The FDA voted to keep drug maker GSK’s flagship product Avandia (Rosiglitazone) can stay on the market with tougher warnings.  Questions regarding the safety of GlaxoSmithKline’s blockbuster drug started after an article published in the New England Journal of Medicine showed Avandia increased the risk of heart attack.
Avandia has been on the market for 11 years. The drug is widely used in US to control type 2 diabetes.  Avandia falls under the class of thiazolidinedione drugs and works by binding to specific receptors, PPAR in fat cells and making them more responsive to Insulin. GSK sells Avandia alone and in combination with metformin or glimepiride.
The controversy surrounding Avandia started in 2007 when FDA and European Medical Agencies flagged the drug for increased risk of heart attack, strokes and deaths in older adults. Despite many clinical trials to evaluate the cardiac safety of the drug the safety of Avandia is still in doubt.  Many researchers feel that this drug causes more deaths than Pioglitazone (Actos) and hence should be taken off from the market.
FDA panel reviewed an exhaustive 700 page document and voted 21 – 12 for keeping the drug in the market, but with change in drug label and associated warnings. Experts have insisted that patients should be educated by physicians about the risks & safety of Avandia. FDA group itself is widely divided on the case of Avandia and its potential health risk on patients. The agencies have decided to re-examine the product due to latest possibility and pressure from Captol Hill. There has also been a question on companies trust worthiness – as it is believed that the company officials had deliberately hid the safety data of the drug from FDA during drug approval process.
The European Medical Agencies planned for a review on market authorization of Avandia from July 19 to July 22. European ministry of Health and agency have formed a committee, Medical product for Human use who would be responsible to review the case of this drug. It is strongly believed that once FDA has made a decision on this drug, regulatory bodies & health authorities from other countries will also follow the same line.
Officials from GSK are confident on the drug and for the safety of the patients. They have always expressed that Avandia is an important treatment option for Type 2 diabetes patients. On the recent controversies, company officials have always worked with the respective Health authorities and medical agencies like European Medical Agencies and FDA for the best interest of the chronic disease and safety of the patients.
Market share and the prescription rate, both, for Avandia has decreased since 2007. GSK is also facing strong market competition for its diabetes portfolio. Post controversy, study revealed that this drug may induce adverse events like some damages in the eye, bone loss, and heart problems. Studies also indicated that Avandia does increase the risk of heart attack – up to 20 to 25 percent. But in the past, drugs have been withdrawn from the market having risk up to 200 – 300 percent.
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