WHO Drug Information Vol. 24, No. 4, 2010

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Safety and Efficacy IssuesWHO Drug Information Vol. 24, No. 4, 2010tantly treated with CYP2D6 enzymeinhibitors, concentrations of the tamoxifenmetabolites that most strongly bind to theoestrogen receptor may be reduced.Reference: Drug Safety Update, Volume 4,Issue 4 November 2010 at http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/index.htmZoledronic acid solution:renal dysfunctionCanada — The manufacturer ofzoledronic acid 5 mg/100 mL solution forintravenous infusion (Aclasta®) hasinformed healthcare professionals ofimportant safety information. As of 30April 2010, 265 spontaneous reports ofrenal impairment have been receivedfollowing administration of Aclasta®,corresponding to a reporting rate ofapproximately 20 cases per 100 000patient-years of exposure.The following precautions should betaken to minimize the risk of renal adversereactions.• Zoledronic acid should not be used inpatients with severe renal impairment.• Zoledronic acid should be used withcaution when concomitantly used withother drugs that could impact renalfunction.• Creatinine clearance should be calculatedbefore each treatment followed byperiodic monitoring of serum creatininein patients with risk factors. Transientincrease in serum creatinine may begreater in patients with underlyingimpaired renal function.• Patients should be appropriately hydrated,especially elderly patients andthose receiving diuretic therapy.• A single dose of Aclasta® should notexceed 5 mg and the duration of infusionshould be no less than 15 minutes.Reference: Communication from NovartisPharmaceuticals Canada Inc. dated 12October 2010 at http://www.hc-sc.gc.ca/304
WHO Drug Information Vol. 24, No. 4, 2010Regulatory Action and NewsInfluenza vaccines: 2011southern hemisphereWorld Health Organization — It isexpected that pandemic A(H1N1),A(H3N2) and B viruses will co-circulateand the following viruses are recommendedfor influenza vaccines for the2011 southern hemisphere influenzaseason:• an A/California/7/2009 (H1N1)-like virus.• an A/Perth/16/2009 (H3N2)-like virus.(A/Wisconsin/15/2009 and A/Victoria/210/2009 are A/Perth/16/2009-likeviruses.)• a B/Brisbane/60/2008-like virus.As in previous years, national or regionalcontrol authorities approve the compositionand formulation of vaccines used ineach country. National public healthauthorities are responsible for makingrecommendations regarding the useof the vaccine.Reference: Recommended viruses forinfluenza vaccines for use in the 2011 southernhemisphere influenza season. WeeklyEpidemiological Record, 85:401–402 (2010) athttp://www.who.int/werRosiglitazone-containingantidiabetes medicines:suspension of marketingauthorizationEuropean Union — The EuropeanMedicines Agency has recommendedsuspension of the marketing authorizationsfor the rosiglitazone-containing antidiabetesmedicines Avandia®, Avandamet®and Avaglim®.Patients who are currently taking thesemedicines should make an appointmentwith their doctor to discuss suitablealternative treatments. Patients areadvised not to stop their treatment withoutspeaking to their doctor.Doctors should stop prescribing rosiglitazone-containingmedicines. Patientstaking rosiglitazone-containing medicinesshould be reviewed in a timely manner toamend their treatment.The current review of rosiglitazone by theAgency’s Committee for Medicinal Productsfor Human Use (CHMP) was initiatedon 9 July 2010 following the availability ofnew studies questioning the cardiovascularsafety of the medicine.Since its first authorization, rosiglitazonehas been recognized to be associatedwith fluid retention and increased risk ofheart failure and its cardiovascular safetyhas always been kept under close review.Consequently, the use of rosiglitazonewas restricted to second-line treatmentand contraindicated in patients with heartfailure or a history of heart failure when itwas first granted a marketing authorizationas Avandia® in 2000.Data from clinical trials, observationalstudies and meta analyses of existingstudies that have become available overthe last three years have suggested apossibly increased risk of ischaemic heartdisease associated with the use ofrosiglitazone. Further restrictions on theuse of these medicines in patients withischaemic heart disease were introduced.The availability of recent studies hasadded to the knowledge about rosiglitazoneand overall, the accumulated data305
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WHO Drug Information Vol. 24, No. 4, 2010

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