Australia. Parecoxib can cause renal impairment, with multiple doses associated with a greater risk, according to a report in the Australian Adverse Drug Reactions Bulletin. In Australia, parecoxib is only approved for a single perioperative dose for postoperative pain, due to concerns about the safety of multiple doses. To date, Australia's Adverse Drug Reactions Advisory Committee (ADRAC) has received 20 reports of parecoxib-associated adverse reactions, 13 of which involved renal impairment, including four cases of acute renal failure. In six of these cases, patients had received multiple doses of parecoxib, up to five, but the other seven had received only one dose. However, two of these seven patients had risk factors.

Reference:

Australian Adverse Drug Reactions Bulletin Vol. 23, No. 3, June 2004. Available on the Internet at www.tga.gov.au