farmacovigilancia8(ing) 04/07/28 15:05 Page 1
farmacovigilancia8(ing) 04/07/28 15:05 page 1
1st quarter 2004
arthritis rheum. 2001 jun;45(3):209-15.
editor’s notes • watson dj, harper se, z*** pl, quan h, bolognese ja, simon tj. gastroin-
testinal tolerability of the selective cyclooxygenase-2 (cox-2) inhibitor rofe-
coxib compared with nonselective cox-1 and cox-2 inhibitors in
the summaries of two studies of general interest conducted by osteoarthritis. arch intern med. 2000 oct 23;160(19):2998-3003.
the infarmed pharmacovigilance department adverse drug
reactions sector are included in this issue. finally, the association between pulmonary interstitial disease
and leflunomide, as well as between prolonged qt interval
the first paper gives a glimpse into the initially shy but rapidly and quinolones, are briefly discussed. in both cases, one is
growing dynamics of adr reporting by both community and dealing with serious but apparently very rare adrs.
hospital pharmacists. it was presented at the 32nd european
symposium on clinical pharmacy (valencia, october, 2003).
the second paper is a descriptive study on reported adverse
what do they stand for?!
reactions to cox-2 inhibitors, and was awarded a prize for best
poster presentation in the field of pharmaceutical records and adr adverse drug reaction
regulations at the national pharmacists’ congress (lisbon, cpmp european committee of proprietary medicinal products
november 2003). although interestingly raising the issue of emea european medicines evaluation agency
adverse reaction patterns of coxibs and of nsaids in general, il information leaflet
its methodological design does not allow for any assumptions ma marketing authorization
to be made on possible differences in safety profiles. for the spc summary of the product’s characteristics
sake of example, amongst other sources of bias, one has only
to remind oneself that the proportion of reported adrs to a
recently marketed product with potential for widespread use
will probably be much higher than that for long established
how can i report an
medicines whose well-known adrs are not surprising anymore,
thus tending to be und***eported. keeping up with the litera-
ture on the subject is essential for an opinion on this complex yellow (physicians), purple (pharmacists) or white (nurses) postage paid
subject. below a few interesting references can be found for an card
initial approach and reflection: infarmed’s pharmacovigilance department
tel: 217 987 140 - fax: 217 987 155
e-mail: [email protected]
• brune k, hinz b. selective cyclooxygenase-2 inhibitors: similarities and dif-
ferences. scand j rheumatol. 2004;33(1):1-6. northern regional pharmacovigilance unit
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