Back Matter - The Journal of Bone & Joint Surgery

Are safety considerations limiting your use of ibuprofen?
It’s time to set the story straight
Take a closer look before your next OTC analgesic recommendation
Data and messages around OTC analgesics continue to evolve, and, therefore, treatment paradigms must evolve
as well. Take another look, and you may find that some communications are not telling the full story. When
considering which OTC analgesic to recommend, it is important to periodically review all the evidence on risks
and benefits as the data set continues to grow.
OTC ibuprofen may be right for more patients than you think*
• Clinical studies have shown when OTC ibuprofen
is taken as directed by the label for no longer
than 10 days, there is a very low increased risk
of stomach complaints or bleeding 1-4
• In a study by Moore et al, GI tolerability of
OTC ibuprofen was at least as favorable as
acetaminophen during 7-day therapy 5
• Studies have demonstrated that higher doses
of ibuprofen are associated with a greater risk
of GI side effects (odds ratio 4.6) vs lower
(OTC) doses (odds ratio 1.1) 1,6
• Naproxen and OTC ibuprofen have the
most favorable cardiovascular risk profile
among widely used Rx and OTC NSAIDs 7
• For patients already on, or for whom you
are considering initiating a cardioprotective
aspirin regimen:
– Taking ibuprofen at least ½ hour after the
dosing of immediate-release low-dose
aspirin is a practical method to minimize
potential impairment of the antiplatelet
effect of aspirin 8,9
– Because the effect of aspirin taken
daily on platelets is long lasting, the
occasional use of ibuprofen poses
a minimal risk of attenuating the
antiplatelet effect of low-dose aspirin 9
• Overall, OTC ibuprofen has a low risk
factor for developing acute or chronic
renal conditions 1,10,11
• NSAIDs, including ibuprofen, demonstrate an
increased risk of causing renal impairment
at high (Rx) doses, especially among elderly
patients or patients with reduced renal function 12
• OTC ibuprofen has a very low risk factor for
developing liver injury, especially compared
to the severe liver damage observed with
acetaminophen overdose and the occasional
liver reaction from aspirin 1,2
• A large-scale review article concluded that,
when compared with all analgesics, OTC
ibuprofen is less toxic in serious overdose
situations and is rarely associated with deaths
from either accidental or intentional overdose
(or with serious adverse events) 1
* Remind patients to use OTC analgesics as directed.
Nothing is more effective than Advil ® for acute pain. †13-17 Rethink Relief. Think Advil ® .
†
Among leading OTC pain relievers/fever reducers.
To get a closer look at the clinical evidence and the Advil ® label, please visit us at www.AdvilAide.com.
We invite you to explore the latest data on ibuprofen in regard to GI tolerability; cardiovascular, renal,
and hepatic safety; as well as toxicity. What you fi nd may surprise you.
References: 1. Rainsford KD. Ibuprofen: pharmacology, effi cacy, and safety. Infl ammopharmacology. 2009;17(6):275-342. 2. Rainsford KD, Roberts C, Brown S. Ibuprofen and
paracetamol: relative safety in non-prescription dosages. J Pharm Pharmacol. 1997;49:365-376. 3. Kellstein DE, Waksman JA, Furey SA, Binstok G, Cooper SA. The safety profi le of
nonprescription ibuprofen in multiple-dose use: a meta-analysis. J Clin Pharmacol. 1999;39:520-532. 4. Bjarnason I. Ibuprofen and gastrointestinal safety: a dose-duration-dependent
phenomenon. J R Soc Med. 2007;100(suppl 48):11-14. 5. Moore N, Van Ganse E, Le Parc J-M, et al. The PAIN study: paracetamol, aspirin and ibuprofen new tolerability study. Clin
Drug Invest. 1999;18(2):89-98. 6. Lewis SC, Langman MJS, Laporte J-R, Matthews JNS, Rawlins MD, Wiholm B-E. Dose-response relationships between individual nonaspirin
nonsteroidal anti-infl ammatory drugs (NANSAIDs) and serious upper gastrointestinal bleeding: a meta-analysis based on individual patient data. Br J Clin Pharmacol. 2002;54(3):320-326.
7. McGettigan P, Henry D. Cardiovascular risk with non-steroidal anti-infl ammatory drugs: systematic review of population-based controlled observational studies. PLoS Med.
2011;8(9):1-18. doi:10.1371/journal.pmed.1001098. 8. Cryer B, Berlin RG, Cooper SA, Hsu C, Wason S. Double-blind, randomized, parallel, placebo-controlled study of ibuprofen
effects on thromboxane B 2 concentrations in aspirin-treated healthy adult volunteers. Clin Ther. 2005;27(2):185-191. 9. Food and Drug Administration science paper: concomitant
use of ibuprofen and aspirin: potential for attenuation of the anti-platelet effect of aspirin. Food and Drug Administration Web site. http://www.fda.gov/downloads/Drugs/DrugSafety/
PostmarketDrugSafetyInformationforPatientsandProviders/UCM161282.pdf. Published September 8, 2006. Accessed June 6, 2012.10. Whelton A. Renal effects of over-the-counter
analgesics. J Clin Pharmacol. 1995;35:454-463. 11. Furey SA, Vargas R, McMahon FG. Renovascular effects of nonprescription ibuprofen in elderly hypertensive patients with mild renal
impairment. Pharmacotherapy. 1993;13(2):143-148. 12. Kean WF, Rainsford KD, Kean IRL. Management of chronic musculoskeletal pain in the elderly: opinions on oral medication use.
Infl ammopharmacology. 2008;16:53-75. 13. Data on fi le. Pfi zer Consumer Healthcare. 14. Bradley JD, Brandt KD, Katz BP, Kalasinski LA, Ryan SI. Comparison of an antiinfl ammatory
dose of ibuprofen, an analgesic dose of ibuprofen, and acetaminophen in the treatment of patients with osteoarthritis of the knee. N Engl J Med. 1991;325:87-91. 15. Dalton JD Jr,
Schweinle JE. Randomized controlled noninferiority trial to compare extended release acetaminophen and ibuprofen for the treatment of ankle sprains. Ann Emerg Med. 2006;48:
615-623. 16. Boureau F, Schneid H, Zeghari N, Wall R, Bourgeois P. The IPSO study: ibuprofen, paracetamol study in osteoarthritis: a randomised comparative clinical study comparing
the effi cacy and safety of ibuprofen and paracetamol analgesic treatment of osteoarthritis of the knee or hip. Ann Rheum Dis.2004;63:1028-1034. 17. Schiff M, Minic M. Comparison of
the analgesic effi cacy and safety of nonprescription doses of naproxen sodium and ibuprofen in the treatment of osteoarthritis of the knee. J Rheumatol. 2004;31:1373-1383.
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