Articles Posted in Avandia

In a victory for consumers, the FDA finally restricted sales of Avandia in the United States (as well as suspending all use in Europe.)

However, as noted in the New York Times, the dangers associated with Avandia only came to light after a cardiologist analyzed data from clinical trials that GlaxoSmithKline, the maker of the drug, had been forced to post on its website as a result of the legal settlement. “Such public postings are increasingly the norm which means that drug makers can no longer easily hide or control scientific information about their medicines.” (Emphasis added.)

After engaging in an 11-year cover up of these health risks, “the decision brought an end to one of the worst drug safety tragedies in our lifetime.” One study estimated that from 1999 to 2009, more than 47,000 people taking Avandia needlessly suffered a heart attack, stroke or heart failure, or died.”

Despite the victory, the FDA’s actions still display willingness to compromise with the drug industry. As noted by Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group, “The FDA made progress by highlighting the risks of using Avandia and severely restricting its use, but it didn’t go far enough. Too many people could still be exposed to this dangerous product.

As New Mexico personal injury attorneys concerned about dangerous drugs, we agree. Restricting Avandia is a major step forward for consumers. However, the fact that the drug remains on the market and that the dangers of Avandia would not have come to life but for litigation underscores how far we still have to go to protect citizens from corporate greed and conflicts of interests that place profits ahead of consumer safety.
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Last week the Food and Drug Administration (FDA) advisory panel recommended that Avandia – a popular diabetes drug linked to higher risk of heart attack – contain either stronger warning labels or restrict its use.

Avandia is developed and manufactured by GlaxoSmithKline.

In addition to a well-documented increased risk of heart attack, Avandia has been shown to lead to other health complications such as:
• Stroke
• Congestive heart failure
• Liver damage
• Swelling of arms and legs

In the wake of last week’s recommendation for stronger warning labels, the FDA has put a hold on the long-term TIDE study, which compared Avandia with a similar diabetes drug, Actos. Critics have long questioned the ethics of using diabetic patients as “human guinea pigs” to assess the level of risk associated with taking Avandia.

As New Mexico personal injury attorneys concerned about dangerous drugs, not only do we support stopping the clinical trials of Avandia which continue to put more consumers at risk, but believe this dangerous drug must be taken off the market before more people suffer deaths ad serious injuries as the result of Avandia.
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This past week new studies reported that Avandia poses a substantially greater risk of heart attacks for its users. Avandia is a diabetes drug prescribed to thousands of diabetics in New Mexico and throughout the United States.

In one study, published by the AMA, researchers studied more than 227,000 people who took Avandia and found a significantly increased risk of stroke, heart failure and death.

In another study, published in the Archives of Internal Medicine, confirmed Steven Nissen’s 2007 report indicating that Avandia can increase the risk of heart attack by 43%.

However, recent statements by the FDA indicate that even where studies indicate a product is dangerous, little urgency exists to remove it. The head of FDA’s drug approval division, Janet Woodcock defends Avandia’s safety, stating its benefits still outweigh its risk. With Avandia, several years of reports and thousands of lawsuits have provided both concrete and anecdotal evidence of the potentially fatal side effects of the drug.
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According to Bloomberg News, 94% of researchers who found positive results from using Avandia had financial ties to pharmaceutical companies. Avandia, is a controversial diabetes drug that has been linked to increased sharp increased risk of heart attack and death.

Despite the FDA’s issuance of a formal safety alert concerning the risks associated with Avandia, GlaxoSmithKline continues to market and sell the drug.

The FDA has now also decided to hold public hearings in July to determine whether Avandia should be removed from the market after scores of lawsuits in New Mexico and across the country have been filed based on the increased risk of heart attack resulting from Avandia usage, along with several studies showing a substantial correlation.

While reviewing documents in preparation for the hearing, Mayo Clinic researchers noted that an astounding 45% of the researchers who had weighed in on the Avandia controversy had financial conflicts of interests and about a quarter of those failed to report those conflicts.
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The U.S. Senate Finance Committee has recently issued a report on Avandia, a controversial drug produced by GlaxoSmithKline (“GSK”) to control diabetes.

According to the report, GSK knew of possible heart attack risks tied to Avandia many years before the information became public.

The report unequivocally states “GSK had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner.”

However, according to the report, GSK failed to warn patients and states: “GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug ACTOS (pioglitazone) might reduce cardiovascular risk.”

This latest report reveals in great detail the length that pharmaceutical companies are willing to go to avoid revealing legitimate health risks associated with their drugs. It further exposes the widespread practice of pharmaceutical companies using supposedly “independent” scientific research to bolster their claims, when in actuality the company has sponsored the research.

Adding to the controversy, questions remain why the U.S. FDA continued to allow clinical trials of Avandia even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007.

In addition to heart attacks, Avandia has been linked to several significant health risks including:

• Congestive heart failure
• Liver damage
• Increased cholesterol levels
• Swelling of arms and legs
• Anemia
• Fluid retention
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A soon to be published report by the American Diabetes Association has found that the number of heart attacks by diabetic patients who took Avandia is double that of those who took a different oral diabetic medication. In the study, Harvard University researchers analyzed clinical data from more than 26,375 patients from 2000 to 2006 in the Boston area who took at least one oral diabetes medication. Of these patients, the incidence of heart attack among Avandia users was more than double that of those who used a different drug.

Further, a jointly sponsored study by both GlaxoSmithKline and i3 Drug Safety showed that diabetic patients who took Avandia had a 35-41% increased risk of heart attack over users of Actos, Avandia’s main competitor.

These findings reinforce the claims of thousands of former users – that Avandia causes serious illnesses and complications, including heart attack and death, within an already vulnerable population. In fact, over 13,000 former Avandia users have filed claims against GlaxoSmithKline in both Federal and State court as the result of significant illnesses and complications.

However, despite these known, life-threatening dangers associated with Avandia, GlaxoSmithKline still continues to market and sell the drug, placing thousands of people at risk. This is unacceptable.
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