E-drug: ADRs and cox 2 inhibitors (cont)
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In response to Jody Dalmacion's query regarding rofecoxib / Vioxx(c):
You report a case of pulmonary hemorrhage and possible Henoch
Schonlein purpura after administration of rofecoxib. While there have
been no reports of untoward bleeding after cox2-inhibitor treatment
in Sweden (as far as I know), the Medical Product Agency recently
issued a warning of acute renal insufficiency after rofecoxib
therapy. This report can be found on
http://www.mpa.se/lakemedel/ie_lakeindex.html (in Swedish). In brief,
seven cases of acute renal insufficiency have occurred, three in
women and four in men, aged 63 to 92 years. The patients took usual
doses of rofecoxib, ie 12,5-25 mgs daily. All seven cases were judged
to be severe by the Agency: two patients died and five recovered, the
latter having suffered only reversible renal failure. All patients
but one had decreased kidney function prior to taking the drug. Four
were also treated for congestive heart failure with frusemide,
ACE-inhibitors/AII-blockers and/or digoxin. One was
dehydrated.
The conclusion of the Agency is that the risk of adverse kidney
effects of cox2-inhibitors are similar to that of old-fashioned
NSAID's, and that having a creatinin clearance of less than 30 ml/min
is a contraindication for treatment with rofecoxib.
In the case you described, were there any signs of kidney affection?
Best regards,
Staffan Svensson
staffan.svensson@pharm.gu.se
Dept of Clinical Pharmacology
Sahlgrenska Hospital
Gothenburg, Sweden
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