May 22, 2007 in Nation/World

Study shows diabetes drug may increase heart risk

Rob Stein Washington Post
 

At a glance

Avandia

“Avandia was approved in 1999 for patients suffering from type 2 diabetes, which affects 20 million people and causes blood sugar to rise to dangerous levels.

“The drug helps control levels by increasing the effectiveness of insulin produced by the body.

“About 1 million Americans take the drug.

WASHINGTON – A drug widely used to control diabetes increases the risk of heart attacks and possibly death, researchers reported Monday, raising alarm about another popular prescription medication.

The drug, Avandia, taken by about 1 million Americans to keep their blood sugars at safe levels, boosts the risk for heart attacks by 43 percent and may increase the risk of dying from such an attack or stroke by 64 percent, according to a new analysis.

“This is very concerning,” said Steven Nissen of the Cleveland Clinic, who conducted the analysis released early by the New England Journal of Medicine because of its public health implications. “When you have a drug widely used in a population with a high inherent rate of heart disease, it’s very, very concerning.”

Nissen and others advised patients taking the drug to immediately consult with their doctors about whether they should switch to another medication.

“I don’t see a rationale for using this drug,” said Bruce M. Psaty of the University of Washington, who co-wrote an editorial accompanying the study. “The purpose of taking this drug is to prevent a heart attack, and this indicates it actually increases the risk.”

Manufacturer GlaxoSmithKline defended Avandia’s safety, saying the analysis had fundamental limitations and other large, more reliable studies have found no evidence of increased risk.

“We are confident in the benefit-risk profile for Avandia,” said Ronald Krall, the company’s chief medical officer. “It is an important treatment for patients with type 2 diabetes.”

Nevertheless, the report prompted calls for the Food and Drug Administration to take some kind of action, either by issuing warnings about the drug’s safety or possibly pulling it from the market.

“Unless the FDA has some kind of data that provides a different picture, then some sort of action is warranted,” Psaty said. “I just don’t see a reason to have this drug on the market.”

The findings prompted new calls to overhaul the drug safety system, which has come under intense criticism after a series of revelations about the dangers of widely used drugs, most notably the arthritis drug Vioxx.

“Here we have yet another example of a very commonly used drug taken by millions and millions of patients that has important safety concerns that the FDA has missed for years and years and years,” said Jerome Avorn of Harvard Medical School. “How many of these do we really need to happen before we step back and do something?”

Congress is considering legislation that would give the FDA new powers to monitor drug safety.

The full paper will be published in the June 14 issue of the journal.


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