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12-Oct-10 4:00 PM  CST  

Abbott Labs Withdraws Meridia 

Abbott Laboratories has decided to remove diet drug Meridia (sibutramine) from the market, the company announced last week.
 
Abbott made the decision at the request of the FDA after results of the SCOUT (Sibutramine Cardiovascular OUTcome Trial) post-market clinical trial revealed that participants who took Meridia had a 16 percent higher risk of heart attack and stroke compared with participants who took a placebo.

SCOUT was originally done at the request of the Committee for Medicinal Products for Human Use under the European Medicines Agency, which pulled Meridia off the European market in January. The results of the trial, released in November last year, generated controversy when it was found that some trial participants had a history of cardiovascular problems. Meridia was contraindicated in patients who had a history of coronary artery disease, congestive heart failure, heart attack and stroke, according to a labeling revision done in 2004, due to the fact that Meridia could raise blood pressure in certain patients.

“The analysis of (SCOUT) is ongoing and FDA is making no conclusions about the preliminary findings at this time. These findings highlight the importance of avoiding the use of sibutramine in patients with a history of coronary artery disease (heart disease), congestive heart failure (CHF), arrhythmias, or stroke, as recommended in the current sibutramine labeling,” the FDA said in a statement released about Meridia back in November last year after the results of SCOUT were released.  

The controversy prompted the FDA to conduct a thorough review to decide if it was warranted to keep the drug on the market. When an advisory panel finally voted in September on whether or not to remove Meridia, the panel’s decision was split at 8-8. Ultimately, the FDA released recommendations against continued use of Merida, and the agency requested that Abbott pull the drug off the market.

“Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke,” said John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER), in a statement released by the FDA.

Meridia was originally approved by the FDA in 1997 for weight loss in people suffering from obesity or in overweight people who had other risks for cardiovascular disease. The removal of Meridia from the market leaves orlistat, sold under the trade names Xenical (by Roche) and Alli (by GlaxoSmithKline), as the only medication approved specifically for weight loss left available in the United States.

Patients currently using Meridia should discuss alternative weight loss products and programs with their primary care physician and their pharmacist. Abbott has also made available an information hotline for patients who have questions about Meridia’s withdrawal. The phone numbers and more information are available at www.sibutramine.com.
 

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Source: NPTANews

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Tags: Abbott clinical trial cpht diet drugs European Medicines Agency FDA Labs market withdrawal Meridia npta obesity obesity medications pharmacy pharmacy technician SCOUT sibutramine study weight loss

 

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