The National Agency for the Safety of Medicines and Health Products (ANSM) is reassuring after the death of two participants to one of the clinical trials. These deaths would have taken place within the framework of the Bacloville trial launched in 2012. But for the health agency, they would be linked to the psychological and physical fragility of the patients participating in these trials. These patients are subject “to many pathologies and to naturally high mortality, independently of these tests “, explains the ANSM before adding:” these elements are not likely, to date, to call into question the safety of the patients included in these tests “.
Baclofen prescribed for 50,000 heavy drinkers
Baclofen is a drug that has been used for 40 years as a muscle relaxant. Two clinical trials (the Bacloville trial in April 2012 and the Alpadir study last October), were launched to verify the supposed efficacy of the drug in the alcohol dependence treatment. A hypothesis that has made a lot of followers since the publication in 2008 of the book The Last Glass by Olivier Ameisen, a cardiologist, a former alcoholic, who claimed that baclofen had cut off any desire to drink. If these two clinical trials prove to be conclusive, baclofen could obtain a marketing authorization (MA). Today, despite the lack of MA, baclofen is prescribed to around 50,000 heavy drinkers in France.
