As of July 24, doctors are no longer allowed to prescribe high-dose baclofen. A loss of opportunity for some patients.
Baclofen can no longer be prescribed at doses greater than 80 mg / day. This decision of the Medicines Agency (ANSM) was announced on Tuesday July 25 and must be applied as of today by doctors. On social networks, practitioners, associations of users and prescribers denounce a brutal decision taken without consultation with actors in the field.
For the ANSM, limiting the maximum dose is a precautionary measure. It based its decision on a study conducted by its services, Health Insurance and Inserm and presented in early July. “The results show that the risk of hospitalization and death increases very clearly with the dose of baclofen prescribed,” recalls Professor Michel Reynaud, joined by Why? We have to take this into account. But this study also reminds us that few patients take doses greater than 180 mg / day. “
“Doctors have to fend for themselves”
To treat their alcohol dependence, about 3% of patients receive doses over 180 mg / day and up to 300 mg of baclofen. Patients who will therefore see the dosage of their treatment divided by 2 or 3 almost overnight. “Doctors have received many calls from patients distressed by this announcement,” indicates Jean-Pierre Couteron, president of Fédération Addiction. And among them, there are patients who are doing well and who are followed by their doctor. It is never easy to change the balance of a treatment, especially if it was good ”.
Especially since the period does not lend itself to it. “We are in the middle of the holidays. Doctors must manage this new decision in addition to that of codeine at a time when some practices are closed and addictology care centers are lacking staff, regrets Jean-Pierre Couteron. The ANSM made its decision without taking into account the people who must implement it, and now leaves them to fend for themselves ”.
Better frame the prescription
Same story with Professor Reynaud. If he judges that the ANSM’s decision “is understandable in view of the problems they encountered with the Mediator and other drugs”, he deplores the lack of consultation. He also recalls that this decision could compromise the recovery of thousands of patients.
To date, studies have not yet demonstrated a link between the dose and the effectiveness of the treatment. Doctors therefore prescribe this molecule on a case-by-case basis, gradually increasing the dose. The addictologist estimates that limiting the maximum dose to 80 mg will lose chances for patients who could have benefited from larger doses. “Beyond 80 mg / day, I think that it is necessary to set up a close collaboration between the attending physician and a team specialized in addictology to treat the comorbidities, the psychiatric disorders as well as the co-consumption, and to avoid the heavy alcohol consumption under baclofen ”.
Activist doctors have already announced that they will not respect the new prescription conditions. The two specialists fear that this ANSM decision will relaunch “unhealthy” discussions around this drug and call for a calm debate. “Thanks to baclofen, the number of patients followed for alcohol problems has doubled in 5 years. We have gone from over 100,000 patients to 200,000 every year, which is huge progress. It is now a question of finding the place of this drug in the therapeutic arsenal against alcoholism, ”concludes Professor Reynaud.
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