GlaxoSmithKline's Avandia to be relabeled with new warnings in Europe

10/18/2007- GlaxoSmithKline PLC's Avandia diabetes medicine is to be relabeled with a stronger warning about heart attack risks after European authorities met to discuss all products in the diabetes class.

The new warning will be for patients who currently have ischemic heart disease or have had it in the past. The ruling means that doctors will need to make a more careful assessment before prescribing the drug to certain patient groups.

The ruling follows an earlier FDA decision to relabel Avandia in the US -- prescriptions have since fallen by up to 46 pct in the US. A final FDA decision on the Avandia label is pending.

GSK said the European ruling showed that the benefits of Avandia continued to outweigh the risks.

However, in its ruling the human medicines committee (CHMP) did not order a similar relabelling for rival Takeda product Actos.

Deutsche bank described the decision as 'negative for the product' because it might give Actos a competitive advantage. Although, Deutsche points out that the European market represents only 14 pct of worldwide sales and about 5 pct of GSK's value because of patent expiry in 2012.