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

WHO Drug Information Vol. 24, No. 4, 2010Safety and Efficacy IssuesA case of fatal anaphylaxis has beenreported in a patient with rheumatoidarthritis treated with tocilizumab. NoCanadian cases of anaphylactic reactionhave been reported.As hypersensitivity reactions can occurwith the administration of tocilizumab,patients need to be closely monitoredthroughout the infusion for signs andsymptoms of hypersensitivity.If a hypersensitivity reaction is suspected,infusion is to be stopped immediately andappropriate treatment should be administered.Reference: Communication from Hoffmann-La Roche Limited, dated 13 September 2010at http://www.hc-sc.gc.ca/Pioglitazone: potentialbladder cancerUnited States of America — The Foodand Drug Administration (FDA) is reviewingdata from an ongoing, ten-yearepidemiological study designed to evaluatewhether pioglitazone (Actos®), isassociated with an increased risk ofbladder cancer. Findings from studies inanimals and humans suggest this is apotential safety risk that needs furtherstudy. Pioglitazone is used in adults withtype 2 diabetes mellitus.Bladder cancer is estimated to occur in20 per 100 000 persons per year in theUnited States and is thought to be higherin diabetics.FDA has not concluded that pioglitazoneincreases the risk of bladder cancer. TheAgency is reviewing information related tothe safety concern and will update thepublic when additional information isavailable.Reference: FDA Drug Safety Communication,17 September 2010 at http://www/fda.govAngiotensin receptor blockersand cancer: safety reviewUnited States of America — The Foodand Drug Administration (FDA) is conductinga review of the class of medicationsknown as angiotensin receptorblockers (ARBs) after a recently publishedstudy suggested they may beassociated with a small increased risk ofcancer.ARBs are used in patients with high bloodpressure and other conditions. Brandnames include Atacand®, Avapro®,Benicar®, Cozaar®, Diovan®, Micardis®,and Teveten®. ARBs are also sold incombination with other medications.The Agency plans to review the availabledata on these medications, and evaluateadditional ways to better assess a possiblelink between use of ARBs and cancer.FDA will update the public when thisreview is complete.References1. Sipahi I, Debanne SM, Rowland DY, SimonDI, Fang JC. Angiotensin-receptor blockadeand risk of cancer: meta-analysis ofrandomised controlled trials. The LancetOncology 2010;11(7), 627-36.2. FDA Drug Safety Communication, 15 July2010 at http://www/fda.govGnRH agonists, diabetes andcardiovascular diseaseUnited States of America — The Foodand Drug Administration (FDA) hasnotified the manufacturers of gonadotropin-releasinghormone (GnRH) agonistsof the need to add new safety informationto the Warnings and Precautions sectionof drug labels. This new informationwarns about increased risk of diabetesand certain cardiovascular diseases(heart attack, sudden cardiac death,stroke) in men receiving these medica-301