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Meridia Study Shows Increased Risk for Health Events in Some
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Atlanta, GA: Results from a study of the weight-loss drug Meridia show a connection between increased risk for heart attack and stroke in patients with a history of heart attack and stroke who were followed for roughly 3.5 years while taking the drug.
The SCOUT study, reported in the New England Journal of Medicine the first week of September, 2010, confirms longstanding concerns about the safety of Meridia when taken by people with heart disease and other heart-related health problems.
The federal Food and Drug Administration (FDA) has assembled an advisory committee that will meet later in September to discuss increasing the regulation for the drug. The FDA's action was prompted by initial data from SCOUT, which were released in November 2009.
The study followed 10,744 overweight and obese patients with a history of heart disease or type 3 diabetes and one additional risk factor for heart disease during the nearly four year follow-up period. The results show that during the follow-up, there was a 4.1 percent incidence of nonfatal heart attack and a 2.6 percent incidence of stroke among patients receiving Meridia. That translates into a 28 percent increased risk of heart attack and a 36 percent increased risk of stroke. No increased incidence of heart attack or stroke was evident in people with diabetes but no history of those health issues.
In a report by CNN.com, the study's lead researcher, W. Philip T. James, MD, who is an obesity expert at the London School of Hygiene and Tropical Medicine in the UK, said that the study emphasizes the fact that Meridia should not be prescribed to people with existing heart problems.
Approved by the FDA in 1997, Meridia carries a warning stating that the drug should not be used by people with a history of heart disease, heart failure, heart-rhythm problems or stroke. However, after reviewing the initial data from SCOUT, the FDA asked Abbott , the maker of the drug, to strengthen the warning. And within the European Union, the European Medicines Agency -- the European equivalent of the FDA -- suspended sales of the drug.
SEP-02-10: Study: Weight-loss drug ups risk of heart attack, stroke in some. CNN: HEALTH.COM
Published on Sep-2-10
The SCOUT study, reported in the New England Journal of Medicine the first week of September, 2010, confirms longstanding concerns about the safety of Meridia when taken by people with heart disease and other heart-related health problems.
The federal Food and Drug Administration (FDA) has assembled an advisory committee that will meet later in September to discuss increasing the regulation for the drug. The FDA's action was prompted by initial data from SCOUT, which were released in November 2009.
The study followed 10,744 overweight and obese patients with a history of heart disease or type 3 diabetes and one additional risk factor for heart disease during the nearly four year follow-up period. The results show that during the follow-up, there was a 4.1 percent incidence of nonfatal heart attack and a 2.6 percent incidence of stroke among patients receiving Meridia. That translates into a 28 percent increased risk of heart attack and a 36 percent increased risk of stroke. No increased incidence of heart attack or stroke was evident in people with diabetes but no history of those health issues.
In a report by CNN.com, the study's lead researcher, W. Philip T. James, MD, who is an obesity expert at the London School of Hygiene and Tropical Medicine in the UK, said that the study emphasizes the fact that Meridia should not be prescribed to people with existing heart problems.
Approved by the FDA in 1997, Meridia carries a warning stating that the drug should not be used by people with a history of heart disease, heart failure, heart-rhythm problems or stroke. However, after reviewing the initial data from SCOUT, the FDA asked Abbott , the maker of the drug, to strengthen the warning. And within the European Union, the European Medicines Agency -- the European equivalent of the FDA -- suspended sales of the drug.
SEP-02-10: Study: Weight-loss drug ups risk of heart attack, stroke in some. CNN: HEALTH.COM
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