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The voices urging stronger restrictions or even an outright ban on the diet drug Meridia will have their hearing this week before an FDA advisory panel. The FDA panel will review a study that found an increased risk of heart problems for those patients taking the diet drug. The study also showed an average weight loss of 8.8 lbs (4 kilograms). The FDA has the final decision-making authority, but often follows the panel's advice.
The diet drug Meridia (chemical name sibutramine) is made by Abbott Laboratories and was was first approved in 1997, according to a report by Reuters. The panel will review a study on the drug called the "Scout Study." The Scout study considered results with Meridia from patients with pre-existing heart conditions and/or diabetes. The study seemed to indicate more heart attacks and strokes in subjects taking Meridia than those taking a placebo.
According to Reuters, one FDA staffer, on reviewing the information and evidence regarding the drug said in a memo, "even a small increase in cardiovascular risk seems unwarranted" since the weight loss on Meridia was fairly small and can be re-gained after the drug has been discontinued by the patient.
Abbott Labs, in a memo to the FDA, merely said the Scout trial backs Meridia's current warning against use in patients with heart issues. Safety questions remain if a patient using the drug has an undiagnosed heart condition.
In company documents, Abbott maintained the current data regarding the use of the diet drug Meridia "continues to support its effectiveness as a weight loss agent in an appropriate patient population."
The FDA advisory panel is scheduled to meet Wednesday, September 15.
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