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

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Safety and Efficacy IssuesWHO Drug Information Vol. 25, No. 2, 2011Tumour necrosis factorblockers: hepatosplenicT-cell lymphomaUnited States of America — The Foodand Drug Administration (FDA) continuesto receive reports of hepatosplenic T-Celllymphoma (HSTCL), primarily in adolescentsand young adults being treated forCrohn disease and ulcerative colitis withmedicines known as tumour necrosisfactor (TNF) blockers, as well as withazathioprine, and/or mercaptopurine.Crohn disease and ulcerative colitiscause inflammation of the digestivesystem. Common symptoms are pain inthe abdomen, cramps, and diarrhoea.Bleeding from the rectum, weight loss,joint pain, skin problems and fever alsomay occur. Children with the disease mayhave growth problems, develop intestinalblockage and experience malnutrition.FDA believes the risks and benefits ofusing TNF blockers, azathioprine, and/ormercaptopurine should be carefullyweighed when prescribing these drugs tochildren and young adults, especially forthe treatment of Crohn disease andulcerative colitis.The product labels for infliximab(Remicade®) and adalimumab (Humira®)have been updated and the productlabels for azathioprine and mercaptopurineare being updated to include warningsabout HSTCL that have been reportedin patients treated with theseproducts.Reference: FDA Drug Safety Communication,14 April 2011 at http://www.fda.gov/Drugs/DrugSafetyDipeptidyl peptidase-4inhibitors: possible glycaemiccomplicationsJapan — The Ministry of Health, Labourand Welfare (MHLW) has warned aboutthe risk of hypoglycaemia associatedwith concomitant use of dipeptidyl peptidase-4(DPP-4) inhibitors and sulfonylureas,and the risk of diabetic ketoacidosisand hyperglycaemia afterswitching from insulin to glucagon-likepeptide-1 (GLP-1) receptor agonists.DPP-4 inhibitors and GLP-1 receptoragonists are antidiabetic drugs whichinactivate incretin. Incretin is a gastrointestinalhormone which stimulatesinsulin secretion. DPP-4 inhibitors areused to treat type 2 diabetes mellitus byincreasing the endogenous active incretinlevel and thereby controlling bloodglucose. As of December 2010, sitagliptinphosphate hydrate, vildagliptin, andalogliptin benzoate have been approvedin Japan.GLP-1 receptor agonists are used to treattype 2 diabetes mellitus by binding to theGLP-1 receptor to promote insulin secretionin response to the increase in bloodglucose. As of December 2010, liraglutide(genetic recombination) and exenatidehave been approved.Reference: Pharmaceuticals and MedicalDevices Safety Information, No.275. December2010 at http://www.pmda.go.jp/englishLenalidomide: risk ofnew malignanciesUnited States of America — The Foodand Drug Administration (FDA) hasprovided information on clinical trials thatfound that patients treated with lenalidomide(Revlimid®) may be at increasedrisk of developing new types of cancercompared to patients who did not take thedrug.FDA is currently reviewing all availableinformation on this potential risk andrecommends that patients continuelenalidomide treatment as prescribed bytheir physician. The benefits and the risks106
WHO Drug Information Vol. 25, No. 2, 2011Safety and Efficacy Issuesshould be carefully weighed when prescribingthis drug. Lenalidomide is usedto treat myelodysplastic syndrome and isused along with other drugs to treatpeople with multiple myeloma.Preliminary data derived from evaluationof outcomes after longer-term exposureto lenalidomide and from controlledclinical trials conducted inside and outsidethe Unites States shows an increasedincidence of some secondprimary malignancies, particularly acutemyelogenous leukemia (AMaL) and B-celllymphoma malignancies when comparedto controls. Since lenalidomide is ananalogue of thalidomide, FDA is alsocurrently reviewing all available informationon this potential risk for thalidomide.Reference: FDA Drug Safety Communication,8 April 2011 at http://www.fda.gov/Drugs/DrugSafetyPneumovax 23®:injection site reactionsAustralia — The Therapeutic GoodsAdministration (TGA) is advising healthprofessionals not to administer a secondor subsequent dose of Pneumovax 23®vaccine pending the outcome of a reviewof an apparent increased rate of injectionsite reactions following administration ofthe second dose.Pneumovax 23® vaccination is used toprevent life threatening bacterial infectionsfor anyone who is at high risk ofpneumococcal infections.Pneumovax 23® vaccine is known to beassociated with a high rate of localinjection site reactions which can includesevere injection site reactions such ascellulitis and abscess. There is varyingevidence from published trials as towhether injection site reactions are morecommon following revaccination.The Australian Technical Advisory Groupon Immunization (ATAGI) is currentlyreviewing the place of Pneumovax 23®in the National Immunization Programme.This alert is not applicable to use of the7-valent pneumococcal conjugate vaccinePrevenar® or the 10-valent pneumococcalconjugate vaccine, Synflorix®, whichare given to babies.Reference: Therapeutic Goods AdministrationSafety Alert. 18 April 2011. http://www.tga.gov.au/safety/alerts-medicine-pneumovax-110416.htmDabigatran etexilate mesylatecapsules: storage and handlingUnited States of America — The Foodand Drug Administration (FDA) is alertingthe public to important storage andhandling requirements for dabigatranetexilate mesylate (Pradaxa®) capsules.Due to the potential for product breakdownfrom moisture and loss of potency,Pradaxa® capsules should only bedispensed and stored in the original bottleor blister package. However, manyconsumers use pill boxes or pill organizersto aid them in remembering to taketheir medications.Although the current Pradaxa® labelstates that the product should be discarded30 days after the original bottle isopened, data currently under review bythe FDA indicate that the product maintainsits potency up to 60 days after bottleopening as long as it is stored in theoriginal bottle and the handling requirementsare met — including that the cap isclosed tightly after use and the bottle iskept away from excessive moisture, heatand cold. Pradaxa® capsules will hydrolyseover time when exposed to humidity,causing a breakdown of active ingredientand rendering the medication less effective.Reference: FDA Drug Safety Communication,29 March 2011 at http://www.fda.gov/Drugs/DrugSafety107
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WHO Drug Information Vol. 25, No. 2, 2011

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