Pending the results of a study, the ANSM is renewing for one year the device for prescribing baclofen in the management of alcohol-dependent people.
In March 2014, the National Medicines Safety Agency (ANSM) drew up, for a period of 3 years, a Temporary Recommendation for Use (RTU) for baclofen in the care of alcohol-dependent patients.
And while two French trials recently delivered encouraging results on the effectiveness of the product, the ANSM has decided not to procrastinate any longer. She announces this Friday its decision to renew this system for a period of one year.
The modified Internet tracking portal
In parallel with this announcement, the ANSM recalls that it has set up a patient monitoring portal on the Internet. In the past three years, only around 7,000 patients have been registered there.
A proportion which seems very low in view of the estimate of all patients treated with baclofen in alcohol dependence. There are in fact more than 90,000 general practitioners in France who most certainly have alcohol dependents in their patients.
A new treatment protocol
In view of this low membership rate, the patient inclusion portal will be quite simply deleted, “this one having been considered too complex by the healthcare professionals and not having made it possible to identify new signals of pharmacovigilance “, explains the Agency.
And the RTU will also be changed. As of March 17, 2017, baclofen can now be prescribed as first-line treatment in the following two situations: helping to maintain abstinence after withdrawal; and reduction in alcohol consumption.
Caution before prescribing
Nevertheless, great caution is required when prescribing baclofen in patients with psychiatric disorders, because of the risk of aggravation of an underlying psychiatric pathology and / or the potential risk of suicide.
For patients with epilepsy or with a history of comitial seizures, and for whom a risk of lowering the epileptogenic threshold is possible due to the prescription of baclofen, this treatment should be initiated very gradually and close monitoring of the patient should be carried out throughout. along the prescription.
A progressive dosage
In addition, the ANSM considers it important to stress: on the one hand, that treatment with baclofen must be initiated very gradually and that the dosage must be adapted according to the tolerance and efficacy observed in the patient.
On the other hand, that the dosage of baclofen must also be reduced very gradually when stopping treatment, taking into account the risk of the occurrence of a baclofen withdrawal syndrome.
Finally, the ANSM recalls that any use of baclofen outside of clinical situations covered by the Marketing Authorization or the RTU generates risks and engages the responsibility of health professionals.
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