FDA panel recommends the approval of weight loss drug Orlistat

• A Food and Drug Administration panel of doctors and scientists voted Monday to recommend that the regulatory agency approve over-the-counter sales of a weight-loss pill now sold only with a prescription.
• Xenical, a fat-blocking obesity drug, was recently voted on by the FDA.
• Xenical, a fat-blocking obesity drug, was recently voted on by the FDA.
• GlaxoSmithKline Consumer health care still needs final FDA approval before it can sell the non-prescription version of orlistat, a drug already marketed in prescription form as Xenical, to overweight adults as use as a weight-loss aid.
• The FDA approved the prescription version of the fat-blocking pill made by Roche in 1999.
• XENICAL STRONG RECOMMENDATION: A Food and Drug Administration advisory committee voted 11-3 Monday to recommend the approval of over-the-counter sales of a prescription weight-loss pill.
• NEXT STEP: A non-prescription version of GlaxoSmithKline's orlistat, a drug already marketed in prescription form as Xenical, still needs final FDA approval.
• NEW RULING: The FDA has never approved any non-prescription weight-loss drugs for sale.
• A joint FDA advisory committee voted 11-3 to recommend approval late Monday following a daylong hearing.
• The agency usually follows the recommendations of its outside panels of experts.
• In six-month clinical trials, obese people who took orlistat lost on average 5.3 pounds to 6.2 pounds more than did those who were given dummy pills.
• Glaxo wants people to use it for only six months at a time, but as an over-the-counter item, its use could not be policed.
• However, the pill's effect ends once its use is stopped, said Julie Golden, a medical officer in the FDA's division of metabolism and endocrinology products.
• A previous study showed a progressive weight gain in patients after they discontinued use of orlistat, Golden said.