Incidence of spontaneous notifications of adverse reactions with aceclofenac, meloxicam, and rofecoxib during the first year after marketing in the United Kingdom

Abstract

Abstract:The objective was to compare the incidence of adverse reactions reported with three nonsteroidal anti-inflammatory drugs with different cyclo-oxygenase (COX)-2 selectivity. All spontaneous adverse reaction notifications in the pharmacovigilance database of the World Health Organisation Collaborating Centre for International Drug Monitoring with aceclofenac, meloxicam, and rofecoxib that were recorded during the first year of marketing were included. The incidence rate (adverse reactions/10 6 defined daily dose) and 95% confidence interval for total adverse reactions was 8.7 (6.1-12.0) for aceclofenac, 24.8 (23.1-26.6) for meloxicam, and 52.6 (49.9-55.4) for rofecoxib. Aceclofenac had a lower incidence of gastrointestinal bleeding, abdominal pain, and arterial hypertension than meloxicam and a lower incidence of gastrointestinal bleeding, abdominal pain, liver toxicity, thromboembolic cardiovascular events, arterial hypertension, and edema than rofecoxib. The incidence of total and gastrointestinal adverse reactions was significantly lower with aceclofenac than with meloxicam or rofecoxib, thus raising doubts about the hypothetical advantage of COX-2 selective inhibitors.

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

“…Actually, nimesulide was withdrawn from the Spanish and the Finnish markets in 2002 because of an unfavourable benefit-risk balance related to liver injuries [23][24][25]. In the present study, it was found that nimesulide and aceclofenac were associated with the highest risk of liver ADRs, followed by diclofenac and piroxicam, which is in agreement with the literature [6,7,26,27].…”

“…The last type of serious ADR investigated, thrombotic cardiovascular events, was very rarely reported to the French pharmacovigilance system, as in other systems [26].…”

Evaluation of the efficacy of bite wafer chewing in pain reduction in fixed orthodontic appliance treatment

“…The use of non-steroidal anti-inflammatory drugs (NSAIDs) is the most preferred method for pain control in orthodontics but the overuse of analgesics and their potential side effects particularly in children have raised a concern over their use (10). Experimental and clinical studies have shown that NSAIDs can delay or inhibit tooth movement by inhibiting periodontal inflammatory response.…”

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

“…В Великобритании в течение года изучали побоч-ные эффекты ацеклофенака по сравнению с таковыми ме-локсикама и рофекоксиба [17]. Частота побочных эффек-тов, рассчитанная на 1 млн суточных приемов препарата, составила 8,7 (6,1-12,0) для ацеклофенака и 24,8 (23,1-26,6) и 52,6 (49,9-55,4) для мелоксикама и рофекоксиба соответственно.…”

“…Наиболее часто отмечались кожные проявления, затем шли желудоч-но-кишечные, печеночные, почечные осложнения, сравни-тельно редко регистрировались сердечно-сосудистые нару-шения. Самой высокой была частота серьезных побочных эффектов со стороны ЖКТ при использовании кетопрофе-на, пироксикама и напроксена (6,87; 6,54 и 5,07 соответст-венно), со стороны печени при приеме нимесулида и ацек-лофенака (4,53 и 3,67 соответственно), со стороны кожных покровов при применении мелоксикама (3,15), со стороны почек при лечении теноксикамом (3,17). Таким образом, ацеклофенак (аэртал) широко ис-пользуется при неспецифической боли в спине и многих других заболеваниях.…”