Avandia®, which was approved on 5/25/99, is manufactured by GlaxoSmithKline and is a class of diabetes drugs called thiazolidinediones or glitazones, which increase the body's sensitivity to insulin. Diabetics with mild heart disease or any problems with their kidneys may be at an increased risk of developing congestive heart failure if they take certain diabetes medications, according to a new study.
A study, published in the September 9, 2003 issue of the Mayo Clinic Proceedings, reported on six cases of congestive heart failure in people taking Avandia® to help control their diabetes. The researchers studied the records of six men, between the ages of 66 and 78 years, with Type-II diabetes who had gone to the emergency room at Dallas Veterans Affairs Medical Center emergency room.
All six patients complained of shortness of breath, swelling of their feet, and weight gain, which are symptoms of congestive heart failure and pulmonary edema (fluid buildup in the lungs). Congestive heart failure occurs when the heart can no longer pump enough blood to maintain adequate circulation. Because the heart doesn't pump properly, fluid often builds up in the lungs.
Four of the six people in this study had chronic renal insufficiency. Only two had any previous signs of heart disease. Four of the six had high blood pressure. They had been on the diabetes medications for between one month and 16 months. Three people developed symptoms within one to three months after the dose of their diabetes drug had been increased.
The FDA and GlaxoSmithKline acknowledged on January 5, 2006 that patients who have taken Avandia® reported blurry vision and swelling of the feet and legs. More than 6 million people worldwide have been prescribed Avandia®.
GlaxoSmithKline stated they received very rare reports of new or worsening diabetic macular edema in diabetic patients who took Avandia®. The swelling of the retina can cause blurry or distorted vision. Additionally, most of those patients also reported peripheral edema, or swelling of the legs, ankles and feet, according to a letter GlaxoSmithKline sent during December 2005 to doctors. In some situations, stopping treatment or reducing the dose eliminated or improved the condition, the letter added. Reported side effects include:
- Death Edema
- Swelling of the feet
- Congestive heart failure
BCA has been involved in the screening Avandia® cases since the inception of the litigation. Our attorneys have lectured to various groups of lawyers on this subject.