From: Reuters
Published November 27, 2007 10:23 AM

CORRECTED: Experts urge more cautious use of diabetes drugs

(Corrects spelling of "thiazolidedione" and "thiazolidediones" to "thiazolidinedione" and "thiazolidinediones" throughout, respectively.)

LONDON (Reuters) - European and U.S. diabetologists called on Tuesday for greater caution in prescribing oral diabetes pills like GlaxoSmithKline Plc's Avandia, which has been linked to increased heart attack risk.

Glaxo's Avandia has lost ground to Takeda Pharmaceutical Co Ltd's Actos in recent months, following publication of a U.S. study in May criticizing its safety record. Both drugs belong to a class of medicines known as thiazolidinediones.

In the light of the latest findings, the European Association for the Study of Diabetes and the American Diabetes Association said they had updated their "consensus statement" on use of oral anti-diabetics in patients with type 2 diabetes.

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"New information suggests additional hazards associated with the use of either thiazolidinedione, and rosiglitazone (Avandia) in particular may result in an increased frequency of myocardial infarctions," the revised statement concludes.

"We therefore recommend greater caution in using thiazolidediones, especially in patients at risk of, or with, congestive heart failure."

The updated statement, detailing when to use the drugs, was published online in Diabetologia and Diabetes Care (http://www.easd.org/Customfiles/easd/press/thiazolidinediones.p df).

The move comes two weeks after the U.S. Food and Drug Administration said Avandia should carry a new "black box" warning that it may cause chest pain or heart attacks.

Glaxo will also start a trial comparing Avandia head to head with Actos to see if the risk is unique to Avandia.

Avandia and Actos both already carry strong warnings advising of the risk of heart failure, a chronic condition that affects the heart's ability to pump blood.

Avandia was Glaxo's second-biggest drug in 2006, with sales of 1.6 billion pounds ($3.3 billion), but sales have plunged since May, with revenues in the United States down 48 percent in the three months to September 30 from the year-ago period.

(Reporting by Ben Hirschler; Editing by Rory Channing)

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