Adverse drug reactions associated with the use of NSAIDs: a case/noncase analysis of spontaneous reports from the French pharmacovigilance database 2002–2006

Abstract

To evaluate the safety profile of eight oral nonsteroidal anti-inflammatory drugs (NSAIDs) available in France, using data reported through the French pharmacovigilance system. Data (from 2002 to 2006) were analysed for aceclofenac, diclofenac, ketoprofen, meloxicam, naproxen, nimesulide, piroxicam and tenoxicam, focusing on the reported rates of serious adverse drug reactions (ADRs) in the following system organ classes: gastrointestinal, hepatic, cutaneous, renal and cardiovascular. A total of 42 389 serious ADR reports were identified, and 38 506 were included in a case/noncase analysis. Ketoprofen was associated with the highest cumulative reported rate of serious ADRs (0.78 cases per million defined daily doses), followed by diclofenac (0.58), nimesulide (0.52), naproxen (0.50), piroxicam (0.47), tenoxicam (0.42), meloxicam (0.41) and aceclofenac (0.30). The most frequently reported serious ADRs were cutaneous, followed by gastrointestinal, hepatic, renal and rarely, cardiovascular events. In the case/noncase analysis, ketoprofen, piroxicam and naproxen were associated with the highest risk of serious gastrointestinal ADRs (odds ratios [ORs] of 6.87, 6.54 and 5.07, respectively). Nimesulide and aceclofenac were associated with the highest risk of liver ADRs (adjusted ORs of 4.53 and 3.67, respectively), as was meloxicam for cutaneous ADRs (adjusted OR of 3.15) and tenoxicam for renal ADRs (adjusted OR of 3.17). The most frequent serious ADRs reported with the selected oral NSAIDs are cutaneous, followed by gastrointestinal, hepatic and renal events. The highest risks for serious gastrointestinal, hepatic, cutaneous and renal adverse events were linked, respectively, with ketoprofen, nimesulide, meloxicam and tenoxicam compared with the other NSAIDs.

The effect of COX-2-selective meloxicam on the myocardial, vascular and renal risks: a systematic review

“…Seven studies (Arvind et al 2004;Hosie et al 1996;Lafrance and Miller 2012;Lapeyre-Mestre et al 2013;Schneider et al 2006;Shi et al 2004;Winkelmayer et al 2008) were found reporting meloxicam exposure of any duration and its effect on renal system (Table 3). Meloxicam was found with no increase in renal risk OR 0 , neither did ibuprofen.…”

“…They were combined to calculate the risk estimates (OR 0 ). All of the 19 studies (Arvind et al 2004;Biere-Rafi et al 2011;Chang et al 2010;Garcia Rodriguez et al 2008;Hosie et al 1996;Huerta et al 2005;Jick 2000;Lafrance and Miller 2012;Lapeyre-Mestre et al 2013;Layton et al 2003a, b;Mangoni et al 2010a, b;Schneider et al 2006;Shi et al 2004;Singh et al 2004;van Staa et al 2008;Varga et al 2013;Winkelmayer et al 2008) included in our review were adjusted for common variables such as age, sex, comorbidities and concomitant medication, other variables were also recorded here as study characteristics (Tables 1 and 2).…”

Content Analysis of Single-dose Analgesics Dispensed by Attendants in Retail Drug Outlets in Obiaruku ,Delta State , Nigeria : A Surrogate-type Approach

“…[17] The concomitant use of more than one NSAID has no therapeutic benefits rather, increases the profile of toxicities on the Central Nervous System (CNS) hematologic, renal, and hepatic and respiratory systems. [22][23][24][25][26] Morethan half of shop attendants, 63.2% routinely included Prednisolone 5mg in the single dose combo. This is of serious concern as the risk of gastrointestinal erosion and hemorrhage increases even further with the concomitant use of NSAIDs and corticosteroids.…”

Use of aceclofenac (airtal) in nonspecific back pain and other diseases

“…[18]. Оценено 38 502 серьезных побоч-ных эффекта со стороны ЖКТ, печени, почек, кожных по-кровов и сердечно-сосудистой системы.…”