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Possible Serious Side Effects Linked to Diabetes Drug Avandia

With more than 20 million Americans already diagnosed with the disease, diabetes represents a serious health threat, according to the American Diabetes Association. The ADA also states that there could be as many as six million more Americans living undiagnosed with the disease, as well as 40 million more individuals that could be considered pre-diabetic. Because of these ever growing numbers, pharmaceutical companies find the demand for new and innovative treatment options to greatly increased as well.

Rosiglitazone Maleate, also known as Avandia, is such a drug, developed by the drug maker GlaxoSmithKline and approved by the Food and Drug Administration (FDA) in May of 1999. The drug comes from the Thiazolidinedione class of anti-diabetic drugs and is approved for treatment of type 2 diabetes. Like other drugs in the Thiazolidinedione class, the Diabetic Drug Avandia functions by acting on the patients insulin resistance, and also appears to have some anti-inflammatory effects. Patients should not take Avandia if they have type 1 diabetes.

As with any prescription medication, patients who take Avandia have reported a number of common side effects, including: cough or cold, headache, inflammation of the sinus, back pain, and swelling or fluid retention. Beside these more common side effects, Avandia has been linked to more serious afflictions in some patients, including a negative impact on liver functionality, which has caused the FDA to issue warnings against the diabetes medication being prescribed to patients with pre-existing liver conditions. The drug can also lead to hypoglycemia, which means that patients who have been diagnosed with any variety of hypoglycemic condition should not be prescribed Avandia.

While the risk of these side-effects have been long understood, a recent study published in the New England Journal of Medicine in the June 14, 2007 issue claimed that Avandia medication may increase the risk of serious heart attack in patients by 43 percent. The scale of this increased risk has caused serious concern among those type 2 diabetes patients that take Avandia to manage their diabetes on a daily basis.

The release of the study's findings has also prompted the FDA to release an alert as of May 21, 2007, which states that they are aware of the possible implications the study poses and are evaluating all of the available data in order to make a determination on whether doctors should continue prescribing Avandia to patients with type 2 diabetes. The FDA's warning does not however constitute an Avandia recall, as the FDA's warning goes so far as to the say that a direct causal relationship has not been proven to exist between Avandia and cardiac events that may result in death, given that there are studies with contradictory evidence.

However, the FDA does state that any patient with a heart condition or any underlying heart disease should seriously consult their doctor about the new information and the possible risk it could pose. As such, any patient taking medication such as Norvasc for Primary Pulmonary Hypertension (PPH) or any other medication related to a heart condition should seriously consider the implications of also taking Avandia, and consult with their doctor.

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