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

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Safety and Efficacy IssuesWHO Drug Information Vol. 25, No. 2, 2011Proton pump inhibitors:low magnesium levelsUnited States of America — The Foodand Drug Administration (FDA) is informingthe public that prescription protonpump inhibitor (PPI) drugs may causehypomagnesaemia if taken for prolongedperiods of time (in most cases, longerthan one year). In approximately onequarterof the cases reviewed, magnesiumsupplementation alone did notimprove low serum magnesium levelsand the PPI had to be discontinued.PPIs are used to treat gastroesophagealreflux disease (GERD), stomach andsmall intestine ulcers, and inflammation ofthe esophagus.Prescription PPIs include esomeprazolemagnesium, dexlansoprazole, omeprazole,lansoprazole, pantoprazolesodium, and abeprazole sodium.Reference: FDA Drug Safety Communication,2 March 2011 at http://www.fda.gov/Drugs/DrugSafetySeasonal influenza vaccinesAustralia — During the 2010 influenzaseason, an excess number of cases offebrile reactions and febrile convulsionswere observed in paediatric populationsfollowing immunization with one of theregistered seasonal trivalent influenzavaccines. Consequently, the TherapeuticGoods Administration (TGA) has imposeda condition on the registration of all 2011seasonal influenza vaccines with apaediatric indication which were notsupplied in Australia in 2010. Sponsorsare required to undertake active surveillanceof children from six months to nineyears of age to ensure effective monitoringof paediatric populations in Australiapreviously unexposed to these vaccines.Two sponsors were unable to meet thiscondition of registration. Although thesafety of Agrippal® and Fluarix ®hasbeen demonstrated in the northernhemisphere 2010/2011 influenza season,the TGA does not have any safety dataon the use of these vaccines in Australianchildren. Hence, the TGA recommendsthat these vaccines are not used in anychild under the age of nine years.For children under the age of nine years itis recommended that they be vaccinatedwith either Influvac® or Vaxigrip®. Thesetwo vaccines were not associated withincreased rates of fever or febrile reactionsin 2010.Reference: Therapeutic Goods AdministrationSafety Advisory, 11 March 2011. http://www.tga.gov.au/safetyIpilimumab: severe immunemediatedreactionsUnited States of America — The Foodand Drug Administration (FDA) hasposted information from the manufacturerof Ipilimumab (Yervoy®) about the riskevaluation and mitigation strategy(REMS) developed to ensure that thebenefits of ipilimumab outweigh the risksof severe and fatal immune-mediatedadverse reactions.Ipilimumab was approved in March 2011with a boxed warning stating that use ofthe product can result in severe and fatalimmune-mediated adverse reactions dueto T-cell activation and proliferation.These immune-mediated reactions mayinvolve any organ system. However, themost common severe immune-mediatedadverse reactions are enterocolitis,hepatitis, dermatitis (including toxicepidermal necrolysis), neuropathy, andendocrinopathy. The majority of theseimmune-mediated reactions initiallymanifested during treatment. However, aminority occurred weeks to months afterdiscontinuation.Reference: FDA Medwatch Communication,Dear Healthcare Professional Letter, 6 April2011 at http://www.fda.gov/Drugs/DrugSafety108
WHO Drug Information Vol. 25, No. 2, 2011Safety and Efficacy IssuesFluticasone propionate:risk of osteonecrosisCanada — Health Canada has receivedfive reports of osteonecrosis suspectedof being associated with fluticasonepropionate.The potential for osteonecrosis with highdoses of inhaled corticosteroids has beensuggested in the literature. Becausecorticosteroid-induced osteonecrosistends to occur in younger patients andtreatment options for advanced diseaseare limited, early identification is important.Fluticasone propionate is a highly potentglucocorticoid anti-inflammatory steroid.In Canada, it is available as an aqueousnasal spray, an inhalation aerosol, apowder for inhalation and a topical cream(1–3). Steroid-induced osteonecrosis, oravascular necrosis, is characterized bybone cell death resulting from compromizedblood supply. Corticosteroids,administered orally or parenterally, havebeen associated with osteonecrosis (4).Osteonecrosis related to inhaled ortopical use of steroids has also beenreported but the oral or parenteral use ofsteroids was a confounding factor (4).The potential for osteonecrosis with highdoses of inhaled corticosteroids, such asin the treatment of severe persistentasthma or eosinophilic oesophagitis, hasbeen suggested (4).Systemic adverse reactions may occurwith intranasal and inhaled use of corticosteroids(1, 2). The long-term effects offluticasone propionate are still unknown.The relative determinants of systemicadverse reactions to inhaled and intranasalcorticosteroids have been assessedand fluticasone propionate was determinedto have a high systemic potency(5). Because corticosteroid-inducedosteonecrosis tends to occur in youngerpatients (the average age at onset is 33)and treatment options for advanceddisease are limited, early identification isimportant (4).Extracted from the Canadian AdverseReaction Newsletter, Volume 21(2), April2011 at http://www.healthcanada.gc.caReferences1. Flovent HFA, Flovent Diskus® (fluticasonepropionate) [product monograph]. Mississauga(ON): GlaxoSmithKline Inc.; 2010.2. Flonase® (fluticasone propionate) [productmonograph]. Mississauga (ON):GlaxoSmithKline Inc.; 2004.3. Advair Diskus (salmeterol xinafoate/fluticasone propionate) [product monograph].Mississauga (ON): GlaxoSmithKline Inc.;2008.4. Powell C, Chang C, Naguwa S, et al.Steroid induced osteonecrosis: an analysis ofsteroid dosing risk. Autoimmun Rev2010;9(11):721–43.5. Lipworth BJ, Jackson CM. Safety ofinhaled and intranasal corticosteroids. DrugSaf 2000;23(1):11–33.Varenicline: hyperglycaemiain patients with diabetesCanada — Health Canada has received18 reports of hyperglycaemia suspectedof being associated with varenicline(Champix®) in patients with type 1 andtype 2 diabetes.Varenicline is indicated for smokingcessationtreatment in adults in conjunctionwith smoking-cessation counselling.The current Canadian product monographlists diabetes mellitus and hypoglycaemiaunder “less common clinical trialadverse drug reactions” and describesthese adverse reactions (ARs) as infrequentand rare, respectively.Diabetes mellitus is a chronic metabolicdisorder characterized by the presence ofhyperglycaemia and consequently is a109
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WHO Drug Information Vol. 25, No. 2, 2011

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