Baclofen used in high doses (300 mg per day) in the treatment of alcoholism was too risky, said the French drug agency.
The transition may be difficult for some alcohol-dependent patients. The French Medicines Safety Agency (ANSM) has decided to modify the protocol for the use of baclofen in the treatment of alcoholism. The maximum prescribed dose is increased from 300 to 80 mg per day.
Since 2014, the drug has benefited from a temporary recommendation for use (RTU) which was renewed in early 2017. It involved strict monitoring of any side effects. But the results of a study by ANSM and Inserm recently showed an increased risk of hospitalization and death when the drug is prescribed in high doses.
Misuse
Baclofen is a muscle relaxant used since the 1970s in the treatment of muscle contractures and spasms, especially in multiple sclerosis, at doses equivalent to a few tens of mg per day, at most. But the book The last drink by Dr Olivier Ameisen, published in 2008, opened up the possibilities.
The cardiologist, now deceased, affirmed that the drug had helped him in his own withdrawal. Studies have confirmed its usefulness in reducing consumption in alcohol-dependent patients, when prescribed in high doses. This had prompted the ANSM to grant an RTU for use at 300 mg / d.
Gradual reduction
But faced with the risks, the French agency is now taking a step back. She updated the RTU. Since July 24, the maximum prescribed dose has been limited to 80 mg / day.
This new dosage cannot be implemented overnight for patients. “The treatment should be gradually reduced, explains the ANSM in a press release. A letter is sent to healthcare professionals to inform them of this new measure and of the special precautions to be taken around this prescription. The updated RTU protocol is available on the ANSM website. For patients taking more than 80 mg / day, she advises reducing the dose in steps of 10 to 15 mg every other day.
It also recalls that baclofen is strongly discouraged in patients with psychiatric disorders, “because of the risk of aggravation of an underlying psychiatric pathology and / or the potential risk of suicide”. In people at risk for epilepsy, it must also be “started very gradually”.
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