The higher the dose of baclofen, the greater the risk of hospitalization and death. The RTU should be revised.
4 years ago, baclofen was presented as the miracle drug against alcoholism. Since then, scientific work on this drug, initially indicated for multiple sclerosis, has been mixed. A new study by the National Health Insurance Fund (Cnamts) and the National Medicines Safety Agency (ANSM) shows that beyond a daily dose of 180 mg, the risk of hospitalization and deaths increase dramatically.
To carry out their work, the two agencies relied on the health insurance databases that they crossed with those of the Center for epidemiology on medical causes of death (CépiDc). The analysis was carried out in collaboration with researchers from Inserm.
Between 2009 and 2015, it appears that more than 213,000 patients received this drug for an indication other than multiple sclerosis. The vast majority, around 200,000 people, have used it to treat their alcohol addiction.
Low compliance
But these patients were not very observant, according to this study. In the first 6 months of use, only 10% took it without stopping. “Ultimately, as for the drugs indicated in alcohol dependence, more than 4 out of 5 patients starting treatment with baclofen definitively stop it during the first six months of use”, note the Cnamts and the ANSM.
Treatment with baclofen can be cumbersome. While patients needing high doses to free themselves from their desire to drink are in the minority, the authors have nonetheless identified 1,400 patients treated with doses of between 180 and 300 mg per day and 935 people were prescribed more than 300 mg / day. Or nearly 30 tablets per day.
Risk of death multiplied by 2
However, the higher the dose, the greater the risk of hospitalization and death, alert Health Insurance and the ANSM. By comparing them with “classic” withdrawal drugs, the authors show that the risk of hospitalization increases by 15% with doses ranging from 75 mg / day to 180 mg / day. The risk of death is multiplied by 1.5.
Beyond 180 mg / day, the frequency of hospitalizations is increased by 46% and the risk of death is multiplied by 2.27. “In particular, the risk of intoxication, epilepsy and unexplained death (according to the death certificate) increases with the dose of baclofen received”, they specify.
In view of these safety data, the ANSM announces that it will initiate a review of the baclofen RTU. She adds that these results will be taken into account as part of the MA application file for the treatment of alcohol dependence currently under evaluation.
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