France: Baclofen authorized as a medication against alcoholism

[DonQuixote]

France: Baclofen authorized as a medication against alcoholism

Back to the topic: ?France: Baclofen authorized as a medication against alcoholism?

A ?temporary recommendation for usage? (French: recommandation temporaire d?utilisation, RTU) has been announced for June 2013, but unfortunately has not been established yet. There are no reliable informations about the case. Some people suppose, that a RTU could be established in February 2014. But it is known, that such a RTU will be very probably established under inappropriate conditions. See this French source: Baclofène : des médecins écrivent au directeur de l'ANSM - Sciences et Avenir

DonQuixote

[Federico]

France: Baclofen authorized as a medication against alcoholism

We should rather look positively to the future, in Cyprus the sun shines. In the UK, there will be a change in treatment guidelines for the treatment of alcohol dependence. In Spain and Portugal it was never a problem to buy baclofen in the pharmacy. In Germany, Austria and Switzerland, more and more doctors prescribe Baclofen. The neurologist Jerome Posner, once wrote to Olivier Ameisen: "Baclofen will prevail, precisely because it is effective in alcoholism." Probably he is right.

Federico

[DonQuixote]

France: Baclofen authorized as a medication against alcoholism

It means, that there have been lots of announcements but no real action. And it means, that the leaked drafts of the ?temporary recommendation for usage? foresee inappropriate conditions. All that means IMHO, that there is still a substantial antagonism in France against Baclofen as a therapy for alcoholism. I have veneration for all the French physicians that try to change paradigm.

DonQuixote

[Federico]

France: Baclofen authorized as a medication against alcoholism

Okay Don, it's finally your assertion (your topic) been to the you wanted back.
But the belief in change is already a change. Everything will be fine.

Federico

[Colin]

France: Baclofen authorized as a medication against alcoholism

Federico;1600419 wrote: Okay Don, it's finally your assertion (your topic) been to the you wanted back.
But the belief in change is already a change. Everything will be fine.

Federico

If one waits long enough all will be fine. Too bad about the people dying by the wayside as the ponderous medical elephant staggers onward.

[JDizzle]

France: Baclofen authorized as a medication against alcoholism

And from belief in change to change can be generations in between.

People in the 60s realized pot should not be illegal. We r just now slowly heading in that direction. I'm sure 1 or 2 alcoholics died from 1970 - 2013.

[Federico]

France: Baclofen authorized as a medication against alcoholism

And what do you think, are we going to make it very fast?
The brainwashing preacher of Alcoholics Anonymous return after ...
They were the ones who have 50 years demonizing each drug and many steps went back into the past.

Fedrico

[Otter]

France: Baclofen authorized as a medication against alcoholism

Shifts in public attitudes are hard. It is a bit unfair to blame the rehab industry, for instance, as being opposed to baclofen. Dr. Jonathan Chick was recently hired as a consultant by Castle Craig, which is the main rehab which the NHS refer patients to in Scotland and he is very pro-Baclofen. The NICE now knows about it and will likely publish something.

The real problem is that people generally are antagonistic because of alcohol related problems like drinking and driving, violence etc. The institutions which are responsible for dealing with these issues are "political" in the sense that they are very sensitive to public criticism and have to be seen to be "tough" on these problems. It is a very hard battle to fight because there are so many news commentaries about people being affected by drinking. Also, this morning on UK morning TV one guest on the news program joked about the concern over alcoholism, saying that the definition of an alcoholic is a person who drinks more than his doctor. The whole idea that alcoholism is an illness and an addiction still is not accepted in the UK where doctors on TV tell you to drink every day according to "health" guidelines. It is accepted in the UK that "everyone" drinks...everyone...so it can't be an illness or an addiction. No TV news presenter or producer is going to start calling everyone an addict or "ill".

The time will come, but it will be very slow coming, almost imperceptible.

[spiritwolf333]

France: Baclofen authorized as a medication against alcoholism

Alcohol, all over the world provides peace and joy to so many. Those that can enjoy and then put it down for a time can not understand why anyone else can not do the same. Thus, all around the globe alcohol abuse is a moral choice -not a disease, not a brain misalignment.

Furthermore, if you were not an alcoholic, ask yourself the question: Is alcoholism a moral choice or a disease. You see, the world does not look at alcoholism as a disease or a brain malfunction-instead, it is a moral decision to choose pleasure over less pleasure. With this mindset (even amongst alcoholics and many doctors), it will always be an up hill battle to get any drug approved for the use to offset alcoholism.

As Otter states, shifts in public perception and political perception are most difficult, at best, and we can only hope for the more slower shift in perception. Unless you are a desperate to recover alcoholic, alcoholism is not really a problem

[Federico]

France: Baclofen authorized as a medication against alcoholism

The nature of the dependence, the absence of free choice.
Unfortunately. With the desire for freedom was also advertised Marlboro.
Any change in thinking alcohol dependent people could help to save lives.
Is there agreement about? And if so, please quickly as possible.

The French baclofen doctors always say, "we have long searched but found nothing better ..."

beth ditto sings: "move in the right direction" I like this song very much.

Federico
Merry Christmas and a happy new year, if possible, with little or no alcohol

[Federico]

France: Baclofen authorized as a medication against alcoholism

News from France: All physicians of France, baclofen may prescribe!


The temporary admission (RTU) is valid from today under the following conditions.

Treatment goals: maintaining abstinence after alcohol withdrawal and / or
Reaching an acceptable use among risk drinkers:

Psycho-social support and medical expertise in alcoholism is assumed.
Baclofen may only be prescribed if other approved therapies have not been effective, but treatment has already begun may be continued.

Dosage: 15 - max. 300 mg / day. From 120 mg of the second opinion of an addiction specialist or a doctor with experience in alcoholism treatment must be obtained. From 180 mg / day, the prescription of a consultation with a specialist addiction medicine office needs.

Contraindications are neurological (due to possible adverse side effects) disorders, severe epilepsy and serious psychiatric disorders such as schizophrenia, bipolar, severe depression. Severe renal or hepatic insufficiency are also contraindicated.

The treatment data of outpatient prescriptions collected during the 3-year period in a database and in addition together with the two clinical trial data.

The RTU is valid for 3 years. A final approval for this indication is then possible, the data available for risk-benefit assessment was still too thin.

[emc]

France: Baclofen authorized as a medication against alcoholism

Thanks Federico.
It's a really important news even considering that the results of few Clinical Trial (mainly Alpadir and Bacloville) will arrive probably in next months.
And surely the fact that they collect data of this patients treated in RTU (Temporary Recommendation of Use) will give more strength to the future final DEF approval.

I open a thread just when I saw the news in French forum/websites, but sadly it gets completely unnoticed by the forum :-(
2014 Baclofen TMP approval in France

French Doctors they already start complaining about this restrictions.
See here in FR: RPU and direct link to GG translation FR -> EN HERE

[Calikime]

France: Baclofen authorized as a medication against alcoholism

Federico,
Thank you for your post. Can you elaborate on your statement, "Contraindications are neurological (due to possible adverse side effects) disorders, severe epilepsy and serious psychiatric disorders such as schizophrenia, bipolar, severe depression. Severe renal or hepatic insufficiency are also contraindicated."

Those are very serious conditions. Are you saying that using Baclofen can cause the above conditions or am I not understanding it correctly?
Thanks.

[emc]

France: Baclofen authorized as a medication against alcoholism

Hi Calikime,
no, is not at all like that.

It means that there are restrictions in prescribing Baclofen for Alcoholism that EXCLUDE people having this kind of neurological/psycological/physical problem.
It says... "Contraindications are..." means: you cannot use it in patients w this conditions.

A group of psychiatrist + Addiction Associations already start to complain about this.
Let's see if they will arrive to make remove some limitation.

[Calikime]

France: Baclofen authorized as a medication against alcoholism

Thanks EMC for the clarification. I also took your sleep survey, thanks for having that. I plan to post my journey with Baclofen hopefully soon. I am still going up on my dose at the moment and want to post when I reach my switch dose. I am taking it very slowly in terms of increasing my dose so it is taking me longer than some.