Hélène Géniaux

Evaluation of abuse and dependence in addiction monitoring systems: tramadol as an example.

The objective of this paper is to present an evaluation of the potential for abuse of and dependence on a drug from the data obtained from the different pharmacoepidemiological tools used by the French network for evaluation and information on pharmacodependence and addiction monitoring taking the example of tramadol. Comparison of the data from spontaneous reports with surveys in specific populations and with evaluations of indicators of diverted uses does not highlight a major problem of tramadol abuse and dependence in terms of public health, but stresses the importance of paying attention to the signal. This example of addiction monitoring of tramadol illustrates the interest of comparing results obtained from different validated sources. The implementation of repeated observational programs of abuse of and dependence on psychoactive drugs is an important aid to health authorities to define the content of the information to be delivered or regulatory decisions to reduce these problematic uses.

Safety profile of etifoxine: A French pharmacovigilance survey.

Etifoxine chlorhydrate is a benzoxazine derivative approved for the treatment of psychosomatic manifestations of anxiety since 1979. Previously labeled adverse drug reactions (ADRs) only include drowsiness, benign cutaneous reactions, and acute hypersensitivity reactions. The objectives were to examine recent data on etifoxine‐related ADR by reviewing Individual Case Safety Reports (ICSRs) recorded in France especially unexpected ADRs. Etifoxine‐related ICSRs were extracted from the French Pharmacovigilance database from 1 January 2000 to 30 April 2012 and data from the marketing authorization holder up to 31 December 2011 were also obtained. Of the 350 cases retained for analysis, 123 (35%) were considered serious. Dermatological or acute hypersensitivity reactions were the most frequent ADRs (59%) mainly isolated cutaneous eruptions. However, there were 24 cases of severe toxidermia (DRESS in 5, erythema multiforme in 10 and Stevens–Johnson syndrome in 5) with etifoxine as the most suspected drug in 11 patients, and seven cases of vasculitis or serum sickness‐like reaction. Liver disorders were reported in 34 patients of whom 25 developed acute hepatitis with a cytolytic biological pattern in 16. Other unexpected ADRs included 16 reversible cases of metrorrhagia with positive rechallenge in 5, and three cases of biopsy‐proven microscopic colitis of which one recurred after etifoxine re‐administration. Although etifoxine has been marketed for more than 30 years, this survey identified a number of unexpected and sometimes serious ADRs, in particularly severe toxidermia and acute cytolytic hepatitis. A recent update of the French etifoxine summary of the product characteristics (SPC) was based on these findings.

Probable interaction between an oral vitamin K antagonist and turmeric (Curcuma longa).

We report a probable interaction between a vitamin K antagonist, fluindione, and the herbal medicine turmeric that resulted in the elevation of the international normalized ratio (INR). The case presented here underlines the importance of considering potential exposure to herbal medications when assessing adverse effects.

Successful control of hidradenitis suppurativa with verapamil: a case report.

An inappropriate immunologic response has been suggested to play a role in the pathogenesis of hidradenitis suppurativa (HS). Adalimumab was the first TNF‐α inhibitor approved for moderate to severe HS. We report on a case of HS (Hurley stage 2) in a 39‐year‐old man, who had received fusidic acid and isotretinoin treatments without evident benefit during the last 8 years. The patient noticed a reduction in the number of lesions and quality of life (DLQI from 27 to 6) in the 2 months following verapamil initiation for cluster headache. When verapamil was stopped, the lesions recurred within 1.5 months. The patient resumed taking verapamil as before and a remission occurred. Verapamil has been shown to inhibit TNF‐α and IL‐1β in vitro and in vivo. We hypothesize that verapamil inhibits the inflammatory process through the TNF‐α/IL‐1 pathway involved in the HS physiopathology. Compared to biologic agents as anti‐TNF‐α (adalimumab) and anti‐IL1 (anakinra), verapamil is safer and cheaper. Given its possible role on TNF‐α/IL‐1, verapamil may represent an alternative therapeutic option in mild and moderate HS.