Editing Servier - Tianeptine Controversy (section)

==Regulatory Issues and Abuse Potential==
Despite being approved in France and other countries, tianeptine has never received FDA approval in the United States. The drug's μ-opioid receptor agonist properties give it a high abuse potential in large doses. Between 1989 and 2004, 141 cases of recreational use were identified in France, and an additional 45 cases between 2006 and 2011.

In 2007, following problems with dependency, tianeptine's manufacturer Servier agreed to modify the drug's label at the request of the French Health Products Safety Agency. This occurred after numerous cases of recreational use were identified in France between 1989 and 2004, indicating Servier was aware of the possibility that their initially proposed mechanism of action was wrong or at least incomplete. In 2001, Singapore restricted tianeptine prescribing to psychiatrists due to its recreational potential.  

Servier dealt with a similar case related to a product called benfluorex, which was originally marketed as a treatment for diabetes but was widely prescribed off-label as an appetite suppressant for weight loss. It was revealed that benfluorex had caused severe health problems in many patients, including heart valve damage resulting in numerous fatalities (estimates range from 500 to 2,000). The company was fined €2.7 million ($3.2 million) and several former Servier executives received suspended prison sentences.