July 15 (Reuters) - Valeant Pharmaceuticals InternationalInc's experimental drug to treat the skin disorderpsoriasis carries several potential risks that are challengingto assess due to limited controlled data, a preliminary reviewby the U.S. Food and Drug Administration.
The review comes two days ahead of a meeting of outsideexperts who will advise the FDA on whether the drug should beapproved. The agency is not obliged to follow the advice of itsadvisory panels but typically does so.
Some patients in clinical trials committed suicide and theagency said no risk management strategy will completelyeliminate the risk of suicide and suicidal thoughts seen withthe drug, broadalumab. (Reporting by Toni Clarke in Washington)