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Avandia Congestive Heart Failure, Leaking Heart Injury, Side Effects.

Avandia FDA ALERT: February 6, 2008.

Diabetes Clinical Trial Halted Due to Deaths – Avandia Safety Called into Question Again

February 6, 2008

The government announced Wednesday that the 10,000 patient ACCORD clinical trial involving diabetes treatment has been halted 18 months early due to increased risk of patients death. The trial was stopped after the Data Safety and Monitoring Board found that the rigorous treatment increased the patients’ risk of death by 25%.

The results bring into question the methods used of lowering blood sugar actually protects the heart and is very likely to call the safety of the diabetes drug Avandia into question, yet again.

Although the research does not indicate a link between Avandia use and increased deaths, Steve Nissen, who linked Avandia use to increased risk of heart attacks, states, “ "It's very hard to sort out," and "We've got to be careful not to jump to conclusions.". Nissen went on to say "Clinicians have been taught that getting to lower blood sugar is better” and “its really going to shake things up”.

Avandia was recently back in the news, when it was found that Dr Steven Haffner, admitted leaking information about a study linking the drug to a 43% greater risk of heart attacks to GlaxoSmithKline PLC 17 days before the article was published in the New England Journal of Medicine, last May.

Our law firm is currently investigating claims involving the use of Avandia and death, heart attack, congestive heart failure as well as fractures in the hands and feet. If you or a loved one has taken Avandia and experienced any of the above situations, please contact our firm today.

--------------END OF AVANDIA ALERT for Feb 6, 2008------

 

Avandia FDA ALERT: November 14, 2007.

Avandia (rosiglitazone maleate) Tablets

Audience: Cardiologists, endocrinologists, other healthcare professionals, consumers
[Posted 11/14/2007] FDA informed healthcare professionals of new information added to the existing boxed warning in Avandia's prescribing information about potential increased risk for heart attacks. The new information refers to a meta-analysis of 42 clinical studies, most of which compared Avandia to placebo, that showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. At this time, FDA has concluded that there isn't enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk to their healthcare professional about the revised warning as they evaluate treatment options. Healthcare professionals are advised to closely monitor patients who take Avandia for cardiovascular risks.

More information on the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Avandia2

 

NEWS UPDATE: July 30, 2007 Potential Recall

An FDA scientist has declared that the diabetes drug Avandia should be pulled from the market due to heart risks.

Dr. David Graham in a slide presentation illustrated that Avandia is no more affective in treating diabetes then other medications currently available on the market. Because of the known heart risks from taking Avandia he recommends it be taken off the market.

The presentation was at the beginning of a daylong meeting of a joint panel of outside experts brought together to consider whether the drug should be restricted to use in select patients and labeled with prominent warnings or removed altogether from sale.

Previously, the FDA said information from dozens of studies of the GlaxoSmithKline PLC drug points to an increased risk of heart attack.

 

UPDATE: May 23, 2007:

Public Citizen Agency asked for heart failure to be noted on Avandia labels in 2002.

Consumer advocacy group Public Citizen has released a memo a day after researchers announced Avandia or rosiglitazone increases the risk of cardiovascular-related death by 64 percent and the risk of heart attack and related heart injury by 43 percent.

In the memo Pubic Citizen stated that U.S. health authorities were well aware of heart risks linked to GlaxoSmithKline diabetes drug Avandia and another competitor nearly five years ago.

In 2002, The FDA scientists called for reports of congestive heart failure to be noted on the labels of Avandia and Actos, made by Takeda Pharmaceutical Co. Ltd., citing an internal FDA document.

The head of Public Citizen’s Health Research Group Dr. Sidney Wolfe stated the 2002 memo illustrated that the FDA failed to take its own staff scientists seriously.

To quote Dr. Wolfe: “As a result, millions of people, to the detriment of their health, are prescribed drugs whose risks are dangerously understated, instead of being prescribed safer, equally or more effective alternative drugs."

Dr. Wolfe wrote a letter to FDA Commissioner Andrew von Eschenbach asking the agency to issue the highest possible warning a drug can have, a black box warning, for both Avandia and Actos, or to even ban them altogether.

In the letter Dr. Wolfe wrote: “There continues to be no mention of the large and increasing number of post-marketing reports of heart failure, which was the explicit recommendation in the 2002 internal FDA memo.”

Related news on Avandia: Three medical organizations have issued a joint statement saying diabetes patients should stay on their medications until they speak to their doctors.

May 22, 2007 UPDATED: FDA issues Avandia Alert

The following information is directly from the FDA.

FDA informed healthcare professionals of a potential safety issue related to Avandia (rosiglitazone). An on-going analysis of safety data for the treatment of type 2 diabetes mellitus using Avandia showed differing rates of ischemic cardiovascular events including heart attack or heart-related adverse events, some fatal, relative to other drugs used to treat diabetes.  The clinical studies reviewed to date vary with respect to their populations, treatment regimens, and length of follow-up.  Based on these data, the risk of ischemic cardiovascular events due to Avandia remain unclear.  Prescribers should continue to carefully make individualized treatment decisions for patients with diabetes mellitus.

Read the complete 2007 Safety Summary, including a link to the FDA News Release and Prescribing Information regarding is issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Avandia

--------End of FDA Alert--------

 

May 21 2007 NEWS: New Avandia Heart Attack Risks Study

A pooled study on GlaxoSmithKline’s Avandia drug released by the New England Journal reflects health implications for diabetic patients. 

A cited finding reflects data from 42 studies involving 15,560 patients who took the drug and 12,283 patients who were given other medications or a placebo.  Patients getting Avandia were 43 percent more likely to have a heart attack. The study suggested trends toward higher death rates in the Avandia study group.

``The results of this analysis raise serious concerns about the cardiovascular safety'' of Avandia, known chemically as rosiglitazone, said Steven Nissen, the chairman of cardiology at the Cleveland Clinic in Ohio. ``Unfortunately, rosiglitazone appears to increase, rather than decrease, the most serious complication of diabetes, heart disease.''

American Diabetes Association reports that almost 21 million people in the U.S. have diabetes, a disease in which the body doesn't properly make or use the hormone insulin to convert blood sugar to energy.  There have been tens of millions of prescriptions for Avandia written since approved in 1999.

Avandia acts by lowering the body’s blood sugar levels, which can cause complications including kidney and eye damage, by increasing the body's sensitivity to insulin.

A statement was issued from GlaxoSmithKline: "GSK stands firmly behind the safety of Avandia when used appropriately, and we believe its significant benefits continue to outweigh any treatment risks,"

Prior Studies in the US have shown  a total of 158 heart attacks and 61 deaths from cardiovascular causes among the patients in the studies, which generally lasted from six months to a year.

First approved by the Food and Drug Administration in 1999, Avandia is a drug designed by GlaxoSmithKline intended to treat type II diabetes.  This condition, commonly called adult-onset diabetes, affects millions of people across the world.

Diabetes type II is characterized by insulin resistance, which means that the insulin in the body does not absorb glucose in the blood stream.  Avandia helps these patients moderate the amount of sugar in their body in order to prevent the serious complications type II diabetes can cause such as:

• Heart attack risks (Congestive heart failure
  Leaking heart injury)
• Renal failure
• Blindness
• Coronary artery disease
• Slow healing wounds

The symptoms of type II diabetes are often so subtle that they are confused with other, less dangerous conditions or ignored entirely.

Unfortunately, Avandia has a number of extremely dangerous and potentially-fatal side effects to the liver including:

• Jaundice (yellowing of the eyes and skin)
• Dark urine
• Fatigue
• Loss of appetite
• Nausea
• Vomiting
• Stomach pain

These side effects should be treated immediately by medical professionals as they could be signs of serious liver damage.

Furthermore, Avandia is also linked to heart failure and hypoglycemia, or extremely low blood sugar.

Heart failure symptoms include

• Chest pain
• Swelling of the extremities
• Weight fluctuations
• Difficulty breathing/Shortness of breath

Hypoglycemia symptoms include:

• Dizziness
• Headaches
• Accelerated heart rate
• Weakness
• Sweating
• Fatigue

If you have been injured from taking Avandia:

If you or someone you love was affected by congestive heart failure, leaking heart injury from Avandia, you may be entitled to financial compensation for your situation. Let our experienced and aggressive defective drug attorneys help you get the justice you deserve.  Contact our Avandia Lawyers and attorneys today.

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