Avandia Heart Attack Side Effects - How Did the FDA Miss This?

"Side effects may include: restlessness, irritability, headaches, dry mouth, gastric upset, or impotency." We've all heard this statement before. It, or something similar, follows practically every prescription medication commercial advertisement on television or radio. We all know that there will be side effects to any medication, because that's the nature of our bodies. We accept these small inconveniences in exchange for the benefits of the drug in question.

We also have a national tendency to trust, with little or no question, what pharmaceutical companies tell us. Why is that? Because we have the Food and Drug Administration (FDA) watching out for us. The FDA's job is to screen all new medications for safety and efficacy. They make sure that before a drug goes to market, it has been thoroughly tested. They ensure that the manufacturer is up-front about any adverse side effects.

Recent news articles, though, cast some serious doubt on our ability to trust the FDA. Take, for example, the headlines regarding the prescription diabetes medication Avandia: "Study: Avandia Raises Risk of Heart Attack," "Diabetes Drug Avandia Boosts Heart Attack Risk, Study Finds," and "Lawmakers to Grill GlaxoSmithKline, FDA on Diabetes Drug."

Avandia is a prescription drug that works by increasing insulin sensitivity, thus allowing diabetics to utilize glucose more efficiently. It has been approved by the FDA for use in the United States since 1999. Interestingly, Avandia is in a class of drugs of which several were removed from the market due to being suspect as a cause for liver failure. One of these drugs, Rezulin, is responsible for over 500 deaths alone.

Peer-reviewed, published evidence now exists, in the New England Journal of Medicine, that Avandia may actually increase a patient's risk of heart attack by 43. The FDA reacted to these findings by simply issuing a warning and recommending that patients using Avandia consult their doctors.

Drug safety expert, Dr. Curt Furberg, requested that the FDA remove Avandia from the market. He and Dr. Bruce Psaty both pointed out that Avandia "represents a major failure of the drug-use and drug-approval processes in the United States."

So, how did the FDA miss this? Really, it's somewhat puzzling. Puzzling, considering the fact that New York Attorney General Eliot Spitzer has just settled a $2.5 million lawsuit with Glaxo for withholding results of studies on Paxil and its use in children. Puzzling, considering Dr. Rosemary Johann-Liang asked for the highest warning put on Avandia following evidence that Avandia caused swelling which could result in heart failure; FDA agents who work closely with Glaxo complained and she was removed from the position. Why wasn't the FDA looking more closely at Glaxo's studies?

We'll see how this all works out in the months ahead. Capital Hill is now involved. They have investigators probing into the issues. Change is at hand. Lawmakers feel that the FDA is too accommodating to big pharmaceutical companies like GlaxoSmithKline who, by the way, has sold $3. 2 million worth of Avandia yearly since 1999.

Our reliance on pharmaceutical companies and government agencies to manage our health is a relatively recent phenomenon. For centuries, traditional medicine held a natural approach to whole-body healing, and the synergy of nutraceuticals instead of isolating potent chemicals. Diamaxol, an herbal support for diabetes, is an example of this time-tested technology? without the side effects of dangerous drugs like Avandia.