GlaxoSmithKline (GSK) said orlistat, an over the counter (OTC) drug under the trade name alli, is safe and effective when used as directed.
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Reportedly, orlistat’s safety has been established through 100 clinical studies involving more than 30,000 patients.
GSK said alli is the only FDA approved OTC weight loss product.
Orlistat works by inhibiting gastric and pancreatic lipases, the enzymes that break down triglycerides in the intestine.
When lipase activity is blocked, triglycerides from the diet are not hydrolyzed into absorbable free fatty acids, and are excreted undigested instead.
GSK said it will continue to proactively monitor the safety of orlistat and share all relevant information with regulatory agencies.
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