A new drug for diabetes, troglitazone (Romozin), has been declared unsafe and banned in Britain. The decision has come after six people died and numerous liver injury cases were reported worldwide.
Over 150 people have suffered reactions from troglitazone, out of the three hundred thousand patients worldwide who have been treated with the drug since its launch in October 1997. Reactions to the drug have ranged from severe liver damage to liver necrosis (cell death) and liver failure.
Glaxo Wellcome, the company which markets the drug in this country, and the Medicines Control Agency believe that since the harmful effects and the risks cannot be predicted accurately, the drug would not be safe for some patients, particulary those with the type of diabetes known as type 2.
Troglitazone is still available in the United States because the Food and Drug Administration (FDA) said that the benefits outweighed the risks – as long as patients receiving the drug are continuously monitored for signs of liver injury. The FDA has also suggested that a label should prominently display a warning of the drug’s harmful side effects.
G1axoWellcome has now withdrawn its application to market troglitazone across Europe (BMJ,1997; 315:1564).