WHO Drug Information Vol. 25, No. 2, 2011

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WHO Drug Information Vol. 25, No. 2, 2011Safety and Efficacy IssuesSafety trials for long actingbeta-agonistsUnited States of America — To furtherevaluate the safety of long acting betaagonists(LABAs) when used in combinationwith inhaled corticosteroids for thetreatment of asthma, the Food and DrugAdministration (FDA) is requiring manufacturersto conduct five randomized,double-blind, controlled clinical trialscomparing the addition of LABAs toinhaled corticosteroids versus inhaledcorticosteroids alone.Four clinical trials will be conducted inadult and adolescent patients 12 yearsof age and older to evaluate:• Budesonide and formoterol.• Fluticasone and salmeterol.• Mometasone and formoterol.• Formoterol.One clinical trial will be conducted inpaediatric patients aged 4 to 11 years andwill include 6200 patients. Patients in alltrials will be treated for six months, andthe primary endpoint will be a compositeof serious asthma outcomes: asthmarelateddeath, intubation, or hospitalization.The paediatric trial will also assessother relevant quality of life endpointssuch as days of school missed andemergency room visits because ofasthma related illness.The clinical trials will begin in 2011 andFDA expects to receive results in 2017.Reference: FDA Drug Safety Communication,15 April 2011 at http://www.fda.gov/Drugs/DrugSafetyRotavirus vaccination: riskof intussusceptionAustralia — The Therapeutic GoodsAdministration (TGA) has undertaken aninvestigation of a possible associationbetween the use of the rotavirus vaccinesRotarix® and RotaTeq® and the occurrenceof a rare form of bowel obstructionknown as intussusception (IS). This is acondition caused by the telescoping ofone segment of the bowel into another. Itis estimated to occur each year in around80 per 100 000 children under 12 monthsof age, which represents approximately200 cases per year in Australia. The peakincidence is in infants 5–10 months ofage, with 80% of cases occurring before24 months of age. It is much more commonin males than females.IS was found to be a side effect of thefirst generation rotavirus vaccine,RotaShield®, that was available in theUnited States in 1998–1999 and wasestimated to cause IS in 10–20 of every100 000 doses given to infants. It wasvoluntarily withdrawn from the US marketin October 1999 (1, 2).RotaShield® was not used outside theUSA, however, as the historical incidenceof IS is 2.5 to 3 times higher in infants inAustralia than in the US, this would havetranslated to 25–60 cases of IS for every100 000 doses of RotaShield®.Subsequently, two new rotavirus vaccines,Rotarix® and RotaTeq® weredeveloped and both were tested in largestudies designed to explore whether therewas a risk of IS (3, 4). In Australia, twopost-marketing studies have been conductedto investigate whether the new104
WHO Drug Information Vol. 25, No. 2, 2011Safety and Efficacy Issuesrotavirus vaccines are associated with anincreased risk of IS. The first study wasconducted using two surveillance systems,the Paediatric Enhanced DiseaseSurveillance (PAEDS) and the AustralianPaediatric Surveillance Unit (APSU). Thisstudy found an apparent four-fold increasedrisk of IS in babies within oneweek of being given the first dose ofeither vaccine, compared with historicaldata on hospitalizations coded as IS, butno overall increase in overall rates of ISup to the age of nine months.Following this, a large self-controlled caseseries (SCCS) study using data on allhospitalized cases coded as IS wascommissioned by the TGA. This studyfound a statistically significant four-foldincrease in the occurrence of IS in thefirst 1–7 days following the first dose ofeither Rotarix® or RotaTeq® comparedwith other time periods after vaccinereceipt. This increase in risk translates toapproximately two additional cases of ISoccurring in every 100 000 first doses ofvaccine administered, or six additionalcases each year in children under 12months of age in Australia.The World Health Organization (WHO)and the Australian Technical AdvisoryGroup on Immunization (ATAGI) haverecommended the continued use ofrotavirus vaccine for infants.References1. Withdrawal of Rotavirus Vaccine Recommendation.MMWR 1999;48(3):1107.2. Murphy T, Gargiullo P, Massoudi M, NelsonD et al. Intussusception among infants givenan oral rotavirus vaccine. New EnglandJournal of Medicine 2001; 344(8):564–723. Ruiz-Palacios G, P rez-Schael I, VelazqueaF, H HA, Breuer T et al. Safety and efficacy ofan attenuated vaccine against severe rotavirusgastroenteritis. New England Journal ofMedicine 2006;354(1):11–22.4. Vesikari T, Matson D, Dennehy P, DammePV et al. Safety and efficacy of a pentavalenthuman-bovine (WC3) reassortant rotavirusvaccine. New England Journal of Medicine2006;354(1):23–33.5. Macartney KK, Porwal M, Dalton D, CrippsT et al. Decline in rotavirus hospitalisationsfollowing introduction of Australia’s nationalrotavirus immunisation programme. J PaediatrChild Health 2011; published online: 18 Jan2011 DOI: 10.1111/j.1440-1754.2010.01953.6. Lambert SB, Faux CE, Hall L, Birrell FA etal. Early evidence for direct and indirect effectsof the infant rotavirus vaccine program inQueensland. Med J Aust 2009; 191: 157–160.7. Haber P, Patel M, Izurieta H, Baggs J et al.Postlicensure monitoring of intussusceptionafter RotaTeq® vaccination in the UnitedStates, February 1, 2006, to September 25,2007. Pediatrics 2008;121(6):1206–12.8. Velazquez FR, Colindres R, Grajales C,Hernandez MT, Mercadillo MG, Torres FJ,Yolanda M Apolinar C, DeAntonio-Suarez R,Ortega E, Blum M, Breuer T, Verstraeten T.Postmarketing surveillance of intussusceptionfollowing mass introduction of the humanrotavirus vaccine in Mexico: an interimanalysis. Excellence in Paediatrics, London,December 2–4, 20109. World Health Organization, Global AdvisoryCommittee on Vaccine Safety. Statement onRotarix® and Rotateq® vaccines and intussusception.22 September 2010.10. Buttery JP, Danchin MH, Lee KJ, CarlinJB, McIntyre PB, Elliott EJ, Booy R, Bines JEfor the PAEDS/APSU Study Group. Intussusceptionfollowing rotavirus vaccine administration:post marketing surveillance in theNational Immunization Program in Australia.Vaccine, 2011. In Press.11. Tapiainen T, Bonhoeffer J, Heininger U.Evaluation of the Brighton Collaboration casedefinition of acute intussusception during activesurveillance. Vaccine 2006;24(9):1483–7.12. Galati JC, Harsley S, Richmond P, CarlinJB. The burden of rotavirus-related illnessamong young children on the Australian healthcare system. ANZ Journal of Public Health2006;30:416-421.105
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