Ansm restrict Baclofen Prescription to 80mg day in France

[Baclofenman]

So, it appears the godfathers of Baclofen prescribing are being censored by the authorities now.

Google Translate

I have not had chance to look into this story but it is worth a post!

Regards,


Bacman

[_serenity_]

Re: Ansm restrict Baclofen Prescription to 80mg day in France

Link is not working - I just see a Google Translate page stating that the page I am attempting to translate is already in English. It won't let me navigate the links either.

[Baclofenman]

Re: Ansm restrict Baclofen Prescription to 80mg day in France

Link is not working - I just see a Google Translate page stating that the page I am attempting to translate is already in English. It won't let me navigate the links either.

Oh yeah...Sorry

Try This One - But you will need to use your own translator

Regards


Bacman

[Otter]

Re: Ansm restrict Baclofen Prescription to 80mg day in France

The members of the baclofen forum in France are asking people to sign a petition.

I think what has happened is that drug companies have finally realized that they have to stop the use of high dose baclofen or all their own projects will go nowhere. This was, sadly, inevitable. Here is a link to an article about the corruption of the French alcoholism agencies. http://www.latribune.fr/entreprises-...ts-663488.html

I have copied the info from the French site with the email address.

Can everyone send this out and see if we can make this go "viral", at least on the forum.

Here are the details:

Despite the numerous protests of users and prescribers, the ANSM has just formalized its revision of the RTU with a dose limitation to 80mg per day. Reduction of the maximum dose of baclofen to 80mg per day under the Temporary Use Recommendation (RTU) - Communiqué It is a real disaster for all those who have emerged from addiction and are always at higher doses and A loss of chance unacceptable to all others. A new forum, signed by many prescribers, has just been published: For a rational and framed prescription of baclofen A petition, to be signed en masse , has just been put online at the initiative of the spouse of an alcohol-dependent: Baclofen saves lives, save baclofen On our side, we will also intervene very quickly using the testimonials we will receive at this address: temoignages@baclofene.fr . Thank you very much to testify as a patient out of business or revolted by this decision. We will preserve your anonymity if you specify it, and we will inform all the witnesses of the steps taken to the media, the health authorities and the policies to which we will have added your stories. Be very numerous to testify as a patient out of business or revolted by this decision. We will preserve your anonymity if you specify it, and we will inform all the witnesses of the steps taken to the media, the health authorities and the policies to which we will have added your stories. Be very numerous to testify as a patient out of business or revolted by this decision. We will preserve your anonymity if you specify it, and we will inform all the witnesses of the steps taken to the media, the health authorities and the policies to which we will have added your stories.

[Otter]

Re: Ansm restrict Baclofen Prescription to 80mg day in France

I have written in support of the petition mentioned above and would ask that everyone who is concerned about this issue sends a testimonial. It can be in English. I just heard back from them as follows:

Thank you!

Marion Gaud

Porte Parole de AUBES

[Otter]

Re: Ansm restrict Baclofen Prescription to 80mg day in France

The decision of the French medicines board ANSM has now resulted in the Baclofen users association circulating an informed consent form so that users can still get high dose baclofen:

I've run it through Google Translate so please excuse the translation:

Information form for people who apply for benefits
Treatment with high-dose baclofen
I, the undersigned, certify that:
- Ask personally for Baclofen for my alcohol dependence.
- Have taken the initiative of soliciting myself the Dr to be able to benefit
Of this treatment.
- Have been informed of all contraindications of Baclofen and precautions for use
When taking a Baclofen treatment, in particular:
• Treatment with baclofen should never be interrupted abruptly. Its interruption
Can lead to mental confusion, delirium,
Hallucinations, dyskinesias and epileptic seizures.
• Treatment with baclofen should be very conservative in people who have
Renal disease, urinary disease, liver disease, respiratory disease,
Cardiovascular disease, gastric or duodenal ulcer, disease
Neurological disorder or psychiatric illness.
• I have to continue my anti-epileptic treatment if I take one.
• If treated for high blood pressure, baclofen may potentiate the effects
Of this treatment, I should therefore monitor my blood pressure, and possibly adapt
My treatment.
• I must be particularly careful if I take one or more of the following treatments:
Antidepressant, so-called substitution therapy (methadone or buprenorphine), anxiolytic,
Hypnotic, neuroleptic, antihistamine, antiparkinsonian.
- Have been informed of all adverse events likely to be associated with the
Of a treatment with baclofen, in particular:
• Tiredness, drowsiness and dizziness: these are the most common adverse events
They often occur at the beginning of treatment, but also when using
Doses, they may be related to too rapid increases in doses.
• Fatigue, drowsiness and dizziness are more common in people with
History of psychiatric disorders or history of cerebrovascular
Among the elderly.
• Baclofen can promote epileptic seizures in epileptics, aggravate
Urine in those who already have it, and aggravate neuro-muscular spasms in
People with neurological disorders.
• More rarely, baclofen may be responsible for: mental confusion,
Respiratory, muscular hypotonia, nervous breakdown, headache, tinnitus,
Paraesthesia, insomnia, tremors, difficulty speaking, impaired vision, nausea,
Vomiting, constipation, diarrhea, anorexia, dry mouth, taste disorder,
Hypotension, slow heart, sweating, rash.
- Have been informed of the possibility of prescribing high doses of baclofen (doses
Will be gradually increased to a dose of up to 300 milligrams per
But do not generally reach this dose because the dose will be adjusted according to my
Clinical condition).
- Have been informed that this treatment was outside the usual indication of baclofen
(Ie excluding Marketing authorization, or non-marketing authorization) and non-RTU.
- Allow my doctor to ask me about my state of health, my environment
Social, family and professional, as well as the history of my problems with alcohol. And him
To have responded sincerely concerning, in particular, the diseases for which the
Baclofen is contraindicated or requires caution.
- Commit me not to prosecute in the event that incidents or accidents
Occur in my life, potentially attributable to baclofen.
- Commit me not to pursue the pharmacy and the pharmacist
In the event of incidents or accidents occurring in my life,
Potentially attributable to baclofen.
.
Done in triplicate
AT
The
signatures
Preceded read and approved:


Here is the email explaining how this form is intended to be used:

Good evening everyone,

Until we get that ANSM reverse its position, for those of you who are at higher doses than 80mg, here's what you can try to keep your current prescription:

Complete and sign three copies of the "landfill" attached to mention that you not fight in court or your prescriber or pharmacist in case of serious incidents due to baclofen. One for you, one for your doctor, to pharmacist.

We do not guarantee that it will bend. But we must always try. You can also add, if your pharmacist is always reluctant, you can, attack him for endangering others if you relapse because of his refusal.

Good luck to all, we continue our efforts and research to overcome this impasse.

The team BLADES

[Otter]

Re: Ansm restrict Baclofen Prescription to 80mg day in France

Here is the latest on this mess:

http://www.ordre.pharmacien.fr/Communications/Les-actualites/Baclofene-pas-d-interruption-ou-de-reduction-brutale-de-traitement

From this it appears that the French association of pharmacists has advised not to reduce dosage without the advice of a doctor and to continue at the prescribed dosage in the meantime:

"Therefore, for patients currently receiving doses greater than 80 mg / d baclofen, the following should be indicated:
- to consult their doctor as soon as possible, in order to initiate a gradual reduction of the dosage, and
- not to reduce or stop their treatment on their own.
Pending further medical consultation, treatment should be provided in accordance with the patient's prescription."

On the one hand I am inclined to try to "do" something about this, beyond just watching it all unfold. On the other, since we are "ok" because, 1, my wife is now abstinent and not relapsing on a low dose of about 40 mg a day plus Campral and, 2, we can get any amount of genuine Liorosal we want without a prescription from any local pharmacy, I'm not inclined to do anything. Not, of course, that I have any idea what I could do anyway.

I would like to know what the figures are on hospital admissions with baclofen treatment and how it compares with the hospitalization and deaths of advanced stage alcoholics who are not treated. I don't know any seriously ill alcoholics, ever, who have taken drugs like Campral or Naltrexone and in our case, neither of them worked at all or on their own so I would think that the recorded suicide rate of alcoholics on either of these drugs, attributable to either drug is "zero", whereas baclofen treatment results in a shift from constant craving to a sudden, and often challenging, sobriety.

I would expect this will generate a lot of heat and controversy in the alcohol research arena in France. Seems utterly cynical and dishonest to me. I think something stinks here.

[Baclofenman]

Re: Ansm restrict Baclofen Prescription to 80mg day in France

my wife is now abstinent and not relapsing on a low dose of about 40 mg a day plus Campral

What fantastic news Otter. Hopefully things are returning to a (sort of) normality in the den

"Therefore, for patients currently receiving doses greater than 80 mg / d baclofen, the following should be indicated:
- to consult their doctor as soon as possible, in order to initiate a gradual reduction of the dosage

That seems odd. Usually, when a change as strong as this is implemented, it applies to "new customers only" . Existing "customers" are normally left in the position or plan they are already on

It could be that Ansm have decided they have made a terrible mistake, or it could be as you suggest - Fishy (As Baldricks apple crumble)

Regards



Bacman

[Mom21961]

Re: Ansm restrict Baclofen Prescription to 80mg day in France

[MENTION=12219]Otter[/MENTION] how much Campral is your wife taking? I'd like to reduce my Baclofen and am thinking of adding Campral.

[Otter]

Re: Ansm restrict Baclofen Prescription to 80mg day in France

[MENTION=12219]Otter[/MENTION] how much Campral is your wife taking? I'd like to reduce my Baclofen and am thinking of adding Campral.

She takes one pill, 333mg in the morning. Seems to be enough. She takes 20 mg bac morning and 20 mg at night.

[Otter]

Re: Ansm restrict Baclofen Prescription to 80mg day in France

Does anyone have a comprehensive list of English language research, videos, resources on baclofen? I have the info off TEOMA.

[Otter]

Re: Ansm restrict Baclofen Prescription to 80mg day in France

The French medical safety board has now issue further directions which allow high dose baclofen to existing users:

Hello,
Attached is the letter from ANSM to health professionals dated August 11, which contains this important sentence:
"It is possible to prescribe and issue baclofen, excluding AMM and non-RTU, under the responsibility of the healthcare professionals concerned, who are then obliged to inform patients of the benefits and risks expected in this situation."
And reminds pharmacists that in the absence of a new prescription by the physician, they must deliver the one that appears on the prescription.
You can of course print and show this document to the pharmacists if they refuse your prescription beyond 80mg
The team of AUBES

They are now going to have to think about new patients and new prescriptions because it is a person's right to have treatment and to take risks if they want to take those risks, so long as they understand them. I am told that the information about suicides etc on baclofen is very weak. We shall see what happens.