FDA Flags 2 Dietary Supplements

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If you want to lose weight, you’re better off cutting calories than using a dietary supplement.

An FDA panel voted 9-5 against recommending the prescription diet drug Lorcaserin, citing both the drug’s minimal effectiveness and tests that showed tumor growth in rats.

In human trials, the drug was shown to reduce body weight by 5.8%, just more than the 5% threshold required to be considered effective. A final decision on Lorcaserin and another drug, Qnexa, is due in October, with both vying to be the first new prescription weight-loss drug in a decade. Qnexa was also not recommended by the panel due to health concerns, despite being far more effective in trials than Lorcaserin.

Shares of the drug’s manufacturer, Arena (Stock Quote: ARNA), plunged in after-hours trading upon news of the panel’s rejection.

Meanwhile, a dietary supplement for weight lifters is being voluntarily recalled after being linked to a laundry list of side effects, including decreased bone growth, reduced sperm count and aggressive behavior. Fizogen Precision Technologies is recalling Off Cycle II Hardcore, which is an over-the-counter supplement intended for use as a post anabolic cycle recovery agent. The product is marketed to those looking to build muscle mass. The FDA warns that Off Cycle II Hardcore includes aromatase inhibitors that “have a reasonable probability of resulting in permanent impairment of a body structure or function in at risk consumers.”

While Fizogen discontinued the supplement in July 2009, some online retailers are still selling it. Customers who have purchased the supplement are advised to return the unused portion to the retailer, and to call Fizogen at 1-(800)929-4099 with any questions.

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