Analysis of Spontaneous Reports Provided by Russian Physicians Regarding Adverse Reactions Occurring after Administration of Nimesulide: Hepatotoxic Complications Occur Very Rarely
Non-steroid anti-inflammatory drugs (NSAID) are the main drugs for relieving acute pain and management of chronic pain. Among them, nimesulide is highly popular in Russia. The main advantage of the drug is considered to be a relatively low risk of adverse reactions (AR). However, rate of serious complications occurring after administration of nimesulide in a real-life clinical practice was examined in very few domestic studies. Study objective. To assess rate and character of complications upon administration of nimesulide based on spontaneous reports about ARs. Materials and methods. To analyze all spontaneous reports regarding ARs related to administration of the most popular generic of nimesulide (Nise®, Dr. Reddy's) received by the Federal Service on Surveillance in Healthcare and Social Development of Russian Federation (Roszdravnadzor) during 2009-2014 period of time. Results. Within a six-year period of time, Roszdravnadzor received 138 spontaneous reports regarding ARs related to administration of Nise. Mainly, they described cutaneous allergic reactions (50.7%) and GI-tract complications (23.9%). Hepatic ARs were noted only in five patients. By taking into consideration that during this observation period 104,200,000 packages of Nise were sold in Russia, rate of ARs is considered to be very low: less than one case per 150,000 therapeutic courses for total ARs and less than one case per 1,000,000 patients. Conclusion. Serious ARs such as severe hepatotoxic reactions occur very rarely after administration of Nise.