WHO Drug Information Vol. 23, No. 1, 2009 - World Health ...

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WHO Drug Information Vol 23, No. 1, 2009Safety and Efficacy Issuescontinuous intra-articular infusion ofanaesthetics, particularly when epinephrineis also used, is not recommended.The association between postoperativepain pumps and the development ofchondrolysis is difficult to identify. Indeed,chondrolysis may appear many monthsafter the use of a pain pump (3–5). Inaddition, confounders such as the concomitantuse of health products (e.g.,gentian violet, chlorhexidine, bone cement)and radiofrequency devices maybe responsible for causing chondrolysisafter shoulder surgery (5–10).Health care professionals are encouragedto follow the instructions for use andrefrain from using postoperative painpumps for continuous intra-articularinfusion of local anaesthetics, particularlywith epinephrine, after shoulder surgery(1, 2).Extracted from the Canadian AdverseReactions Newsletter, Volume 19 ,Number 1 (2009).References1. On-Q PainBuster [Canadian instructions foruse]. Lake Forest (CA): I-Flow Corporation;2008.2. Donjoy Pain Control Device [Canadianinstructions for use]. Huntington Beach (CA):Curlin Medical Inc; 2007.3. Hansen BP, Beck CL, Beck EP, et al.Postarthroscopic glenohumeral chondrolysis.Am J Sports Med 2007;35(10):1628–34.4. Yarbrough R, Gross R. Chondrolysis: anupdate. J Pediatr Orthop 2005;25(5):702–4.5. Petty DH, Jazrawi LM, Estrada LS, et al.Glenohumeral chondrolysis after shoulderarthroscopy: case reports and review of theliterature. Am J Sports Med 2004;32(2):509–15.6. Shibata Y, Midorikawa K, Koga T, et al.Chondrolysis of the glenohumeral jointfollowing a color test using gentian violet.Int Orthop 2001;25(6):401–3.7. van Huyssteen AL, Bracey DJ. Chlorhexidineand chondrolysis in the knee. J BoneJoint Surg Br 1999;81(6):995–6.8. Leclair A, Gangi A, Lacaze F, et al. Rapidchondrolysis after an intra-articular leak ofbone cement in treatment of a benign acetabularsubchondral cyst: an unusual complicationof percutaneous injection of acryliccement. Skeletal Radiol 2000;29(5): 275–8.9. Jerosch J, Aldawoudy AM. Chondrolysis ofthe glenohumeral joint following arthroscopiccapsular release for adhesive capsulitis: acase report. Knee Surg Sports TraumatolArthrosc 2007;15(3):292–4.10. Ciccone WJ II, Weinstein DM, Elias JJ.Glenohumeral chondrolysis following thermalcapsulorrhaphy. Orthopedics 2007;30(2):158–60.Atomoxetine: seriousliver injuryUnited States of America — The Foodand Drug Administration (FDA) continuesto receive reports of serious liver injury inpatients given atomoxetine. Atomoxetinereceived FDA approval on 26 November2002 as the first non-stimulant medicationused for the treatment of attention deficithyperactivity disorder (ADHD) in children(aged 6 years and above) and adults (1).Atomoxetine’s therapeutic action isbelieved to be due to its selective inhibitionof norepinephrine reuptake. From theyear 2002 to 2007, approximately 3.3million patients received a prescription foratomoxetine in the United States. Ofthose, approximately 2.1 million patients(64%) were children aged 17 years andyounger (2).While a signal for serious liver injury wasnot detected during premarket clinicaltrials of atomoxetine, two published postmarketingreports did identify instances ofatomoxetine-induced hepatitis (3, 4). Inone of these reports, there was a positiverechallenge with atomoxetine. Subse-27
Safety and Efficacy IssuesWHO Drug Information Vol 23, No. 1, 2009quent to these reports, a bolded warningwas added in 2004 to the atomoxetinelabel indicating an increased risk forsevere liver injury.Since the 2004 labelling change, FDAhas received six additional reports ofserious liver injury in patients takingatomoxetine. Following an evaluation ofthe information from the drug sponsorand additional literature articles submittedto FDA, the atomoxetine product labelwas again revised in 2007. The warningsand precautions section of the drug labeladvises prescribers about the risk forsevere liver injury with this drug (1).Post-marketing reports indicate thatatomoxetine is associated with seriousidiosyncratic liver injury. Some of thecases reported additional confoundingfactors, such as occasional acetaminophenuse. Some of the cases lackedsufficient clinical detail to convincinglydetail the relationship between the use ofatomoxetine and liver injury. The mechanismof atomoxetine-induced liver injuryremains unknown.FDA encourages physicians to:• Inform patients to immediately contacttheir physician at the first sign or symptomof fatigue, loss of appetite, nausea,vomiting, pruritus, dark urine, jaundiceof the sclerae or skin, right upperquadrant tenderness, or unexplained“flu–like” symptoms.• Determine liver enzyme levels when apatient presents with signs or symptomsof liver injury.• Discontinue and not resume atomoxetinetreatment if patients present withjaundice or laboratory evidence of liverinjuryReferences1. Atomoxetine (Strattera®) product labelling.http://www.fda.gov/cder/foi/label/2008/021411s024s025s026lbl.pdf2. Bangs ME, Ling J, Zhang S, et al. Hepaticevents associated with atomoxetine treatmentfor attention deficit hyperactivity disorder. DrugSafety. 2008;31(4): 345–54.3. Stojanovski SD, Casavant MJ, Hayat MM,et al. Atomoxetine-induced hepatitis in a child.Clin Toxicol (Phila). 2007;45 (1):51–5.4. Lim JR, Faught PR, Chalasani NP. Severeliver injury after initiating therapy with atomoxetinein two children. J Pediatr. 2006;148(6):831–4.Drotrecogin alfa:ongoing safety reviewUnited States of America — The Foodand Drug Administration (FDA) is awareof a retrospective study (1) which hasreported an increased risk of seriousbleeding events and death in patientswith sepsis (a severe illness related to abloodstream infection) and baselinebleeding risk factors who receiveddrotrecogin alfa. Drotrecogin alfa (activated)(Xigris®) is a recombinant humanactivated protein C indicated for thereduction of mortality in adult patientswith severe sepsis who have a high riskof death (2). The baseline bleeding riskfactors as defined by this study are thesame as those described in the drotrecoginalfa prescribing information.An editorial (3) accompanying the articlestated that one approach to increasingthe safety of drotrecogin alfa would be tonot administer it to any patients withsepsis and baseline bleeding risk factors,effectively changing a warning in theproduct labelling to a contraindication.Under FDA regulations, contraindicationsin the prescribing information describesituations where the risks are known (thatis, are not theoretical) and where the risksof use clearly outweigh any possiblebenefit.The study was a retrospective medicalrecord review of 73 patients who receiveddrotrecogin alfa. Serious bleeding events28
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