Records reveal Galxo’s Avandia is a potential killer

Records reveal Galxo’s Avandia is a potential killerA special hearing by the US regulators could decide the fate of the once popular drug of Glaxo, Avandia which was claimed to change the lives of people who suffer from diabetes being accused as a potential killer now.

After six years of bitter debate about its safety, the Food and Drug Administration (FDA) will convene a two-day hearing tomorrow ] at a hotel in suburban Washington to scrutinise some 700 pages of research on whether the treatment poses an enhanced risk of heart attacks. The FDA's committee could recommend a tougher warning label, tighter restrictions on prescriptions or could call for the drug to be withdrawn from the US market.

The Food and Drug Administration (FDA) has called for hearing tomorrow to review the research work on the claim that usage of Avandia increases the risk of heart attacks. After the hearing the FDA could propose more restrictions on the prescriptions or display higher warning on the label or might advise for the drug to be removed from the US market.

After a cardiologist attached to the Cleveland Clinic claimed in his study in 2007 that the usage of Avandia could result in the increase of heart attacks occurrence by 43 per cent, the sales of the drug has come down by half to £771m in 2007 from £1.4bn in 2006 inspite of Glaxo trying to prove that it is safe through various studies.

Murray Stewart, Glaxo's vice-president for clinical development said that the results of six clinical trials conducted in a controlled way to observe the effect of Avandia on heart since 2007 shows that the drug does not aggravate the risk of heart attack, stroke or death.

The pharmaceutical industry is witnessing one of its strongest fights in the recent past in the row over Avandia.

Glaxo asserts that Record, a study on a bigger scale with 4,447 patients from 23 countries participating concluded that the drug was safe. But one of the FDA reviewer challenged that the study had overlooked some of the serious heart attacks while another reviewer had questioned his argument.