FDA's announcement it is investigating a possible risk of liver injury related to orlistat -- the active ingredient in Roche Pharmaceuticals' prescription weight-loss drug Xenical and GlaxoSmithKline's OTC alli –- could threaten future sales.
Despite FDA's encouragement that consumers and patients continue to use orlistat as directed, the announcement of the ongoing safety review could taint public perception of the drug.
The agency said in an Aug. 24 "early communication" letter that it received 32 reports of serious liver injury in patients taking orlistat –- between 1999, when it first approved Xenical (120 mg), and 2008. FDA approved alli (60 mg) in 2007.
Even though FDA emphasizes there is "no definite association between liver injury and orlistat," a spokeswoman said the agency announced the safety review now because "orlistat is a widely used drug, and we wanted to give consumers and health care professionals as much information as possible."
FDA first said on its Web site in June that it was evaluating "rare reports" of hepatitis and liver-related abnormalities in patients taking orlistat. The agency told "The Tan Sheet" at the time it was investigating the adverse events for a possible causal link.
Separately, FDA said in February that it was investigating reports of rectal bleeding linked to use of the drug.
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– Elizabeth Crawford (e.crawford@elsevier.com)
