Avandia Side Effects, Heart Attack Risks

Many of us suffer from type 2 diabetes. In fact there are about 14 million people in the United States who are in this situation and a good number are being treated with Avandia, a medicine designed to increase the body’s sensitivity to insulin. The drug was first marketed in 1999 by GlaxoSmithKline and it became so popular among physicians that more than 60 million prescriptions have been written.

Avandia, also know as rosiglitazone,  is an oral anti-diabetic agent that also improves glycemic control and reduces circulating insulin levels for those who have Type 2 diabetes and are not insulin-dependent. Avandia is sometimes prescribed with other medicines but is not used for the treatment of Type 1 diabetes.

Diabetes sufferers should know the signs of low blood sugar (hypoglycemia) and how to recognize them, including hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast heartbeat, seizure (convulsions), fainting, or coma (severe hypoglycemia can be fatal). Always keep a source of sugar available in case you have symptoms of low blood sugar.

GlaxoSmithKline reported that annual sales of the drug climbed as high as $2.5 billion in 2006. The drug's patent expires in 2012. The drug appears to be quite versatile as researchers have suggested that it could also help treat some form of Alzheimer’s disease, ulcerative colitis and even malaria.

However, there is also a history of concerns about Avandia, including questions that it might lead to an increased risk of heart attacks.  One scientific study concluded that there was nearly a 40 percent higher chance of a heart attack among Avandia users than those not on the medicine. The company itself has acknowledged there could other side effects, including peripheral edema, or problems in the extremities caused by fluid retention and swelling. Another risk is macular edema, in which there is swelling and protein buildup in the eye.

There have been numerous lawsuits filed over the effects of Avandia and it is easy to find notices about these on the Internet. If you track these over the last few years you will notice a growing number of warnings about the drug and offers by law firms to represent victims.

GlaxoSmithKline is well aware of the problem. The company notified physicians in December, 2006 of the dangerous side effects. However, the problem goes back much farther than that. If you do some research on the U.S. Food and Drug Administration web site you will find that on June 28, 2001, the FDA issued a warning to GlaxoSmithKline. The FDA told the manufacturer it was not being completely forthright in its promotional materials about the risks of the drug.

Then, in April of 2002, The FDA issued another letter about the dangers of Avandia. This one warned healthcare professionals about a change in the warning label on Avandia  in connection with the possibility of excess fluid retention and congestive heart failure in patients taking Avandia.

That was followed in December, 2002, with a letter the FDA sent to GlaxoSmithKline to include another warning paragraph on the Avandia label:

"In postmarketing experience, there have been rare reports of unusually rapid increases in weight and increases in excess of that generally observed in clinical trials. Patients who experience such increases should be assessed for fluid accumulation and volume-related events such as excessive edema and congestive heart failure."

With a history like that those of us taking Avandia should wonder just what we should do. The FDA says that it is conducting a complete investigation but for those who exhibit the symptoms of serious side effects that the FDA warns about will the results of that investigation come in time?

That there are serious, unresolved risks with the use of Avandia goes without question. On its web site the FDA lists the following organizations that are in agreement with this:

• American Association of Clinical Endocrinologists
• American College of Cardiology
• American Diabetes Association
• American Heart Association
• Endocrine Society

“FDA agrees with these organizations and is conducting a thorough investigation,” the government says on its web site.

What will be interesting is whether the government and its investigators or the legal community and its resources get to the bottom of this first.

In 2006, a "prescribing information" paper issued for Avandia from FDA's MedWatch talks about the increasing evidence of risk of cardiovascular events. This is found on page 13 of the document and highlighted in yellow by MedWatch. MedWatch is the FDA Safety Information and Adverse Event Reporting Program.

The longer Avandia and Actos have been on the market, the more evidence of adverse cardiac events, fluid retention and congestive heart failure. All of this culminated this week with the newest study on Avandia which linked it to a risk of heart attacks and death from cardiovascular events.

People who take Avandia or Actos are encouraged to call their doctors for advice on switching.



Avandia Injury