FDA Panel Approves OTC Orlistat

FDA Panel Approves OTC Orlistat
Published Online: Saturday, April 1, 2006

GlaxoSmithKline Consumer Healthcare received approval from an FDA advisory panel to sell the fat-blocking pill orlistat over the counter. If approved by the agency, it would be the first OTC diet pill okayed by the FDA. Roche currently sells the prescription form of orlistat (Xenical) and will continue to do so; the OTC version would be a half dose. In 6-month clinical trials, orlistat produced an average weight loss of 5.3 to 6.2 lb more than placebo. Once a patient stops taking orlistat, its effects stop as well. Although GlaxoSmithKline officials recommend that people use it for only 6 months at a time, as an OTC drug its length of use by patients would not be monitored. Because the weight loss achieved by orlistat is considered "modest," it should be used in conjunction with diet and exercise. GlaxoSmithKline is planning to market the drug under the name "Alli," at a cost to consumers of $12 to $25 a week. Orlistat works by blocking the absorption of about one quarter of any fat consumed, which is about 150 to 200 calories. That blocked fat would be passed in stools, which may be oily or loose. Other side effects include gas, incontinence, and oily spotting; more extreme side effects are hepatitis, kidney stones, and gallstones. Despite what the manufacturer considers to be a "very low" potential for abuse, there is concern that people will not understand the labeling instructions that state that users should take supplemental vitamins before and after taking orlistat.

Ms. Farley is a freelance medical writer based in Wakefield, RI.




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