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. Orlistat is minimally absorbed in the blood and works locally in the gastro-intestinal tract. GSK continues to proactively monitor for the safety of orlistat and share all relevant information with regulatory agencies.
Since orlistat first became available as a prescription medicine in 1998, more than 40 million people have used the drug. Of these, more than 10 million have used alli, the only FDA-approved over-the-counter weight loss product.
Orlistat, the active ingredient in alli, is the most-studied weight loss medicine. Its safety has been established through 100 clinical studies involving more than 30 thousand patients.
People using alli should talk to their doctors or pharmacist if they have any concerns.