GSK releases statement on safety of Alli

PITTSBURGH In light of raised safety concerns around orlistat, the active ingredient in the weight-loss drug Alli, GlaxoSmithKline on Tuesday stated: “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.”

The FDA is reviewing data from suspected cases on liver injury associated with the use of orlistat. Any routine assessment from a regulatory body does not mean that a risk or causal relationship exists, GSK stated. Orlistat’s safety has been established through 100 clinical studies involving more than 30,000 patients, the company added.

Orlistat 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 orlistat.

People who are overweight and obese are predisposed to liver-related disorders.