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Manufacturers of Type 2 Diabetes Prescription Drug Receive FDA Warning

By Alan Haburchak

Republish: EasyPublish™ Published: 09May2008 Word count: 556 Viewed: 372 time(s) Get Free Content For Your Site

GlaxoSmithKline, makers of the type 2 diabetes prescription drug known as Avandia, recently received warnings from the U.S. Food and Drug Administration (FDA) after the company withheld post-marketing research information on Avandia.

Avandia, also known as its generic name rosiglitazone maleate, is an oral medication used to control an individual's blood sugar level as well as continue to regulate sugar levels. Avandia was once reportedly the best-selling diabetic drug around the world, however, a study published in the New England Journal of Medicine reported results from clinical trials of the drug, which found Avandia to have severe side effects on individuals both with a history of heart disease and without.

The report, released in May 2007, found that patients were more likely to suffer from heart disease after taking Avandia for a period of time and individuals with a history of heart disease were likely to suffer a worse outcome, as the drug increased the ill-effects of heart disease among patients and resulted in death from cardiovascular-related causes. In fact, the study found a 43 percent increased risk of myocardial infarction, otherwise known as a heart attack. Both regulators in the United States and in Europe increased warning labels of Avandia's prescribing information as a result of the May 2007 report and sales have dropped by nearly half, according to news reports.

The warning letter from the FDA came after GlaxoSmithKline failed to meet their deadline for reporting the results and research of 10 ongoing clinical trials of Avandia. Federal regulations require that the companies provide FDA officials with updates of the after-market studies. The Avandia studies were over a six-year period ranging from 2001 to 2007. In November 2007 the FDA completed a routine inspection of the company and drug. Officials found that information from the trials was not adequately presented and information remained missing.

GlaxoSmithKline responded by stating that the information that was withheld from FDA officials had nothing to do with the potential safety risks of the drug and since the FDA inspection, the company has claimed that new training methods and programs have been implemented to avoid the loss of data reported to the FDA.

Avandia was approved for market in May 1999 and has been used as a potential drug to benefit Alzheimer's disease as well as to treat type 2 diabetes. Currently, there are approximately 3.5 million individuals taking Avandia, although, that number has likely decreased with the continuation of negative reports surrounding the drug. In addition to the risk of heart disease, Avandia has been associated with other serious side effects including an increased risk of osteoporosis and bone fractures among patients. Researchers from the Salk Institute for Biological Studies have found that Avandia disrupts the natural process of osteoblasts and osteoclasts, the two types of cells in the body the work to renew old bone growth with new, strong and healthy bone; although clinical trials are ongoing.

Other common side effects of the drug include headache, inflammation of sinuses, weight gain, back pain, swelling or fluid retention. Individuals who have taken Avandia and been victim to the serious side effects of the drug should speak with an experienced pharmaceutical attorney, as the potential for an Avandia lawsuit exists and may result in monetary compensation for the damage done to an individual's health.

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