GlaxoSmithKline (GSK) has issued a statement in response to the FDA’s Early Communication about the safety review of orlistat.
The company said that the FDA is reviewing data from suspected cases on liver injury associated with the use of orlistat/alli. Any routine assessment from a regulatory body does not mean that a risk or causal relationship exists.
According to the company, alli is a non-systemically acting medicine. It is minimally absorbed in the blood and works locally in the gastro-intestinal tract. There is therefore no obvious biological mechanism to suggest liver damage can occur with alli.
As per the statement: GSK stands firmly behind the safety and efficacy of alli. Our primary priority is patient health, and we want people to know that there is no evidence that alli causes liver damage. Liver changes can have many causes. People who are overweight and obese are predisposed to liver-related disorders. GSK regularly communicates with independent regulatory bodies and provides them with comprehensive safety data on our products. Orlistat, the active ingredient in alli, is the most-studied weight loss medicine, with safety established through 100 clinical studies involving more than 30 thousand patients.