Avandia or rosiglitazone is an oral diabetes drug approved to treat type 2 diabetes. The disease is thought to affect 18 to 20 million Americans at this time. Type 2 diabetes is one of the so-called lifestyle diseases. Complications include coronary heart disease, blindness, kidney failure and limb amputation

Avandia won approval from the FDA in 1999 to treat people suffering from type 2 diabetes. The approval was based on clinical trials, which showed the drug was very useful in reducing blood sugar levels in people suffering from the condition.

In May the FDA issued a safety alert on Avandia following the publication of an article questioning the drug's safety profile. The study was posted on the web site of the New England Journal of Medicine ahead of print on June 14. It said Avandia had the potential to increase a person's risk of heart attacks and even death.

The study was conducted by Dr. Steven Nissen and Kathy Wolski at the Cleveland Clinic. They reviewed 42 previous studies on Avandia involving 28,000 patients. Among them 15,560 were taking Avandia, while the rest were on placebo.

The researchers said 86 people taking Avandia had heart attacks compared with 72 people taking a placebo. Furthermore some 39 people taking the drug died from heart complications, while 22 patients not receiving the drug also died from cardiovascular causes.

The FDA received the data from Glaxo on the heart risk of Avandia in August 2006. The agency decided to issue a safety alert following the early release of the NEJM study.

Dr. Robert J. Meyer, director of FDA's Office of Drug Evaluation II, said the data in the study was inconclusive and hence the FDA did not feel the need to take any action. Following the NEJM study, the FDA advised Avandia users to consult their doctors before continuing the drug.

Over 2 million people worldwide use Avandia to control their blood sugar levels. The drug manufactured by GlaxoSmithKline has an annual sales turnover of $3.2 billion. In such a scenario, the new study questioned if the drug should even be prescribed to diabetics at all.

Experts said that Avandia had no obvious benefits over other diabetes drugs available on the market. In the wake of the new study they recommended that type 2 diabetes sufferers move to other available drugs.

The Food and Drug Administration review expressed concern over the potential to increase heart risks in patients and queried if new warnings were needed on Avandia.

"A critical question to be resolved in determining appropriate regulatory action is whether the anticipated therapeutic benefit of rosiglitazone outweighs the demonstrated cardiovascular risk," one agency reviewer revealed.

GlaxoSmithKline though is engaged in a massive PR exercise aimed at rescuing its star drug from the quagmire it finds itself in. Glaxo's problem is compounded by the fact that Takeda's Actos is very similar to its Avandia and patients could easily migrate to Actos.

Monday could not only decide the fate of Avandia, it could also boost Actos' chances in the lucrative diabetes drugs market.

For diabetes sufferers though the path ahead is clear. Talk to your doctor before taking any chances. If you have pre-existing heart conditions, it is better to shift to other drugs.

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