More Warnings Added to Diet Drug Meridia
New warnings of possible cardiovascular problems in some patients have been added to Meridia, the diet drug studies have recently linked to serious heart complications.
The Food and Drug Administration said a review of study data showing increased risks of heart attack and stroke in Meridia users with a history of cardiovascular disease prompted the agency’s request for the drug’s maker to add a warning to the packaging. One prominent consumer rights group has called on the FDA to ban Meridia due to the risks of serious and deadly heart complications.
Meridia, known chemically as sibutramine and made by Abbott Laboratories Inc., was FDA approved in 1997 for treating obese patients. The prescription drug is used along with reduced-calorie diets in patients who have a body mass index (BMI) greater than 30 or a BMI of greater than 27 along with other risk factors, such as diabetes, high cholesterol, or high blood pressure, the FDA said.
Counter-Indications Added to Meridia
The drug already includes labeling warnings against using the drug in patients with cardiovascular disease. Now, at the request of the FDA, the drug will carry the following counter-indications:
• History of coronary artery disease (such as heart attack or angina)
• History of stroke or transient ischemic attack (TIA)
• History of heart arrhythmias (irregular heartbeats)
• History of congestive heart failure
• History of peripheral arterial disease
• Uncontrolled hypertension (higher than 145/90 mmHg)
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