Avandia Heart Attacks – Avandia Stroke – Avandia Deaths
In February 2010, an Avandia FDA warning was released informing consumers and healthcare providers that it is now reviewing the primary data from a major study, known as the RECORD study, linking the type 2 diabetes drug Avandia to an increased risk of life-threatening side effects, including heat attack, stroke and death. The alert came shortly following an article in The New York Times revealing confidential government documents recommending an immediate recall for Avandia treatment.
For several years, the FDA has been working to determine whether Avandia should remain on the market and whether the drug increases the risk of heart failure and other fatal cardiovascular events as suggested by a number of clinical trials, which have been ruled inconclusive.
Although the FDA has not yet mandated a recall, in its latest press release the agency recognized that Avandia does, in fact, increase the risk of heart attack and stroke. Indeed, the FDA has acknowledged that by 2007 more than 83,000 Avandia heart attack victims had experienced this severe cardiovascular event as a direct result of the drug's serious side effects. The agency is expected to announce its decision and crucial safety data in July 2010.
Avandia RECORD Study
The RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes) study results were submitted to the FDA in August 2009. They indicated that Avandia patients are twice as likely as control subjects to suffer congestive heart failure. The study included diabetes patients between the ages of 40 and 75 with a body mass index of more than 25.
Avandia TIDE Study
The TIDE (Thiazolidinedione Intervention with Vitamin D Evaluation) clinical trial began in 2009, and its final results are not expected until 2015. According to the FDA, the TIDE study, which is a double-blind, large-scale, direct comparison between Avandia and Actos, may provide additional information on the potentially deadly complications that may be the cause of hundreds of Avandia deaths each month. The Avandia heart attacks trial will focus on the increased cardiovascular risk and the effects of long-term supplementation of vitamin D on death and cancer. The TIDE study is being sponsored by GlaxoSmithKline.
Avandia Heart Attack Symptoms
If you or a loved one is experiencing the following symptoms while using Avandia, please consult a medical professional immediately or call 911:
- Chest discomfort/pain
- Discomfort in upper body areas: arms, back, neck, jaw and stomach
- Shortness of breath
- Sweating, nausea and lightheadedness
- High blood pressure
- Fluid in the lungs
How Does Avandia Increase the Risk of Heart Failure/Stroke?
Although critics argue that there is no direct evidence on the mechanism by which Avandia leads to heart attacks, the latest FDA safety report indicates that Avandia may have an adverse effect on several body functions that lead to heart attack and stroke. Specifically, Avandia may:
- Affect serum levels (cholesterol)
- Increase the heart's demand for oxygen
- Lower hemoglobin — iron-rich protein found in red blood cells
- Increase psychological stress
All of the above symptoms may lead to an increased risk of myocardial ischemia, heart attack or heart failure. Avandia stroke victims may also suffer their serious illness as a result of these symptoms.
Heart Attack
A heart attack, also known as a myocardial infarction, occurs when a section of the heart muscle is blocked, preventing oxygen from reaching the heart, at which point the muscle begins to die. Avandia heart attack cases may be the result either of a chemically induced increase in the heart's demand for oxygen or of increased cholesterol levels.
Heart Failure
Heart failure is any condition in which the heart struggles to properly pump blood. Heart failure generally develops over time, weakening the heart and its ability to function. Studies have shown that Avandia may be linked to more heart failure cases than heart attacks.
Stroke
A stoke is a cardiovascular condition in which the blood cells carrying oxygen to the brain are blocked. Avandia stroke victims may experience a number of debilitating conditions, including permanent paralysis and death.
Myocardial Ischemia/Angina
Myocardial ischemia (angina) refers to pain in the chest due to lack of blood reaching the heart. Angina is not a heart attack, but it may lead to this potentially fatal event when left untreated.
Avandia Heart Attack – Avandia Stroke – Avandia Death Lawsuits
Attorneys are currently reviewing potential Avandia side effects lawsuits and claims against GlaxoSmithKline. If you or a loved one has suffered a heart attack, congestive heart failure, stroke, liver failure, blindness, broken bones or Avandia death, please find an Avandia attorney.
Page Updated June 24, 2011
