On December 1, 1997 the U.S. FDA (Food and Drug Administration), expressed safety concerns about a promising diabetes drug (Rezulin), that had been withdrawn from the British marketplace. The FDA recommended stricter monitoring be required of U.S. patients taking the company's drug because of liver problems found in a small number of users. Rezulin, taken as a tablet, lowers blood glucose levels in-patients thought to be resistant to insulin, the traditional treatment for diabetes.

The company said it planned to insert a highly visible warning label on the drug's packaging, although it said the liver function problems associated with Rezulin were only in an "extremely rare" group of patients.

Glaxo Wellcome, which markets the drug in Britain under the name Romozin, suspended its sales there pending a review. Glaxo also withdrew applications to sell the drug in other European countries. Warner-Lambert said it did not agree with the decision by Glaxo, which did not consult the American company about withdrawing the drug from British pharmacies.

The FDA tightened its recommendations about the drug, known generically as troglitazone, after reports that some people using it had suffered liver failure and three died. The regulatory agency also said information about possible liver damage should be more prominently displayed on the label of the drug, which is made by Parke-Davis, a unit of Warner-Lambert.

Edmund Debler, an stock analyst at Mehta and Isaly, said the developments, particularly Glaxo's cautious response have cast doubts on troglitazone, even though relatively few patients had been shown to have suffered liver problems. It's definitely not good new for Warner-Lambert," he said, predicting the company might have to follow Glass's lead and withdraw the drug.

Rezulin, launched in March for treatment of Type II or adult onset diabetes, had sales of $130 million US in the third quarter of 1997.

Parke-Davis said that about 600,000 patients have taken the therapy in the US and an additional 200,000 in Japan, where it was developed by Sankyo Co. Ltd. Warner-Lambert said liver abnormalities had been seen in about 35 cases.