Routine Inspection Prompts Fda Warning

The makers of the once popular type 2 diabetes drug Avandia received a U.S. Food and Drug Administration (FDA) warning following a routine inspection.

Rosiglitazone maleate is the generic name of Avandia, which is taken orally to control insulin levels in the body. The New England Journal of Medicine released Avandia study results that linked the drug to an increased risk of heart disease, since that time, the drug’s sales have decreased and it is no longer the best-selling diabetic drug, as news reports once stated.

According to the May 2007 report, Avandia patients had a severely increased risk of cardiovascular-related conditions and those risks increased the longer an individual was on the drug. In fact, the study found a 43 percent increased risk of myocardial infarction, otherwise known as a heart attack. After the May 2007 reports of Avandia increasing the risk of heart disease, the drug has seen a decline in sales and both regulators in the U.S. market and European market have increased warnings on the drug.

GlaxoSmithKline did not adequately meet the deadline set by the FDA in their reporting of Avandia clinical trials. The FDA’s regulations require that after-market results are given to FDA officials. 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. Presently, 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. Additionally, it was discovered that individuals taking Avandia have a slowed process of bone development, according to the Salk Institute for Biological Studies, which determined the disruption of osteoblasts and osteoclasts; however, clinical trials continue.

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.