Document nN19qXQxwYro7m0Rx6rXoxK11

SmartMoney Breaking News Published September 13, 2010 10:01 AM FDA Mulls Removing Diet Drug From U.S. Market By Jennifer Corbett Dooren Of DOW JONES NEWSWIRES WASHINGTON -(Dow Jones)- A federal advisory panel is being asked to help decide whether Abbott Laboratories' (ABT) weight-loss drug Meridia should stay on the market. Meridia has been the subject of an on-going safety review. Earlier this year the European Medicines Agency ordered Abbott to remove Meridia from the European market and the FDA toughened warnings on the drugs' label saying it shouldn't be used in patients with a history of heart problems. At the time, the FDA also said the product should be discontinued in patients who do not lose at least 5% of their baseline body weight within the first three to six months of treatment. Now the FDA is considering whether to remove the product from the U.S. market. Meridia will be discussed Wednesday by the agency's endocrinologic and metabolic drugs advisory committee, which is made up of non-FDA medical experts. The panel is being asked to vote on what additional regulatory action it thinks the FDA should take, including whether the product should be withdrawn from the U.S. market. The FDA usually follows the advice of its advisory committee but isn't required to do so. The FDA posted background materials for Wednesday's meeting on its website Monday. The panel will primarily discuss a clinical study known as Scout, which was conducted in patients with a history of heart disease or diabetes. It showed patients in the study had a higher rate of cardiovascular events compared to patients on a placebo medication. An FDA clinical review of the study said, "in a population of middle-age and older overweight and obese subjects, treatment with [Meridia] for an average of 3.5 years increased the relative risk for major adverse cardiac events by 16%." However, the FDA said the data from the study haven't been fully analyzed. According to another FDA memo, agency staff said there was evidence while that Meridia improved some cardiac risk factors but that it "may have a detrimental effect on others," such as an increase in blood pressure and heart rate. Still, the memo said, given the modest decrease in body weight seen with most patients taking Meridia, "even a small increase in cardiovascular risk seems unwarranted." In a document also posted to the FDA's web site, Abbott said use of Meridia in the target population currently described on the product's label is associated with a low rate of cardiovascular events. The company said it supports placing a boxed warning on the product giving doctors "advice on monitoring and discontinuation of therapy based on blood pressure, pulse, and weight loss parameters." A boxed warning is FDA's toughest warning on a drug label. -By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com (END) Dow Jones Newswires 09-13-10 1001ET URL for this article: http://www.smartmoney.com/breaking-news/on/?story=ON-20100913-000204 SmartMoney Mobile | Customer Service | Magazine Customer Service | Subscribe to SmartMoney Magazine | Your Profile | Careers | Contact Us Reprints | About Our Ads | Custom Publishing | License Our Content | Media Kit | Press Room | Events | Site Map | Labs | SMARTMONEY , smSmallBiz TM, SmartMoney.com TM, and smSmallBiz.com TM are trademarks and service marks of Dow Jones & Company, Inc. The layout and "look and feel" of the smartmoney.com and smSmallbiz.com web sites are copyrighted materials of Dow Jones & Company, Inc. 2010 Dow Jones & Company, Inc. All Rights Reserved. By accessing and using this page, you agree to ouPrrivacy Policy and Terms of Use. All quotes delayed by 15 minutes. Delayed quotes provided by Interactive Data Real-Time Services, Inc.. Historical prices and fundamental data provided by Morningstar, Inc. Mutual fund data provided by Lipper. Mutual Fund NAVs are as of previous day's close. Earnings estimates provided by Zacks Investment Research. Insider trading data provided by Thomson Reuters. Upgrades and downgrades provided by Briefing.com. You Are Viewing: SmartMoney.com -- Investing, Saving and Personal Finance.