Impact of the COVID-19 outbreak on the reporting of adverse drug reactions associated with self-medication.

OBJECTIVES: The primary objective of the present study was to describe the characteristics of adverse drug reactions (ADRs) linked to self-medication that were notified to the French Pharmacovigilance Database (FPVD) during the COVID-19 outbreak in 2020 first wave. The secondary objective was to compare the characteristics of these ADRs in 2020 with those notified during the same calendar period a year previously. MATERIAL AND METHODS: We analyzed ADRs recorded in the FPVD between March 15th and May 31st, 2020 vs. the same dates in 2019. Only ADRs linked to self-medication were analyzed. Descriptive statistics were used to obtain an overview of the types and characteristics of these ADRs. RESULTS: Of 3114 ADRs notified to the FPVD during the COVID-19 period in 2020, 114 (3.7%) were linked to self-medication. The equivalent proportion in 2019 was 1.6% (113 out of 7097). Half of the ADRs notified in 2020 were "serious". The median age of affected patients was 30.5, and 22% of the ADRs concerned children. Of the 114 ADRs linked to self-medication, 107 (66%) were for prescription-only drugs. The three mostly frequently suspected ATC classes were analgesics, psycholeptics, and antibacterials for systemic use. The most frequent ADRs were general disorders, gastrointestinal disorders, and nervous system disorders. The main difference between the non-COVID-19 period and the COVID-19 period was the higher proportion of medication errors during the latter. CONCLUSION: The present study is the first to have reported on ADRs linked to self-medication and notified during a COVID-19 outbreak. Further studies of self-medication patterns and their consequences in a pandemic context are mandatory and effective information on medication use (including self-medication and its dangers) during a pandemic is essential.

Fatal and life-threatening ADRs associated with paliperidone palmitate: an observational study in the French pharmacovigilance database.

INTRODUCTION: Paliperidone palmitate (PP), a long-acting intramuscular formulation of paliperidone, has been marketed in Europe within the last 10 years and provides an important treatment option for patients with schizophrenia.Our aim was to describe PP-related adverse drug reactions (ADRs) leading to death or life-threatening events, specifying their main clinical and pharmacological characteristics. METHODS: This observational study was a retrospective review of PP-related ADRs in the French pharmacovigilance database between January 1, 2013, and December 31, 2019. RESULTS: Out of 473 PP-related ADRs, we identified 13 deaths and 14 life-threatening events. ADRs were primarily cardiorespiratory (n = 17; 63%). Other symptoms observed were mainly metabolic (n = 4), digestive (n = 4), and neurological (n = 4). Cardiorespiratory symptoms were generally observed within first 6 months after initiation of treatment (11 out of 17 cases), unlike metabolic disorders (all 4 cases 12-21 months after initiation). Cardiac arrests and sudden unexpected deaths occurred 10-14 days after the last PP once-monthly injection (23 cases) or 11-24 days after the last PP three-monthly injection (remaining 4 cases). No PP blood concentration assays were performed for these patients. DISCUSSION: In this study, PP-related ADRs leading to death or life-threatening events mainly presented with cardiorespiratory symptoms and tended to occur in the first 6 months after the initiation of treatment and within postadministration periods aligned with peak plasma PP concentrations. The hypothesis of supratherapeutic drug concentrations following intramuscular PP injection must be raised. CONCLUSION: PP-related ADRs leading to death or life-threatening events mainly presented with cardiorespiratory symptoms. Cardiac arrests and sudden unexpected deaths following initiation of PP treatment could be due to supratherapeutic drug concentrations. This study highlights the need to monitor blood concentrations of PP.Key pointsAdverse reactions to paliperidone palmitate can lead to death or life-threatening events.It is hypothesized that cardiac arrests and sudden unexpected deaths following initiation of paliperidone palmitate treatment could be due to supratherapeutic drug concentrations.This paper proposes the need to monitor blood concentrations of paliperidone palmitate in future studies.

[Caustic necrosis due to topical formic acid 85% (Objectif ZeroVerrue(®))]. / Nécrose caustique sous acide formique à 85 % (Objectif ZeroVerrue(®)).

BACKGROUND: Formic acid 85% constitutes the active substance of a new wart removal agent marketed in France under the name of Objectif ZeroVerrue(®), a product sold over-the-counter for adults and children aged over four years, and on a doctor's recommendation for children aged under four years. Its mechanism of action may involve cellular destruction through dehydration. PATIENTS AND METHODS: Herein we report two cases of cutaneous necrosis following application of formic acid 85%. One case was severe, affecting the extremity of the middle finger and involving the underlying extensor apparatus in a girl aged 3 and a half years. This necrosis required the creation of a pedicled fasciocutaneous flap and temporary arthroereisis. DISCUSSION: The precautions for use set out in the information leaflet for this preparation based on formic acid must be strictly adhered to by patients. In particular, only one application should be made per week, taking care to avoid adjacent skin. It is essential to suspend treatment if the skin is still erythematous after the previous application, and the treated area must not be occluded with bandages. Doctors must be aware of the risk of necrosis, since their recommendation is required for children under the age of four years.