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# FDA Says FAAH Drugs in U.S. Development Safe After French Mishap
- URL: https://www.fdaweb.com/fda-says-faah-drugs-in-u-s-development-safe-after-french-mishap/
- Published: 2016-08-12T12:00:00.000Z
- Updated: 2026-09-14T21:24:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136498

FDA has completed a comprehensive review of safety information related to fatty acid amide hydrolase (FAAH) inhibitors under development in the U.S and determined that toxicity seen with a similar drug in France does not extend to others in the drug class. Earlier this year, the agency and European regulators began reviewing safety data after a Phase 1 trial, conducted by French clinical research organization Biotrial, resulted in the death of one enrolled patient and neurological injury to four others ([see earlier story](http://fdaweb.com/login.php?sa=v&aid=D5134527&searchWords=french&cate=S&stid=$1$4D/.5y4.$j7rH.zgjDA8hUOl5ryTiT/&ref=fdaweb.com)). The study involved Portuguese company Bial’s BIA 10-2474 and its use in neurological disorders.

  
“Based on these findings, the FDA is working with sponsors to establish the appropriate path forward for FAAH inhibitors under investigation in the U.S.,” an updated [safety notice](http://www.fda.gov/Drugs/DrugSafety/ucm482740.htm?ref=fdaweb.com) says. “We are also working to ensure healthy subjects, patients, and investigators participating in FAAH inhibitor clinical trials are fully informed of the risks and potential benefits of these experimental therapies.”