Fundam Clin Pharmacol

BACKGROUND: The combination dextropropoxyphene/paracetamol (DXP/P) was the most prescribed opioid analgesic until its withdrawal in 2011. OBJECTIVES: This study investigated dispensations of analgesics in chronic users of DXP/P during the 18 months following its withdrawal. METHODS: A cross-sectional study repeated yearly was conducted by using the French reimbursement database from 2006 to 2015. Chronic DXP/P users were defined as patients who received at least 40 boxes of DXP/P in the year prior to withdrawal. Data on analgesic dispensing were analyzed at DXP/P withdrawal (T0) and then every 6 months for 18 months. RESULTS: A total of 63 671 subjects had a DXP/P reimbursement in the year prior to its discontinuation, of whom 7.1% were identified as chronic users (mean age: 71.5 years, women: 68.7%). Among the patients taking DXP/P alone at T0 (74.6%), one fourth switched to a peripheral analgesic, one fourth to a combination of peripheral analgesic/opioid, one fourth to another opioid, and the others mainly discontinued their treatment (14.1%) or died. During the following 12 months, most of the subjects taking only peripheral analgesics continued this treatment, while half of the subjects with a combination of opioid/peripheral analgesic or taking only an analgesic remained on this type of treatment. CONCLUSION: Eighteen months after DXP/P withdrawal, more than 10% of patients stopped taking an analgesic. Vigilance is required regarding any change in analgesics by regularly reassessing patients' pain and, in the case of opioid treatments, by monitoring the risk of use disorders

Pharmacovigilance et recueil des données sur le risque des médicaments dans le cadre des études observationnelles

BORDEAUX2-BU Santé (330632101) / SudocSudocFranceF

Evaluation du risque associé à la prescription médicamenteuse chez le sujet agé (étude de faisabilité)

BORDEAUX2-BU Santé (330632101) / SudocSudocFranceF

Safety of levonorgestrel 52mg intrauterine system compared to copper intrauterine device: a population-based cohort study

OBJECTIVE: To compare the risk of all-cause death, hospitalizations (any cause), ectopic pregnancy, pelvic inflammatory disease or infection, uterine perforation, device removal, neuro-psychiatric drugs initiation, or new psychiatric visit(s) between levonorgestrel (LNG) 52mg intrauterine system (IUS) and copper intrauterine device (IUD) users in France. STUDY DESIGN: We identified a historical cohort of women aged 20-55years with a first dispensing of either LNG 52mg IUS or copper-IUD between January 1, 2010 and December 31, 2014, in the French National Claims database, SNDS. We used propensity score matching to balance the two groups on baseline sociodemographic and clinical characteristics to minimize confounding. We estimated Cox proportional hazards models to compare health outcomes between LNG 52mg IUS and copper-IUDs users. RESULTS: We matched 9318 LNG 52mg IUS users (mean age 36.2+/-6.8years) to 10,185 copper-IUD users (mean age 35.4+/-7.1years). After matching and age-adjustment, LNG 52mg IUS users had a slightly higher risk of anxiolytic drugs initiation (HR 1.08, 95%CI 1.01 to 1.15) and device removal (HR 1.05, 95%CI 1.01 to 1.10) compared to copper-IUD users, with no differences for other studied outcomes. CONCLUSION: French IUS users report slightly more anxiolytic treatment initiation and IUD removal compared to copper-IUD users. These results are consistent with a potential pharmacovigilance signal of anxiety-related disorders in LNG 52mg IUS users. IMPLICATIONS STATEMENT: In French LNG 52mg IUS users, there was slightly more anxiolytic treatment initiation and IUD removal compared to copper-IUD users. No risk difference was found for all-cause death, hospitalizations, ectopic pregnancy, pelvic disorders, and uterine perforation. We cannot exclude that the associations are related to differences in characteristics of women who chose each type of type of IUD

Therapie

Addictovigilance in the French Public Health Code, in the section related to poisonous substances, refers to a monitoring system developed since 1990: control of psychoactive substances and products, with medicinal use or not, was completed by a specific system focused on evaluation and information on pharmacodependance in 1999. The French medicines agency (Agence du medicament) created in 1993 was involved in this monitoring system; pharmacodependance evaluation was added by law to the missions of the agencies that followed: the Agence francaise de securite sanitaire des produits de sante missions (AFSSAPS, 1998) and the Agence nationale de securite du medicament et des produits de sante (ANSM, 2011). "Addictovigilance" first appears in French Law in 2017 whereas it was used by pharmacodependance centers and AFSSAPS since 2007. Legal definition of addictovigilance in the French Public Health Code testified to public authorities action against addictive behavior whatever products status, legal or not. The visibility of addictovigilance is growing on the Internet as well (ANSM website, web portal for reporting adverse health events)

Second-degree burn induced by high-concentration topical capsaicin with mobility sequelae: a case report

International audienceHigh-concentration topical capsaicin is used as a second line treatment for neuropathic pain. Transient, mild burning sensation and erythema are expected adverse drug reactions. Here, we report the first case of second degree burn after the application of a high-concentration topical capsaicin patch with secondary mobility sequelae. Nine months after the application, neuropathic pain still remained and the patient described mobility difficulties in daily activities, preventing her from returning to work. This report aims to raise the question of the benefit/risk ratio of high concentration topical capsaicin

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

Relevance of a "Dear Doctor letter" to alert healthcare providers to new recommendations for vitamin D administration

International audienceAfter reports of malaise in infants immediately after the oral administration of two brands of vitamin D solutions, a "Dear Doctor letter" (DDL) containing recommendations for the administration of vitamin D was sent to all French paediatricians and pharmacies and a large number of French general practitioners (GPs) with a predominantly paediatric practice. The DDL and a press release were published on the French Medicines Agency website and distributed via a mailing list. The objective of this study was to assess the effectiveness of such a DDL and to collect the opinions of healthcare professionals on the best way to provide them with information. METHODS: A questionnaire was sent to a national random sample of 145 paediatricians, 680 GPs and 230 pharmacists. RESULTS: Only 49% of responding paediatricians, 48% of GPs and 67% of pharmacists were aware of the warning. Among the participating healthcare professionals aware of the warning and who prescribed/dispensed these vitamins, 50% of paediatricians and 68% of GPs stated that they had changed their prescribing behaviour, and 68% of pharmacists stated that they had modified their advice when dispensing. According to the responding healthcare professionals, postal letters remained the best way to issue safety warnings. Some of the respondents suggested that the DDL be more distinctive in terms of being a DDL and that the information be more widely disseminated to other stakeholders involved in the healthcare system. CONCLUSIONS: This survey of a national random sample of healthcare professionals revealed that many of the respondents paid little attention to the DDL and were therefore unlikely to change their practices. A potential supplementary method for disseminating recommendations for medicine administration could be to apply stickers on medicine boxes, as this approach has the additional advantage of directly informing the concerned population, i.e. the parents