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• W2000417305 abstract "K Weerasuriya (June 19, p 2161) 1Weerasuriya K Registration of new drugs in developing countries.Lancet. 1999; 353: 2161-2162Summary Full Text Full Text PDF PubMed Scopus (9) Google Scholar raises concerns about the registration process of new drugs in developing countries, and refers to nimesulide, a selective COX-2 inhibitor. This is emblematic, in developed countries, of the difficulties caused by the gap between evidence-based data on efficacy and indications for drug use in children. The recent suspension of paediatric nimesulide in Portugal and of the whole molecule in Israel, after reports of three fatal cases of hepatic failure in children,2Portugal suspends paediatric nimesulide.Scrip. 1999; 2431: 20Google Scholar illustrate how licensing decisions may differ from one country to another and for old drugs as well as new drugs. Nimesulide, an old drug with a Belgian patent dating back to 1974, was first marketed in Italy in 1985. In an attempt to clarify the profile of nimesulide use in children we have searched for drugs with antipyretic and analgesic properties marketed in Italy and labelled for use in children under 12 years. Seven molecules were retrieved and we compared their paediatric indications with those in three other European countries (table). Acetaminophen is the only drug with paediatric formulations available in all four countries. On account of its association with Reye's syndrome, aspirin is not recommended in the UK for use in children and the label always states “not to be used by children under 12 years old”. The use of metamizolo (dipyrone) is controversial even in adults and has been banned in several countries, but it can be used by Italian and German children. Ibuprofen, which is widely used elsewhere and whose documented risk/benefit profile is similar to acetaminophen,3McIntyre J Hull D Comparative efficacy and tolerability of ibuprofen and paracetamol in fever.Arch Dis Child. 1996; 74: 164-167Crossref PubMed Scopus (86) Google Scholar does not have paediatric formulations in Italy.TableDrugs with antipyretic and analgesic properties marketed by indication for use in childrenMoleculeItalyUKGermanyFranceAcetaminophenYesYesYesYesAcetylsalicylic acidYesNoYesYesMetamizoloYesN/MYes (>4 years)NoGuacetisalYesN/MN/MN/MImidazole salicylateYesN/MN/MN/MMorniflumateYesN/MN/MN/MNimesulideYesN/MN/MN/M(>6 years)N/M=not on market. Open table in a new tab N/M=not on market. Four molecules (nine formulations) have paediatric formulations available only in Italy. From Medline and Embase databases we were not able to find robust evidence on which to base the rational use of these drugs in children. Controlled trials with nimesulide were gathered in a monographic supplement of Drugs.4Bennett A Nimesulide: a multifactorial therapeutic approach to the inflammatory process? A 7 year clinical experience.Drugs. 1993; 46: xVGoogle Scholar Nevertheless, nimesulide is widely used in Italian children. An unpublished regional survey in Italy of 27 777 children followed by 34 general paediatric practitioners, showed that the prescription rate of nimesulide was 7·8 per 1000 children, compared with 125·6 per 1000 for acetaminophen. During the same period, monitoring the prescriptions for children in six urban pharmacies in Turin, sales of nimesulide were 1·9 per 1000 versus 70·7 per 1000 children for acetaminophen. Despite progress towards harmonising licensing processes by international agencies, on the national level systematic and continuous monitoring of drug use must continue. Transnational off-label drug use should be avoided by an efficient international postmarketing drug surveillance system, with the aim of guaranteeing the rational use of drugs, particularly for children, in developing and developed countries." @default.
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• W2000417305 date "1999-09-01" @default.
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• W2000417305 title "Use of nimesulide in children" @default.
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• W2000417305 doi "https://doi.org/10.1016/s0140-6736(05)76642-3" @default.
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