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New Avanida Warning Issued: February 6, 2008. 11:45 A.M. PST

Avandia Safety Called into Question Again

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.

New Avanida FDA Alert Black Box Warning: November 15, 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.

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New Avandia Heart Attack Risks Study: May 21 2007

A new study on the drug Avandia released by the New England Journal notes major health implications for diabetic patients.

The study shows data from 42 studies involving 15,560 patients who took the drug and 12,283 patients who were given other medications or a placebo.
According to this new study it was noted that patients getting Avandia were 43 percent more likely to have a heart attack.

A comment was made by Mr. 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.''

Older studies in the U.S. 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.

In December 2005, GlaxoSmithKline and FDA alerted healthcare professionals to new information regarding the potential of serious and potentially life-threatening side effects of the popular diabetes mellitus type 2 treating drug Avandia. Avandia is an oral treatment intended to control blood sugar levels that almost 5.3 million people have used since it was approved in 1999.

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UPDATE: May 22, 2007 - FDA ALERT ISSUED FOR AVANDIA

This is the actual FDA issued alert:

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

UPDATE: May 23, 2007

Public Citizen Agency asked for heart failure to be noted on 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 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 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.

Avandia Heart Failure or Damage:

The are a number of serious potential Avandia injury risks associated with this diabetes drug. Most of them affect the cardiovascular system and include:

Heart Failure or Damage
Heart Valve disease
Edema
Blood Artery disease
Heart attack

In fact, a study published by the Mayo Clinic in September 2003 reveled six people developed congestive heart failure in diabetic patients under Avandia treatment. These six men between 66 and 78 years of age all had type 2 diabetes and required emergency treatment. Congestive heart failure is a potentially fatal cardiac condition that occurs because the heart muscle cannot pump sufficient blood through the circulatory system, which causes fluid to build up in the lungs.

Other Avandia side effects may include:

Avandia is also linked to reports of diabetic macular edema, a swelling of the retina that can interfere with vision. Many patients with diabetic macular edema often complain of blurry or distorted vision, and many of these victims experienced associated Avandia side effects of ankle, leg, and feet swelling.

Find an Avandia Lawsuit Attorney

If you or someone you love was injured by this dangerous drug, you need to contact an Avandia diabetes drug attorney right away. You may be entitled to financial compensation for your Avandia heart attack, heart valve disease, edema, blood artery disease, or primary pulmonary hypertension, but if you hesitate in contacting a PPH attorney you could miss your chance for restitution. Contact our Avandia heart failure lawyers today.