… read Reuters article "Glaxo settles more Avandia lawsuits in U.S." (1 June 210)>

Avandia

Have you taken the following diabetes drugs and suffered a heart attack, PPH, congestive heart failure, or other serious injury?

Avandia - (generic name - rosiglitazone maleate)
Avandamet - Contains Avandia combined with metformin
Avandaryl - Contains Avandia combined with glimepiride
Actos - (pioglitazone HCl) is a type of oral diabetes agents called thiazolidinediones

Glaxo SmithKline manufactures the Avandia drugs and sells them under various generic names including Rosiglitazone Maleate. The drug is currently on the market and is approved for use to treat Type II diabetes. The drugs have extremely dangerous side effects that the manufacturer failed to warn patients or doctors of including:

• Death
• Heart Attacks
• Congestive Heart Failure
• PPH – Primary Pulmonary Hypertension
• Bone Fractures
• Hepatitis

Other Side Effects include:

• Weight Gain
• Liver problems
• Anemia
• High Cholesterol
• Edema (swelling)
• Cold-like symptoms
• Headaches
• Hypoglycemia

These dangerous drugs have been on the market since 1999. Even though Glaxo knew of the problems, they failed to provide sufficient warning to the public or to the doctors that prescribed the medication. Avandia can cause heart attacks, Primary Pulmonary Hypertension (PPH), and Congestive Heart Failure in patients taking the drug. If you have taken Avandia to help treat diabetes and have suffered one or more heart attacks or had symptoms of Pulmonary Hypertension or Congestive Heart Failure, or if you have been diagnosed with either of these serious conditions, call us today. There is a good chance you have been injured by Avandia. You need to get expert medical care and legal advice as soon as possible regarding your claim.

Avandia is prescribed to treat diabetes. Avandia was designed to lower blood sugar and help the body use naturally occurring insulin better. Avandia is sometimes combined with other diabetic medications into a single pill:

Avandamet Avandamet combines two medicines to treat type 2 diabetes Avandia (rosiglitazone maleate) and metformin in one pill.

Avandaryl Avandaryl combines two medicines to treat type 2 diabetes - Avandia (rosiglitazone maleate) and glimepiride (a sulfonylurea) in one pill.

When your doctor prescribes one of these two combinations, the medication will have a different label but still contain Avandia.

The Actos Family Avandia, made by GlaxoSmithKline (GSK), was found to have a 43 percent greater risk of heart attack and a 64 percent increased risk of heart-related death. If you have taken Actos, Avandia, Avandamet or Avandaryl and experienced one or more heart attacks, symptoms of Pulmonary Hypertension, or Congestive Heart Failure, or if your doctor has already diagnosed you with any of these conditions then call us today. Acting now could help save your life.

The diabetes drug Avandia has been associated with a significantly higher incidence of heart attacks and death, according to a major research analysis. The findings were the result of an analysis of 42 studies involving 15,560 patients who took Avandia and 12,283 who took other drugs or were given a placebo. The study was conducted by doctors at the renowned Cleveland Clinic and reported May 21, 2007 in The New England Journal of Medicine.

Update: A new study was done on the effects of Avandia by Dr. Merri Pendergrass and presented at the 2009 American Diabetes Association Scientific Sessions. The study was looking at the increased rate of bone fractures of people who were taking Avandia. This study showed that fractures increased by 40% for patients taking Avandia (rosiglitazone).

One of those who conducted the latest study, Steven Nissen, chairman of cardiology at the Cleveland Clinic, said it raised “serious concerns about the cardiovascular safety” of Avandia. (He advised that patients first consult with their doctor before discontinuing use of the medication.) Following release of the study, termed a "meta-analysis," the U.S. Food and Drug Administration issued the following warning: "Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia." The FDA said its own analysis of the drug was ongoing.

Avandia, prescribed in pill form, is the most widely used oral diabetes treatment, with 2006 sales in excess of $3 billion. The FDA approved it for use in 1999 for the treatment of Type 2 diabetes, the most common form of diabetes. Since that time more than six million people worldwide have taken Avandia.

Avandia Timeline — A summary of Avandia-related events

May 25, 1999 — The FDA grants SmithKline Beecham (now GlaxoSmithKline) the right to manufacture and market Avandia (generic name: Rosiglitazone) as a medication to treat type 2 diabetes. Shortly thereafter, SmithKline Beecham conducts a study showing Avandia to have riskier side effects to patients' hearts than the competing diabetes drug Actos.
2001 — GSK, at the FDA's request, commissions a six-year study comparing the cardiovascular outcomes of Avandia to other commonly used diabetes medicines. GSK announces that the study results show no heart risks. GlaxoSmithKline receives a reprimand from the FDA for downplaying the potential risks of heart risks associated with Avandia.
2005 — A GlaxoSmithKline analysis indicates that there may be a number of health risks caused by Avandia.
June 2004 — GlaxoSmithKline agrees to make all clinical trials available on the company website as a result of a lawsuit in which Eliot Spritzer, then New York attorney general, sued GSK for not fully disclosing that Paxil (the GSK antidepressant) caused an increase in suicidal behavior in children and teens.
February 2007 — The FDA announces that a study has found that, "Significantly more female patients who received rosiglitazone experienced fractures of the upper arm, hand, or foot, than did female patients who received either metformin or glyburide”. GlaxoSmithKline, as a result, warned healthcare providers to consider the risks of Avandia before prescribing it.
May 2, 2007 — Dr. Steven Nissen, chief cardiologist at the Cleveland Clinic, and co-author Kathy Wolski conduct an analysis of 42 clinical trials of Avandia posted on GSK's website. They submit an independent article to the New England Journal of Medicine stating that Avandia increases heart attack risk by 43 percent.
May 9, 2007 — In an e-mail statement reproduced in a January 2010 report for the Senate Finance Committee, a GSK consultant concludes by saying, "We cannot undermine the numbers but I think they can be explained so we must concentrate on effective risk management."
May 21, 2007 — The FDA publishes a letter on its website stating “safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.”
June 14 2007 — Despite GSK executives' efforts to persuade Nissen otherwise, he and coauthor Wolski publish the peer-reviewed article of Avandia's potentially dangerous side effects in the New England Journal of Medicine.
November 14, 2007 — As a result of fierce Senate Finance Committee hearings where senators accuse GSK of mishandling scientific evidence regarding Avandia and the FDA of having a conflict of interest with the drug, the FDA allows Avandia to stay on the market but with the addition of the FDA's strictest "black-box" warning label.
November 24, 2008 — Published by the Archives of Internal Medicine, a study of nearly 30,000 patients led by Dr Wolfgang C. Winkelmayer and colleagues at Harvard Medical School reveal that Avandia patients were 15 percent more likely to die and 13 percent more likely to suffer congestive heart failure than patients on Actos.
January 24, 2008 — A report citing FDA scientists is published in which the estimate of Avandia-related heart attacks is placed as high as 83,000.
February 20, 2010 — The Senate Finance Committee, after two years of hearings, accuses GSK of knowing the potential cardiac risks of Avandia, and choosing to hide that data, suppress its critics and promote sales of the drug regardless.
June 28, 2010 — Two separate studies, published by The Journal of the American Medical Association and the Archives of Internal Medicine, conclude that Avandia should be removed from the market. While another study, from a professor at University of Washington in St. Louis, argues that Avandia did not pose a significant cardiovascular risk — although this study was not originally designed to measure the effectiveness of Avandia.
July 13-14, 2010 — An FDA advisory panel recommends that Avandias should stay on the market but with new label warnings and prescription restrictions. New FDA Commissioner Margaret Hamburg gets final say on whether to enact this recommendation.
July 28, 2010 — GlaxoSmithKline sets aside $460 million in order to settle approximately 10,000 of the 13,000 Avandia-related lawsuits facing the company — approximately $46,000 per litigant.

If you or someone you love has been affected by Avandia, you may be entitled to compensation for your injury. Call – 214.468.9000 – The Johnson Firm and Price L. Johnson now to talk to an attorney that specializes in Avandia, Actos, Avandamet, and Avandaryl lawsuits.