Glaxo Wellcome Suspends Troglitazone Availability

Glaxo Wellcome says it has voluntarily suspended the availability in theUK of Romozin (troglitazone), the insulin sensitizer for type II diabetes, after only two months on the market, amid reports of a sharp rise in the number of patients with severe hepatic adverse events.

Perhaps surprisingly, shares in GW jumped 40 pence to close at L13.40 ($22.59) on the day of the announcement. The news did not appear to hit Sankyo, which developed the drug and markets it in Asia under the brandname Noscal, too hard either; the company saw only 40 yen ($0.31) fall off its stock, to close at 4,050 yen. In contrast, the move caused shares in Warner-Lambert (which markets the drug as Rezulin in the USA) to fall $26.50, closing at $113.38. Analysts talking to the Wall Street Journal said that W-L had more at stake commercially - with a potential revenue double what it would have been in Europe.

Earlier this year, the US Food and Drug Administration and W-L sent out "Dear Doctor" letters advising physicians that liver enzyme levels be checked during the first one to two months of troglitazone therapy, and every three months for the first year and periodically thereafter (Marketletter November 10). This move came in response to 35 post-marketing reports of liver injury in patients taking troglitazone, ranging from elevated liver transaminase levels to liver failure and liver transplant and one death (as of October 21).