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Baclofen‐induced edema in alcohol use disorders

Although alcohol use disorders (AUDs) constitute an important burden of disease in Europe, the currently approved medications remain insufficiently efficacious, and off‐label drugs may be required. Baclofen is a gamma‐amino butyric acid type B (GABA‐B) receptor agonist that was originally approved for spasticity. In this indication, baclofen can be delivered orally or intrathecally. Recently, baclofen 30mg/day has been reported to be a promising therapeutic option for AUDs. Moreover, a baclofen dose–response effect has been suspected in AUDs, and high‐dose baclofen (HDB), that is, more than 80mg/day, is increasingly being used in current clinical practice. However, the global tolerability of baclofen at such doses remains largely unexplored. Some types of adverse drug reactions (ADRs) may occur at high doses and may even be preferentially induced in patients with persistent alcohol abuse. Due to the lack of data, several addiction centers of the Nord‐Pas‐de‐Calais region, France, have joined with the regional department of pharmacovigilance to create a system named CAMTEA, which delivers HDB prescriptions for AUDs only under strict monitoring, including follow‐up by pharmacovigilance specialists, to better spot ADRs. Such a system may thus detect ADRs that were not described with the oral form at a dose of 80mg/day or in patients without an AUD. Recently, a national pharmacovigilance report in France found that off‐label baclofen could induce previously unknown ADRs. Notably, this identified lower extremity edema. However, in this document, ADRs were not assessed using validated methods for determining causality. We report herein the occurrence of lower extremity edema in three patients with persistent AUDs during their off‐label treatment with baclofen. In each case, the causality of baclofen in triggering edema was assessed using Naranjo’s scale, which is a validated tool for determining the likelihood that a given drug induced a specific ADR. Case Series