In 1999, the FDA approved Avandia® to be used in conjunction with diet and exercise to improve glycemic control. Dr. Robert Misbin, the FDA official who examined the data on Avandia® at the time of the drug’s approval, found that there was a noticeable increase in the rate of a condition known as congestive heart failure (CHF) in the study participants.
*** Avandia® Labeling Update 2/4/11: The FDA has notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of Avandia (rosiglitazone) has been added to the physician labeling and patient Medication Guide. Additionally, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:
- In patients already being treated with these medicines
- In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).
What’s the problem?
Studies conducted by GlaxoSmithKline (GSK) regarding the cardiac effects of Avandia, which date back as far as 2001, were reviewed in May 2007 by world-renowned cardiologist Dr. Stephen Nissen of the Cleveland Clinic. Dr. Nissen wrote an article in the New England Journal of Medicine, the most influential medical review magazine in the world, stating that the use of Avandia® showed a disturbing trend toward increasing not only CHF, but heart attack and stroke.The studies examined showed the increased risk of CHF to be about 700 percent, and about 50 percent for heart attack and stroke.
In June 2007, Congress held a hearing on the FDA’s safety assessment of Avandia®. During the proceeding, both FDA officials and Glaxo representatives were asked to explain why the Nissen findings were not reported sooner. The response was that they were waiting for additional studies. This angered many congressmen, including Senator Charles Grassley, who accused Glaxo and the FDA of dragging their heels while thousands may have needlessly suffered heart-related injuries.
Signs & Symptoms of Avandia Induced Congestive Heart Failure
The symptoms of congestive heart failure vary among individuals according to the particular organ systems involved and depending on the degree to which the rest of the body has “compensated” for the heart muscle weakness.
- An early symptom of congestive heart failure is fatigue. While fatigue is a sensitive indicator of possible underlying congestive heart failure, it is a nonspecific symptom that may be caused by many other conditions. The person’s ability to exercise may also diminish. Patients may not even sense this decrease and they may subconsciously reduce their activities to accommodate this limitation.
- As the body becomes overloaded with fluid from congestive heart failure, swelling (edema) of the ankles and legs or abdomen may be noticed.
- In addition, fluid may accumulate in the lungs, thereby causing shortness of breath, particularly during exercise and when lying flat. In some instances, patients are awakened at night, gasping for air.
- Some may be unable to sleep unless sitting upright.
- The extra fluid in the body may cause increased urination, particularly at night.
- Accumulation of fluid in the liver and intestines may cause nausea, abdominal pain, and decreased appetite.