Should I Stop My Diabetes Medicine? FDA Hearings to Determine Risk of Heart Attack

Today marks the beginning of FDA hearings on Avandia (rosiglitazone), a popular drug for diabetes. The hearing centers on whether Avandia places a patient at higher risk of a heart attack.

Patients taking Avandia may not realize that one of the primary reasons doctors use Avandia is not only to lower one’s blood sugar, but to thereby prevent heart attacks. Thus the question is highly relevant for every diabetic taking this medication.

There is no question that Avandia lowers blood sugar – that is easily proven. The blood glucose-lowering effects can be demonstrated over the course of weeks and months, with evidence of on-going decrease in blood sugar levels for years. And since it is well known that high blood sugar (diabetes) is associated with increased risk of heart attacks, it is only logical that lowering blood sugar levels should decrease the risk of heart attack (myocardial infarction).

Yet this is not necessarily so. Might Avandia be doing something else as yet unidentified within the body? This is often the case with drugs. In fact, it has long been known that taking Avandia increases the risk of liver problems. That is why your doctor checks the liver enzymes in your blood frequently. In certain patients Avandia also causes fluid retention that in some cases is associated with congestive heart failure. Clearly, Avandia does do something in the body besides lower blood sugar, but the question remains, which is more dangerous: to take the medicine or not?

There are many medications on the market for diabetes. Of course, insulin is the prototype and some might think the final answer. But patients do not like to inject themselves and so a number of oral medicines have been developed. Also, taking insulin tends to cause weight gain in Type 2 diabetics, and since weight gain is a big part of the problem to begin with, to some degree it worsens the situation.

Knowing all this, should you stop taking Avandia? At this point the answer is we don’t know. Since the drug was released I have seen a very few patients suffer from excess fluid retention, but since that problem was recognized, the drug has not been advised for patients with swelling or heart failure. To date, only a few of my patients have had abnormal liver tests, and these have all been reversible with discontinuation of the drug. For my patients, Avandia has been effective at lowering blood sugars.

Yet the question remains, what about heart attacks? This week the FDA will be reviewing data from scientific trials regarding the use of Avandia (rosiglitazone), as well as health claims data related to its use. When all the information is gathered, statisticians and physicians will have more accurate information on which to make an informed decision. If we already knew the answer, the hearings would be unnecessary.

But what should you do in the meantime? Here is one way to think about the problem: if the answer has not become clear over 10 years of use in millions of patients, the risk cannot be extremely high and is unlikely to be an immediate danger. Therefore, you have time to discuss this with your doctor. It may well be that certain patients are at risk, whereas others are not. Identifying these subgroups may be the key. Simply stopping Avandia and allowing your blood sugar to run high is definitely not a smart move. If you are afraid of the drug, see your doctor to develop an alternative plan. If you have done well on Avandia and are hesitant to change medication, keep in mind that we don’t yet have proof of increased risk. Keep your eye on the news for analysis of the data, and talk with your doctor at your next appointment.

Copyright 2010 Cynthia J. Koelker, M.D.

How Avandia Treats Type 2 Diabetes

Avandia is a oral anti-diabetic drug that is used to treat type 2 diabetes. The drug has recently been the subject of a report that suggests that it may increase the chance of heart failure. This article will look at how Avandia treats type 2 diabetes. The article also deals with what to do if you are currently taking the drug in the light of this new information.

It is estimated that some 18 million Americans and 200 million worldwide are afflicted by type 2 diabetes. It is the most common form of the disease and is one of the fastest growing diseases according to the World Health Organization (WHO) that estimates the number of people afflicted by the disease in 2030 to be around 366 million. Type 2 diabetes is an advanced form of insulin resistance. Insulin is required by the body to convert glucose to energy. A by-product of this is that the level of glucose is lowered in the blood. People with type 2 diabetes produce insulin but it is either ineffective or is at an insufficient quantity. The body is said to be resistant to insulin and some form of drug is needed to help regulate the blood glucose level.

In America, Avandia has been used to regulate the blood glucose level after it was approved by the Food and Drug Administration (FDA) in 1999. It has proved a popular drug since that time and millions of prescriptions have been written for it.

Avandia is the trade name of the pharmaceuticals company GlaxoSmithKline for the generic drug Rosiglitazone. Rosiglitazone is often termed an insulin sensitizer because it attaches to insulin receptors on cells (the peroxisome proliferator-activated receptors (PPARs)) that make them more responsive to insulin. This has the effect of utilizing the glucose to provide energy while reducing the glucose level in blood.

Rosiglitazone therapy is usually started at 4 mg/day. It is taken in tablet form once or twice a day before or after meals.

The controversy over this drug started with the release of the New England journal of Medicine report on 21 May 2007 that suggested that there was a 43% increased risk of heart attack for users of Rosiglitazone by comparison to other diabetic drugs or placebo cases.

The FDA has issued an alert over Rosiglitazone. It has stated that it will continue to study the findings over the drug but that people taking the drug should consult their doctor. People that have suffered any form of heart problems and take this drug should definitely see their doctor. The American Diabetic Association has also advocated a don’t panic attitude; consult your doctor but don’t stop taking your prescription unless advised by a qualified medical practitioner.