>>INFORMATION: Saiontz & Kirk Avandia Blog Posts

The Avandia lawyers at Saiontz & Kirk, P.A. have been representing individuals who suffered a heart attack or other injury from Avandia since May 2007, when the first study was published in the New England Journal of Medicine about the risk of problems with Avandia. The Senate report echos allegations raised in hundreds of Avandia lawsuits filed against GlaxoSmithKline.

According to the Executive Summary of the Senate report:

[T]he reviewed evidence suggests that GSK (GlaxoSmithKline) knew for several years prior to this (May 2007) study that there were possible cardiac risks associated with Avandia. As a result, it can be argued that GSK had a duty to warn patients and the FDA of the Company’s concerns. Instead, GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cadiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.

The Senate report links Avandia to more than 300 deaths in the third quarter of 2009, and estimates that every month about 500 heart attacks and 300 cases of heart failure could be avoided if diabetes patients were given Actos instead of Avandia.

On this blog, our lawyers have been posting for nearly three years about the dangers of Avandia and the overwhelming information that supports removing Avandia from the market:

• Following publication of the May 2007 study, which indicated Avandia side effects may increase the risk of heart attacks 43%, the FDA held advisory panel meetings in July 2007 to review whether a recall of Avandia was necessary. Although the panel voted 20 to 3 that the diabetes drug does increase the risk of heart attacks, they did not recommend a recall based on the evidence available at that time.
• In October 2007, an internal FDA board narrowly voted against an Avandia recall, with the drug-safety over-sight board voting 8 to 7 against removing the diabetes drug from the market.
• In November 2007, the European Association for the Study of Diabetes and American Diabetes Association updated their “consensus statement,” urging doctors to exercise greater caution when prescribing Avandia, pointing to the increased risk of heart attacks and heart failure.
• Although the FDA did not remove Avandia from the market, doctors took the issue into their own hands and stopped prescribing the dangerous diabetes drug in great numbers during the first year after the study was released. Amid concerns that Avandia increases the risk of heart problems, prescriptions plummeted between May 2007 and April 2008.
• In August 2008, an editorial published by the medical journal Heart questioned the logic for not recalling Avandia, indicating that the justification for continuing to use the drug was weak to non-existent.
• In October 2008, the prominent consumer advocacy group Public Citizen petitioned the FDA to recall Avandia, indicating that the risk of serious and potentially life-threatening side effects outweigh any potential benefits provided by the diabetes drug.
• In November 2008, another group of researchers, who presented data on a small study at the annual meeting of the American Heart Association, questioned the benefits provided by Avandia, indicating that it provided no statistically significant reduction in plaque buildup at 18 months when compared with an older generic diabetes drug.
• In December 2008, the FDA announced new guidance for approval of future diabetes drugs, requiring new medications go through additional studies designed to provide evidence that they will not increase the risk of heart attacks or other cardiovascular events. This raised the question of whether the Avandia heart attack risk would keep the drug from being approved today.

NOTE: No decisions about whether to stop taking a medication should be made without consulting your doctor.

AVANDIA RECALL LAWSUIT

The lawyers at Saiontz & Kirk, P.A. are continuing to review potential Avandia lawsuits for individuals who have suffered a:

• Heart Attack
• Stroke
• Heart Failure
• Liver Failure
• Bone Fracture
• Vision Loss or Blindness

To review a potential Avandia recall lawsuit for yourself, a friend or family member, request a free consultation and claim evaluation.

>>INFORMATION: Avandia Fracture Lawsuits

The latest study, conducted by researchers at Detroit’s Henry Ford Hospital and published in the current issue of the Journal of Clinical Endocrinology & Metabolism involved an analysis of data on 19,000 people given oral diabetes medications. Researchers found that among users of Avandia and Actos, which are both part of the same class of medications, women faced a 50% higher risk of bone fractures, and women over 65 years-old faced a 70% higher risk.

Among prior studies and research on the risk of Avandia fracture problems:

In the December 2, 2007 issue of the journal Nature Medicine, a study provided information about the risk of osteoporosis and fractures from Avandia by evaluating mice. Researchers found that while the drug was known to inhibit the formation of new bone, it also increases bone resorption, or the breakdown of bone.

A study published in December 2008 by the Canadian Medical Association Journal, examined data on 14,000 patients from 10 prior drug trials. Researchers found that for women in their 70’s who took Avandia or Actos for at least a year, approximately one out of every 20 had a chance of suffering a fracture. For women in their mid-50s, approximately one out of every 55 women had a risk of fractures.

A study presented at a conference of the American Diabetes Association in June 2009 found a 43% increase in the risk of bone fractures among users of Avandia and Actos. Researchers also found that women were twice as likely as men to suffer bone fractures from Avandia and Actos.

In a study published in August 2009 in the Archives of Internal Medicine, researchers looked at nearly 85,000 patients and compared the bone fracture rates of patients taking Avandia or Actos with those taking another class of antidiabetes drugs known as sulfonylureas. Researchers found that users of Actos and Avandia faced a 28% increased risk of fractures.

According to a study published in September 2009 by the medical journal PLoS Medicine, which examined a database of 6 million patients from the U.K. to look at the rate of bone fractures among individuals over 40 who had been prescribed Avandia or Actos. After adjusting their findings for the likelihood of bone fractures due to age, researchers concluded that patients have a 1.5 times higher risk of bone fracture on Avandia or Actos.

AVANDIA FRACTURE LAWYERS

The risk of fractures from Avandia is a serious health concern, especially among older individuals who have taken the drug for the treatment of diabetes. Older individuals may have balance problems which make them more prone to falling and broken bones can have a much more severe effect on their health, impacting their quality of life and reducing the level of independence they are able to enjoy.

The lawyers at Saiontz & Kirk, P.A. are pursuing potential Avandia fracture lawsuits as a result of the drug makers failure to adequately research their medication or warn about the risk of this side effect. Potential Avandia cases are also being reviewed for injuries such as heart attacks, strokes, congestive heart failure, liver failure, macular edema (vision loss) and heart related death.

>>INFORMATION: Avandia Side Effects

If you, a friend, or a family member believes an injury may have been caused by the use of Avandia, request a free consultation and claim evaluation.

>>MORE INFORMATION: Avandia Liver Failure Lawsuits

The consumer group Public Citizen published a report in the current issue of the medical journal Pharmacoepidemiology and Drug Safety, identifying at least 11 cases of Avandia liver toxicity reported to the FDA’s Adverse Event Reporting System (AERS) between 1997 and 2006. However, because most patients who develop liver damage from Avandia are likely never reported, Public Citizen estimates that one in every 44,000 users of Avandia suffer liver toxicity.

This provides even more evidence that an Avandia recall is necessary, as it has also been linked to an increased risk of heart attacks, heart failure, macular edema and other injuries. Public Citizen filed a petition last year asking the FDA to issue an Avandia ban, and we raised the questions nearly 9 months ago about how long it would take the FDA to act on this petition and protect consumers.

In a press release issued last week, Public Citizen outlined some of the many reasons a recall of Avandia should be issued:

In 2006, the number of prescriptions filled for the drug peaked at 13.2 million. That number dropped to 3.1 million in 2008. This means that about 8,500 prescriptions a day are still being filled for this dangerous drug.

Liver toxicity is only the most recently noted danger of Avandia; Public Citizen has encouraged diabetes sufferers to avoid taking the drug because it increases the risk of heart attack approximately 40 percent, doubles the risk of heart failure and bone fractures, and increases the risk of anemia and vision loss from macular edema, a swelling of the retina caused by fluids accumulating in the eye. There were 39 times more reports of macular edema per million prescriptions filled for Avandia than for an older diabetes drug, glipizide.

AVANDIA RECALL LAWYERS

The Avandia lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits for liver toxicity, liver damage and death caused as a side effect of Avandia. Lawsuits are also being evaluated for users who suffered a heart attack, stroke, congestive heart failure, vision loss known as macular edema and severe injuries from bone fractures.

To review a potential case for yourself, a friend or family member, request a free consultation and claim evaluation.

>>INFORMATION: Avandia Side Effects

Avandia (rosiglitazone) was once one of the best-selling diabetes drugs, generating annual sales of over $2.2 billion. However, over the last two years, sales have plummeted and there have been calls for an Avandia recall to be issued since the risk of fatal side effects outweigh the potential benefits provided by the drug.

Most of the safety concerns with Avandia have focused on the heart side effects, with the drug receiving black box warnings about the potential to increase the risk of congestive heart failure and heart attacks. While prior studies have suggested a link between Avandia and vision problems, the new study confirms that the drug is associated with an increased risk of diabetic macular edema.

The study looked at the effect diabetes drugs known as glitazones, which include Avandia and Actos. Out of 170,000 diabetes patients identified by researchers at Kaiser Permanent Southern California, they identified 996 new cases of macular edema that occurred in 2006.

Users of Avandia and Actos were found to be between 2.4 and 3 times more likely to suffer the vision loss than those who did not use the drug.

AVANDIA MACULAR EDEMA LAWYERS

The Avandia lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits for users of the drug who have suffered vision loss or been diagnosed with macular edema. If you, a friend or family member have experienced problems, contact one of our attorneys to find out if financial compensation may be available. Request a free consultation and claim evaluation.

>>INFORMATION: Avandia Heart Attack Lawsuit

Avandia (rosiglitazone) was approved by the FDA in 1999 for treatment of type 2 diabetes. The drug increases the body’s sensitivity to insulin and aids in the management of blood sugar levels. However, side effects of Avandia have been associated with an increased risk of heart attacks, congestive heart failure, liver failure, bone fractures, vision loss and death.

Under the new guidance, the FDA is recommending that drug makers conduct “more robust and adequate design and data collection approaches” to make sure that the drugs do not increase the heart risks when compared with older treatments. This will require testing on a greater number of high-risk diabetes, including elderly patients and those with more advanced diabetes and renal impairment. In addition, they will need to have independent cardiologists evaluate any cardiovascular events.

The new guidance only applies to drugs under development which have not already been approved by the FDA. However, in a statement released Wednesday, the drug regulatory agency indicated:

The FDA remains confident that currently marketed antidiabetic therapies are safe and effective when used according to approved labeling and advises patients to work with their healthcare professionals to select the most appropriate therapy to achieve adequate blood glucose control. The FDA is continuing to evaluate how today’s recommendations will be applied to already approved antidiabetic drugs and expects to release further guidance on this issue in the future.

There is currently a petition before the FDA calling for an Avandia recall, which was filed in October and it appears very unlikely that Avandia ever would have been approved under the new FDA standards if it was in development today.

Avandia already carries “black box” warnings about potential side effects which increase the risk of congestive heart failure and heart attacks. In addition, the American Diabetes Association has unanimously recommended against the use of Avandia because of concerns about the heart risks and the availability of other safer drugs which can help manage blood sugar levels.

So the question is, how much longer will Avandia be permitted to remain on the market? There are still approximately 10,000 prescriptions for Avandia filled every day, despite the fact that a number of experts have concluded that it is an “unacceptably dangerous drug.”

AVANDIA HEART ATTACK LAWSUITS

The Avandia lawyers at Saiontz & Kirk, P.A. represent individuals who have suffered a heart attack, congestive heart failure, liver failure, macular edema, bone fractures or death as a side effect of Avandia. Lawsuits are being reviewed for individuals throughout the United States, and there are no fees or expenses unless a recovery is obtained.

To review a potential Avandia heart attack case, request a free consultation and claim evaluation.

>>INFORMATION: Avandia Lawsuits

The new research was conducted by Dr. Sonal Singh and colleges at Wake Forest University School of Medicine. Their findings, which appear online in the Canadian Medical Association Journal, found that women taking Avandia or Actos, another drug in the same class of medications as Avandia, could double their risk of a bone fracture when compared with the normal risk for their age groups.

For women in their 70s, researchers found that one out of every 20 women taking the drugs for at least one year could suffer a fracture. For women in their 50s, the risk is one out of every 55 women.

Prior studies have linked Avandia side effects to bone fractures, and a study published in the December 2007 issue of the journal Nature Medicine, which involved the study of mice, offered a possible explanation for this side effect. Researchers found that Avandia not only inhibited the formation of new bones, but also increased the breakdown of bones, which could lead to brittle bones that are more likely to break.

According to an article in The USA Today, Dr. Singh suggested that the Actos and Avandia fracture risk combined with the previously reported heart risks call into question the minimal benefits provided by the drugs in lowering blood-sugar levels.

In October 2008, the consumer group Public Citizen filed a petition with the FDA calling for an Avandia recall, since the risk of serious side effects outweighs the benefits of the drug, especially when it is considered that there are safer alternative treatments available.

AVANDIA BONE FRACTURE LAWYERS

If you, a friend or family member have suffered a bone fracture, heart attack, stroke, congestive heart failure, liver failure or sudden vision lose as a side effect of Avandia, you may be entitled to compensation as a result of the drug maker’s failure to adequately warn about the risks. To have our Avandia bone fracture lawyers review a potential claim, request a free consultation.

>>INFORMATION: Timeline of Avandia Heart Side Effects

The study was released this week by The Archives of Internal Medicine comparing the rate of congestive heart failure and death among users of Avandia and Actos.

Both drugs are part of a newer class of diabetes drugs known as thiazolidinedione agents, and both medications carry prominent “black box” warnings about the increased risk of congestive heart failure.

Researchers found that when use of the two medications is compared, users of Avandia face a 13% greater risk of heart failure and 15% higher rate of death. The study was based on data from 28,000 Medicare patients who were over 65 years old.

Last month, Public Citizen, a prominent consumer advocacy group, filed a petition with the FDA calling for an Avandia recall due to a number of serious and potentially life-threatening side effects, including an increased risk of heart attacks, heart failure, liver failure, bone fractures, vision loss and death. The petition indicated that the risks posed by the side effects of Avandia outweigh any potential benefits provided by the drug.

According to a report in the New York Times:

Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said he hoped this study would be ‘the last nail in the coffin of this drug.’

‘The big attraction of these drugs is that they are insulin-sensitizing drugs and forestall the time when someone would have to go to insulin,’ Dr. Wolfe added. ‘But with a 15 percent excess mortality of over even [Actos], which itself is dangerous, that doesn’t seem like a very good tradeoff.’

AVANDIA HEART FAILURE LAWYERS

The Avandia lawyers at Saiontz & Kirk, P.A. have been representing individuals who suffered injuries after taking Avandia since May 2007. Potential Avandia lawsuits are being reviewed throughout the United States, as GlaxoSmithKline has failed to adequately warn about the dangers of their medication and has fought to keep it on the market despite known side effects that justify an Avandia recall.

If you, a friend or family member have suffered from side effects of Avandia, request a free consultation and claim evaluation.

>>INFORMATION: Avandia Lawsuits

At the annual meeting of the American Heart Association in New Orleans, researchers presented data from a study that compared Avandia to an older generic diabetes drug glipizide, measuring the differences in the buildup of heart artery plaque.

While the study was small in size, only involving 672 people, researchers indicated that Avandia provided no statistically significant reduction in the plaque buildup at 18 months compared with when the study started. Avandia did show a slight reduction, compared with a very small increase for those on glipizide, but researchers indicate that the difference between the two drugs was so small that it does not reach the threshold of statistical significance.

These findings may not normally have a huge impact on future sales for a drug, but in Avandia’s case, this could be one more nail in the proverbial coffin.

Last week the consumer group Public Citizen filed a petition with the FDA calling for an Avandia recall, stating that any potential benefits of the drug are now outweighed by the risks, which could include a heart attack, congestive heart failure, liver failure, bone fractures, vision loss or death.

In addition, the American Diabetes Association and the European Association for the Study of Diabetes removed Avandia from their list of recommended treatments for type 2 diabetes last month. As a result of the safety concerns surrounding Avandia, the groups unanimously advised against further use of the drug.

When concerns about a potential increased risk of heart attacks associated with Avandia surfaced last year, the FDA briefly considered removing the drug from the market. However, after a narrow vote, and heated internal debate within the agency, the drug regulators decided not to issue an Avandia recall, and instead placed a black box warning prominently on the label.

With the recent decision by the American Diabetes Association, the Public Citizen petition and these latest findings which question the extent of benefits provided by Avandia, hopefully the FDA will act quickly to reconsider whether the drug should still be available.

AVANDIA LAWYERS

The Avandia lawyers at Saiontz & Kirk, P.A. are investigating potential cases for users of the diabetes drug who suffered:

• Heart Attack
• Liver Failure
• Stroke
• Heart Failure
• Vision Loss, known as Macular Edema
• Bone Fractures
• Death

To review whether you, a friend or family member may be eligible for compensation through an Avandia lawsuit, request a free consultation and claim evaluation.

Avandia (rosiglitazone) was approved by the FDA in 1999 for treatment of type 2 diabetes by controlling blood sugar levels. However, since May 2007, substantial concerns have emerged regarding a number of potentially fatal Avandia side effects.

The Public Citizen petition indicates that Avandia should be banned because the health risks outweigh any potential benefits it may provide. In addition to previously reported risks, like an increased risk of heart attacks, congestive heart failure, bone fractures and vision loss known as macular edema, Public Citizen pointed to new concerns about an association between Avandia and liver failure.

From a review of the FDA Adverse Event Reporting System, Public Citizen was able to identify at least 14 cases of Avandia induced liver failure, including 12 deaths.

Public Citizen is a prominent consumer advocacy group which represents over 80,000 consumers in the United States. The Health Research Group of Public Citizen has previously taken similar actions to push for regulations that protect the public against ineffective and unsafe drugs and medical devices.

In 2006, Public Citizen filed a similar petition with the FDA calling for a Black Box tendon rupture warning for Levaquin and other antibiotics belonging to a class of medications known as fluoroquinolones. However, it was not until July 2008, over two years later, that the FDA announced that they would require the manufacturers to add almost the exact same warnings that Public Citizen had requested.

Potentially hundreds of users could have suffered debilitating Levaquin tendon ruptures as a result of the drug makers’ failure to adequately warn about this risk and the FDA’s failure to act on the petition for two years.

Last year, following the emergence of concerns about the heart risks associated with Avandia, the FDA narrowly voted against an Avandia recall and allowed the drug to stay on the market with a black box warning about the risk of heart attacks and congestive heart failure.

Several experts who have advocated for a recall suggest that as many as 100,000 Avandia heart attacks could have been caused by side effects of the diabetes drug since it was first approved in 1999. With 10,000 Avandia prescriptions continuing to be filled every day, how many more people must suffer heart attacks, liver failure or death before the drug will be removed from the market?

AVANDIA RECALL LAWYERS

The Avandia lawyers at Saiontz & Kirk, P.A. represent individuals throughout the United States who are pursuing an Avandia lawsuit after suffering a heart attack, heart failure, stroke, bone fracture, blindness, liver failure or death.

If you, a friend or family member suspect that an injury may have been caused by side effects of Avandia, request a free consultation and claim evaluation.

>>INFORMATION: Avandia Side Effects 

Public Citizen filed their petition yesterday after reviewing the FDA Adverse Event Report System’s MedWatch forms, which identified 14 cases of Avandia liver failure, 12 of which resulted in death.

Studies have also linked the use of Avandia to an increased risk of heart attacks, congestive heart failure, bone fractures, vision loss known as macular edema and premature death.

The Avandia lawyers at Saiontz & Kirk, P.A. have been representing users of Avandia for 18 months and have investigated several cases involving clients who have been diagnosed with liver failure.

Although GlaxoSmithKline has known that Avandia is chemically related to Rezulin, which has been associated with an increased risk of liver failure, they have failed to adequately warn about this side effect.

Symptoms of a Avandia liver failure could include jaundice, disorientation, confusion, fatigue, bleeding easily, swollen abdomen, nausea, diarrhea and coma.

AVANDIA RECALL LAWYERS

Public Citizen has asked the FDA to take swift action to recall Avandia due to all of the life-threatening side effects associated with the drug. Following reports of heart attacks caused by Avandia side effects, the FDA narrowly voted against an Avandia recall last year.

Since that time evidence has continued to emerge establishing the unreasonable risks associated with the Avandia. However, there are still approximately 10,000 prescriptions filled for the drug every day.

Last week, the American Diabetes Association and the European Association for the Study of Diabetes dropped the drug from their consensus statement on type 2 diabetes treatment, unanimously recommending against use of the drug.

If you, a friend or family member have suffered a heart attack, liver failure, stroke, bone fractures or blindness (macular edema), you may qualify for compensation through an Avandia lawsuit. To speak with an attorney and review a potential case, request a free consultation.