Italy Suspends Sales of Reductil (Meridia) Following Two Deaths

The Italian Ministry of Health has suspended sales of the weight-loss drug Reductil (sibutramine) following the deaths of two women, but no similar action has been taken by any other country.

The drug is sold in the United States under the brand-name Meridia, and was approved by the Food and Drug Administration in 1997.

Abbott, manufacturer of the drug, said the two patients "had other serious medical conditions and had been taking other medications" and that it is "unlikely that these deaths are related to the drug."

"Abbott has continued to routinely monitor the safety profile of Reductil and provide semi-annual safety updates to regulatory authorities throughout Europe," said Margo Heath-Chiozzi. "Based on these reports, there has been no substantial change to the risk/benefit profile of the drug."

The two women who died were aged 28 and 45, and the deaths were "apparently related to cardiovascular-related causes," according to FDA spokeswoman Laura Bradbard.

"The labeling of Meridia mentions high blood pressure as a risk factor and they should not be taking Meridia if they have a high blood pressure problem," she said. "Patients who are overweight and obese are at risk for high blood pressure, high cholesterol and diabetes. These factors can lead to an increased risk of heart attack and stroke."

Heath-Chiozzi said that since it was first approved, more than 8.5 million people in more than 70 countries have used sibutramine for the management of obesity.

Other sources: Chicago Tribune, Abbott