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Meridia Label Changes Announced

Jan 21, 2010 | Parker Waichman LLP

The U.S. Food & Drug Administration (FDA) today informed healthcare professionals that it had requested and Abbot Laboratories has agreed to add a new contraindication to the label of the weight loss drug, Meridia. The contraindication will state that Meridia is not to be used in patients with a history of cardiovascular disease, including:

• History of coronary artery disease (e.g., heart attack, angina)
• History of stroke or transient ischemic attack (TIA)
• History of heart arrhythmias
• History of congestive heart failure
• History of peripheral arterial disease
• Uncontrolled hypertension (e.g., > 145/90 mmHg)

In November, the FDA said that preliminary data from a study called Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT) suggested that patients using Meridia experienced a higher number of cardiovascular events compared to those using a placebo. SCOUT, which began in 2002, involved approximately 10,000 patients who were 55 years of age or older, overweight or obese, and had a history of heart disease or type 2 diabetes plus one additional cardiovascular risk factor. Patients who recently had a heart attack or stroke, or had poorly controlled congestive heart failure were not included in the study.

Additional data from the SCOUT study reviewed by the  FDA indicate that the increased risk for cardiovascular events with Meridia occurred only in patients with a history of cardiovascular disease.

The FDA said patients currently using Meridia should talk with their healthcare professional to determine if continued use of the drug is appropriate and discuss any questions they may have about their treatment.

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