Sulphasalazine and mesalazine: serious adverse reactions re-evaluated on the basis of suspected adverse reaction reports to the Committee on Safety of Medicines * Author's reply
2003; BMJ; Volume: 52; Issue: 10 Linguagem: Inglês
10.1136/gut.52.10.1530
ISSN1468-3288
Autores Tópico(s)Pharmaceutical Practices and Patient Outcomes
ResumoWe were interested to read the report by Ransford and Langman of their analysis of yellow card reports of suspected adverse drugs reactions for sulphasalazine and mesalazine ( Gut2002;51:536–9 [OpenUrl][1][Abstract/FREE Full Text][2] ). These reports, submitted to the Committee on Safety of Medicines, may provide useful flags to signal unrecognised hazards of drugs. However, as adverse reactions are not always recognised or reported to the regulatory authorities by physicians, these reports usually underestimate the frequency of any adverse drug reaction. Of greater importance, underreporting is usually not random but selective, which may introduce serious bias when comparing different drugs.1 Various examples have been described previously of drugs that showed substantive differences in reporting rates, which were not substantiated after further research.1 For this reason, it is recommended that, once there is a signal for a suspected adverse drug reaction, other sources of data are investigated.2 We recently initiated a study to quantify the risk of renal toxicity in patients taking aminosalicylate (5-ASA) drugs in the UK. The General Practice Research Database (GPRD) was used for this study, … [1]: {openurl}?query=rft.jtitle%253DGut%26rft.stitle%253DGut%26rft.issn%253D0017-5749%26rft.aulast%253DRansford%26rft.auinit1%253DR%2BA%2BJ%26rft.volume%253D51%26rft.issue%253D4%26rft.spage%253D536%26rft.epage%253D539%26rft.atitle%253DSulphasalazine%2Band%2Bmesalazine%253A%2Bserious%2Badverse%2Breactions%2Bre-evaluated%2Bon%2Bthe%2Bbasis%2Bof%2Bsuspected%2Badverse%2Breaction%2Breports%2Bto%2Bthe%2BCommittee%2Bon%2BSafety%2Bof%2BMedicines%26rft_id%253Dinfo%253Adoi%252F10.1136%252Fgut.51.4.536%26rft_id%253Dinfo%253Apmid%252F12235076%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [2]: /lookup/ijlink?linkType=ABST&journalCode=gutjnl&resid=51/4/536&atom=%2Fgutjnl%2F52%2F10%2F1530.atom
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