Denver Colorado Avandia Lawyer Wants to Help Victims
If you or someone you love suffered a heart attack or related death potentially associated with the use of Avandia, you may want to contact Beth Klein and discuss your case. Our firm has years of experience in defective drug litigation.
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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.)
Avandia, prescribed in pill form, is the most widely used oral diabetes treatment, with 2006 sales of $3 billion. It was approved in 1999 for the treatment of Type 2 diabetes - the most common form of diabetes - and has since been taken by more than six million people worldwide.
Some 21 million people in the United States suffer with diabetes. It occurs when the body does not produce enough of the hormone insulin or does not effectively use insulin to convert blood sugar into energy.
To read the study in the New England Journal of Medicine, click here NEJM Study
Scientific America Reports:
May 22, 2007 WASHINGTON (Reuters) - U.S. health authorities were aware of heart risks linked to GlaxoSmithKline Plc's widely prescribed diabetes drug Avandia and another competitor nearly five years ago, consumer advocacy group Public Citizen said on Tuesday.
In 2002, U.S. Food and Drug Administration staff scientists called for reports of congestive heart failure to be included on the label of Avandia as well as Actos, made by Takeda Pharmaceutical Co. Ltd., the group said, citing an internal FDA document.
The group released the memo one day after researchers reported Avandia, or rosiglitazone, raises the risk of cardiovascular-related death by 64 percent and the risk of heart attack by 43 percent.
Dr. Sidney Wolfe, head of Public Citizen's Health Research Group which has been critical of Avandia for years, said the 2002 memo showed the agency failed to take the concerns of its staff scientists seriously. "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," he said in a statement.
In a letter to FDA Commissioner Andrew von Eschenbach, Wolfe urged the agency to impose the strongest warning possible -- a black box -- on both Avandia and Actos, or ban them outright.
"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," Wolfe wrote.
Avandia Diabetes Drug Heart Attack & Other Side Effects
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,"
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 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.
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:
- Renal failure
- Heart attach risk
- 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 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
May 22, 2007 UPDATED INFORMATION: 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.
Please read the complete 2007 Safety Summary, including a link to the FDA News Release and prescribing Information regarding this issue.
If you have been injured from taking Avandia:
If you or someone you love was affected by the heart related side effects of 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 Beth Klein today.
Avandia, generically rosiglitazone and made by GlaxoSmithKline, was found to have a 43 percent greater risk of heart attack and a 64 percent increased risk of heart-related death.
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