The Risk of Worsening Infections under Non-steroidal Anti-inflammatory: A French Observational Study

Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are frequently used to relieve pain, fever or inflammation; and information on secondary infectious risk is unclear. The aim of our study is to describe the cases of worsening infections under NSAIDs to question the risk. Methods: To investigate this potential risk, we performed a prospective, observational and single-center study. Results: In total, 28 cases of worsening infection after exposure to NSAIDs were included in the study. The most frequently involved NSAID was ibuprofen (64%) and the NSAIDs were primarily used as painkiller (47%) and against fever (35%). The most frequent sites of infection were cutaneous (32%) and pulmonary (22%). We noted that the infection was resolved for 86% of our patients. The most serious cases required admission to the intensive care unit (14%) and one patient died. Conclusions: The wide diversity of cases observed in our small group of patients suggests that all types of infection may be concerned. Other analgesic or antipyretic drugs should be preferred over NSAIDs when there is suspected infection. Information has to be more transparent regarding to the potential risk of serious worsening of infection after exposure to NSAIDs. *Corresponding Author: Dr. Quentin Jarrion, Centre Régional de Pharmacovigilance et de Pharmacoépidémiologie de Champagne-Ardenne Centre Hospitalier Universitaire de Reims, Avenue du Général Koening, 51092 Reims Cedex, France, Tel: +33642777059, Fax : +33326832379; E-mail: quentinjarrion@yahoo.fr Citation: Jarrion Q, Krabansky F, Azzouz B, Morel A, Trenque T, et al. (2020) The Risk of Worsening Infections under Non-steroidal Anti-inflammatory: A French Observational Study. Int J Clin Pharmacol Pharmacother 5: 147. doi: https://doi. org/10.15344/2456-3501/2020/147 Copyright: © 2020 Jarrion et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. International Journal of Clinical Pharmacology & Pharmacotherapy Quentin Jarrion*, François Krabansky, Brahim Azzouz, Aurore Morel and Thierry Trenque Departement of Pharmacovigilance and Pharmacoepidemiology, Centre Hospitalier Universitaire de Reims, Reims, Champagne-Ardenne, FR 51092, France Int J Clin Pharmacol Pharmacother IJCPP, an open access journal ISSN: 2456-3501 Volume 5. 2020. 147 Jarrion et al,. Int J Clin Pharmacol Pharmacother 2020, 5: 147 https://doi.org/10.15344/2456-3501/2020/147 accordance with the approved guidelines of the institutional review board of Reims University Hospital and in accordance with the 1964 Declaration of Helsinki. Each patient and parent/legal guardian, for patients under 18, provided oral informed consent before conducting the experiments in accordance with relevant guidelines and regulations. Worsening infection was judged by the clinicians who follow patients on the criteria of: onset of complications of infection, dissemination of infection, abscess, unexpectedly serious signs, and prolonged need for treatment, severe sepsis or septic shock. The exposure to NSAIDs had to have occurred prior to the initial suspicion of infection, and worsening had to have occurred after the ingestion of NSAIDs without more evident causes. If there was any doubt about the chronology of the exposure to NSAIDs, occurrence of the primary endpoint, or strong confounders for the worsening, the patient was excluded. For all patients, we recorded sex, age, the ward where the patient was hospitalized, the drug suspected of involvement, the indication for the prescription, the site of the initial infection, the site of the worsening observed, the type of worsening, the need for admission to the intensive care unit, the concomitant drugs throughout the complication, the type of NSAID administration (self-medication or not), the outcome (resolved, sequelae, death), the alternating prescription of paracetamol and NSAIDs and the time to onset. Introduction Non-steroidal anti-inflammatory drugs (NSAIDs) are frequently used as painkillers, and to treat fever and inflammation. Several NSAIDs are available over the counter for self-medication, and are sometimes used inappropriately. And even if the French National Agency for Medicines and Health Products Safety (ANSM) recently sounded the alarm on the use of NSAIDs in a context of infection [1], it has never been convincingly demonstrated that taking these products can cause an ongoing infection to worsen, and a new warning about the risk of using these products in an infectious situation is always an interesting signal in terms of public health. Information on the packaging of NSAIDs is vague and rather reassuring regarding secondary infectious risks. Besides, available data in this regard are conflicting, with studies focusing on only one type of infection, or a specific patient population. The largest body of evidence exists in the context of cutaneous infections and complications occurring in children [1]. In this context, we decided to perform a prospective and observational study of worsening infection following exposure to NSAIDs in two specialized wards of a university hospital over a period of one year. The objective was to collect the cases occurring in this setting, to describe the types of patients affected, the drugs used, the circumstances of the occurrence, as well as the type of infection and deterioration observed.