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    Industry Responds

    “Patient safety is of the utmost importance to Roche, and we regularly monitor the safety profile of all our medicines and provide this information to the FDA,” Roche spokesman Christopher Vancheri says in a written response. “Roche has not yet had the opportunity to thoroughly review the Public Citizen petition and therefore, cannot make any further comments.”

    He adds that “the efficacy and safety profile of Xenical is based on more than 10 years of clinical experience, and more than 38.7 million patients worldwide have received Xenical since it was first introduced to the market in 1998. The efficacy and safety of orlistat is based on more than 14,000 patients assessed in clinical studies."

    Deborah G. Bolding, communications manager-North America for GlaxoSmithKline, says “GlaxoSmithKline (GSK) is committed to ensuring that consumers and physicians understand the safety profile of orlistat and Alli.

    "Alli is safe and effective when used as directed," Bolding says. "Orlistat is minimally absorbed in the blood and works locally in the gastrointestinal tract. GSK continues to proactively monitor for the safety of orlistat and share all relevant information with regulatory agencies.”

    People using Alli should talk to their doctors or pharmacist if they have any concerns.

    Jury Still Out on the Safety and Efficacy of Alli, Xenical

    Louis Aronne, MD, founder and director of the Comprehensive Weight Control Program at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York City, is reserving his judgment on the benefits and risk of these drugs.

    “The leading cause of the need for liver transplant is becoming obesity,” he says. “We can’t really say that the drug is causing liver damage if people who are obese are taking it.”

    “Based on the large numbers of people who have taken these drugs, the chance seems very small of having any kind of complication,” Aronne says. “There is a benefit if someone is losing weight and maintaining that loss on these medications.”

    His advice is to get evaluated by your physician if you are taking these drugs and have concerns about your risk of side effects.

    Jeff Stier, a senior fellow at the Washington, D.C.-based National Center for Public Policy Research, follows health and science issues and agrees that the number of incidents reported compared to the overall number of doses taken over many years is “extremely low.”

    This medicine is not a magic bullet for obesity, he says. “It only works in conjunction with proper diet and exercise, but it can give people the boost they need to achieve healthy goals.”

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