a recent decision by the Scientific Technical Committee of AIFA, the Italian agency of the drug, may lead to a restriction of the indications authorized for Alcover .
In practice it would only be indicated in acute withdrawal syndrome, and it would no longer be possible to use it in later stages, such as anticraving and to prevent relapse .
It is easy to understand how such a change worries the addiction clinicians. The drug has been in use in Italy for almost thirty years without significant problems, and has allowed thousands of people to free themselves from alcohol addiction. Such a restriction of indications would not only deprive addiction medicine of a unique instrument (there are no other drugs authorized in Italy for alcoholism with the same pharmacodynamic profile) but would pose a serious problem for existing drug treatments, for which one should hypothesize a suspension with times and modalities all to be determined, and a concrete risk of inducing relapse into alcoholism .
For this reason, the SITD National Executive issued a press release that we report below and also in printable PDF.
We invite members and clinicians interested in contacting AIFA through the online form made available to health professionals indicating their personal details, the company and the membership service, and their motivated opinion on this restriction of indications.
To WHOM IT MAY CONCERN
SITD COMMUNICATION FOLLOWING THE AIFA DECISION " Outcome Area Supervision Post Marketing CTS 29, 30 and 31 October 2018"
In recent days we have been informed that during the CTS meeting of 29-30-31 us, among the various drugs analyzed, a restriction of the indications of use of the drug Alcover oral solution was proposed .
Recall that the drug is distributed both in Italy and in Austria. In particular, in Italy it has been prescribed since 1991. The use of this drug during these 27 years has marked a fundamental and significant step in the pharmacological treatment of alcohol use disorder associated with psychosocial interventions (Biggio et al., 1992; Ferrara et al., 1992; Gallimberti et al., 1992; June et al., 1995; Addolorato et al., 1996, 1999, Beghè and Carpanini, 2000; Gessa et al., 2000; Stella et al., 2008) . Currently it is used with good results both for the treatment of the withdrawal syndrome and for the maintenance of abstention from alcohol, in particular in subjects with very high risk alcohol consumption (more than 100 g / day of alcohol for men) and more than 60 g / day of alcohol for women).(Gallimberti et al., 1989; Addolorato et al., 1996, 1998, 1999; Moncini et al., 2000; Nimmerrichter et al., 2002; Caputo et al., 2003, 2007; Nava et al., 2007; al., 2001, 2008, 2011; Maremmani et al., 2001, 2011, Cacciaglia et al., 2013; Skala et al., 2014, Caputo et al., 2015) .
Among the various treatments available, the Alcover is a therapeutic device of proven efficacy, witnessed by thousands of patients and numerous works in the literature (Addolorato et al., 1996; Stella et al., 2001, 2008; Keating, 2014; den Brink et al., 2018, etc.) , in an extremely disabling pathology, both in terms of life expectancy and in terms of social and health costs, direct or indirect (Rehm et al., 2018).
The limitation of therapeutic indications would certainly create a problem with unforeseeable consequences with a serious risk to the health of patients with alcohol dependence . In fact, the reduction of the indications given only for use in the abstinence crisis, would preclude treatment for a significant number of alcoholic patients with possible repercussions on the functioning of the Services with serious consequences for both health care workers and patients. It will be necessary to understand how it will be possible to guarantee the therapeutic continuity for the thousands and thousands of patients in maintenance treatment for the control of craving and how to manage a phase of transition that should lead to prescribe the drug only in control of withdrawal symptoms.
It is therefore obvious that, according to the above, our Company would urge all the Authors involved in the issue of reconsidering this decision, so that professionals can continue to prescribe in science and conscience the drug as happened in this almost last thirty years. , avoiding further unnecessary problems also because many have been told that denying access to the best care is a crime against humanity .
November 16, 2018
The National Direction
SITD Società Italiana Tossicodipendenze
ADDOLORATO, Giovanni, et al. An open multicentric study evaluating 4-hydroxybutyric acid sodium salt in the medium-term treatment of 179 alcohol dependent subjects. Alcohol and Alcoholism, 1996, 31.4: 341-345.
ADDOLORATO, Giovanni, et al. Maintaining abstinence from alcohol with γ-hydroxybutyric acid. The Lancet, 1998, 351.9095: 38.
ADDOLORATO, Giovanni, et al. γ-Hydroxybutyric acid in the treatment of alcoholism: dosage fractioning utilities in non-responders alcoholic patients. Drug and alcohol dependence, 1998, 53.1: 7-10.
ADDOLORATO, Giovanni, et al. Gamma-hydroxybutyric acid (GHB) in the treatment of alcohol withdrawal syndrome: a randomized comparative study versus benzodiazepine. Alcoholism: Clinical and Experimental Research, 1999, 23.10: 1596-1604.
BEGHÈ, Franco; CARPANINI, Maria Teresa. Safety and tolerability of gamma-hydroxybutyric acid in the treatment of alcohol-dependent patients. Alcohol, 2000, 20.3: 223-225.
BIGGIO, Giovanni, et al. Suppression of voluntary alcohol intake in rats and alcoholics by gamma-hydroxybutyric acid: a non-GABAergic mechanism. Advances in biochemical psychopharmacology, 1992, 47: 281-288.
CACCIAGLIA, Roberto et al., P30gate 2 Study: Sodium Oxybate in the Maintenance of Alcohol Abstinence and Prevention of Alcohol Relapse. Alcohol and Alcoholism, 2013, 48.suppl_1: i46-i49.
CAPUTO, Fabio, et al. Gamma-hydroxybutyric acid versus naltrexone in maintaining alcohol abstinence: an open randomized comparative study. Drug and alcohol dependence, 2003, 70.1: 85-91.