Jul-Sep, 2012 - Indian Journal of Pharmacy Practice

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Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaA Possible Case of Filgrastim-Induced Death1 1 2 2 3Pawar V * , Krishna S.N , Narayana G. , Sadiq J and Thomas D1Pharm. D Intern, Department of Pharmacy Practice, Raghavendra Institute of Pharmaceutical Education & Research, Anantapur, AndhraPradesh2Assistant Professor, Department of Pharmacy Practice, Raghavendra Institute of Pharmaceutical Education & Research, Anantapur, AndhraPradesh3Head of Department of Pharmacy Practice, Raghavendra Institute of Pharmaceutical Education & Research, Anantapur, Andhra PradeshA B S T R A C TSubmitted: 21/07/2012Accepted: 31/07/2012This is a case report focusing on a 50 year old woman's death possibly due to Filgrastim. Filgrastim is considered to be a drug of choice inneutropenic cases. But in this case, Filgrastim has developed several severe Adverse Drug Reactions resulting into the death of patient.Naranjo's Causality Assessment Algorithm was used to assess the cause of death & the algorithm indicated Filgrastim as a possible cause ofdeath.Keywords: Filgrastim, Filgrastim-Induced Death, Drug-Induced Neutropenia & Granulocyte-Colony Stimulating FactorINTRODUCTIONCommercially available Granulocyte-Colony StimulatingFactor (G-CSF) preparations have significantly improved thequality of life (QoL) of patients with neutropenia1internationally. This report summarizes the development ofsore throat, breathlessness (dyspnoea), tachycardia &wheezing sound in chest associated with the use of Filgrastimwhich finally lead to patient's death.CASE REPORTA 50 year old woman was admitted in one of a private hospitalin Maharashtra, with following chief complaints;Ÿ Diffused scaly lesions over the exterior surface of rightforearm,Ÿ Similar kind of lesions over the sun-exposed areas of face& lips &Ÿ Black colored discoloration of skin.On local examination, the skin of patient was observed to bedry over the lesions with presence of extensive scaling &patient was unable to open her mouth freely due to presence ofsub-mucosal fibrosis (due to betel nuts chewing habit) overbuccal region. On the basis of this data, a preliminary/provisional diagnosis was done as exposure dermatitis & drugAddress for Correspondence:Vinay Gorakhnath Pawar, PharmD Intern ,B-2/112, Niligiri Building, AtmaramNagar, Lokgram Complex, Netivali Road, Kalyan (East), Dist. Thane – 421306.MaharashtraE-mail: vinaypharmd@gmail.comhypersensitivity. The past medical & medication history ofpatient was asthma since 18 years & unknown anti-asthmaticmedications. Patient was not having any past medical historyof cancer. Clinical laboratory tests (hematological tests) werecarried out, which revealed that there was a gradual decrease3in the neutrophil count (21.2%) & total count (500cells/mm )& increase in the Erythrocyte Sedimentation Rate (98mm/hr).A final diagnosis was then done as Drug-induced neutropeniaon the basis of these clinical laboratory values. Identificationof drug/s which induced neutropenia was not done. A 300 mcgprefilled syringe of Filgrastim was administeredsubcutaneously once daily, for 4 days to treat drug-inducedneutropenia. Other drugs like ceftriaxone, amikacin, liquidparaffin lotion, and chlorhexidine mouthwash were alsogiven to treat lesions & sub-mucosal fibrosis respectively.On very next day (day 2) of the treatment, patient startedcomplaining of having sore throat, throat pain & fever. On day3, she developed breathlessness (dyspnoea), tachycardia &drowsiness along with continuing sore throat & throat pain.On examining lungs, wheezing sounds from the chest wereheard. On day 4, patient's daughter reported patient'srestlessness which on observation was found to be severeseizure attacks with froth coming out of her mouth followedby cardiac arrest. On examination, she was found to beunconscious, her pulse was not palpating, pupils were notdilated & not reacting to light, no heartbeats & no breathingsounds were heard. Cardio-Pulmonary Resuscitation (CPR)was tried on the patient by starting chest compressions withambu-bag (at the rate of 30:2 breaths) to save her life. CPRwas given for around 20-25 minutes (6 times). Along withIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 79
Pawar V - A Possible Case of Filgrastim-Induced DeathCPR, Intravenous (IV) bolus injections of atropine – 1mg/ml(10 ampoules) & adrenaline – 1mg/ml (2 ampoules) were alsogiven. In spite of all the above resuscitation methodsaccording to Advanced Cardiac/Cardiovascular Life Support2, 3(ACLS) protocols, the patient couldn't survive & was beenmedically declared as dead.DISCUSSIONIn this case, drug-induced neutropenia was diagnosed &treated on the basis of clinical laboratory investigations otherthan Absolute Neutrophil Count (ANC) which is a main key4for diagnosing neutropenia. Furthermore the patient wastreated with Filgrastim without identifying the drug/s thatcaused neutropenia. Filgrastim is considered to be a drug of1, 5choice in neutropenic cases. But in this case, developmentof sore throat, breathlessness (dyspnoea), tachycardia &wheezing sound in chest may be triggered due to Filgrastim,as because sore throat is observed as an Adverse DrugReaction (ADR) or an undesirable effect in some of therandomized clinical trials conducted on Filgrastim & theother effects (dyspnoea, tachycardia & wheeze) are givenunder the “WARNING” column of Filgrastim as serious6-8allergic reactions. Secondly, as the patient had a pastmedical history of asthma, more care was to be taken inprescribing Filgrastim to the patient because of the possibilityof these systemic allergic-like reactions. In one of arandomized, open-labelled, multicenter study, patients withsevere allergic history (seasonal/recurrent asthma) wereexcluded (kept in exclusion criteria) from their study due to9these reasons. Taking all these information underconsideration, a causality assessment of death was done by10using Naranjo's Causality Assessment Algorithm & thealgorithm indicated Filgrastim as a possible cause of deathwith Naranjo score = 3.CONCLUSIONThis case report accentuates the importance of collectingcomplete data of patient's history such as; past medicalhistory, past medication history, current clinical laboratorytests, etc. before initiating any treatment. Also monitoring,reporting & management of ADRs are necessary in order toavoid such types of severe events.ACKNOWLEDGMENTWe would like to declare that there is no conflict of interest ofany of the authors of this article.REFERENCES1. Dale D.C., Bolyard A.A., Schwinzer B.G., et al., The SevereChronic Neutropenia International Registry: 10-year Follow-upReport. Supportive Cancer Therapy 2005;3(4):220-31.2. Neumar R.W., Otto C.W., Link M.S., et al., Adult AdvancedCardiovascular Life Support : 2010 American HeartCardiovascular Care Association Guidelines forCardiopulmonary Resuscitation and EmergencyCardiovascular Care. Circulation 2010; 122:S729-S767.3. Varon J., Fromm R.E. & Vallejo-Manzur F., Advanced CardiacLife Support Algorithms: Changes and Current American HeartAssociation Recommendations. Hospital Physician 2002;35-46.4. Provan D., Singer C.R.J., Baglin T. & Lilleyman J., OxfordndHandbook of Clinical Haematology, Oxford University Press. 2edition 2004;16,136.5. Hassan B.A.R., Yusoff Z.B.M. & Othman S.B., Filgrastim andantibiotics treatment reduces neutropenia severity in solidcancer patients. Asian Pacific J Cancer Prev. 2009;10:641-4.6. Clinical Pharmacology, Filgrastim, Available at:https://www.clinicalpharmacology.com//Forms/Monograph/monograph.aspx?cpnum=246&sec=monadve&h=647973706e6561 (Assessed on 16/07/2011).7. Package insert. Neupogen (Filgrastim). Thousand Oaks,California: Amgen Manufacturing, Limited, Inc., March 2010.8. Package insert. Nugraf (Filgrastim). Shameerpet, Hyderabad,Andhra Pradesh: Zenotech Laboratories Limited, VersionCF/01-06.9. Thierry F., Jean-Luc H., Frederic M., et al. Stem Cell Factor inCombination With Filgrastim After Chemotherapy ImprovesPeripheral Blood Progenitor Cell Yield and Reduces ApheresisRequirements in Multiple Myeloma Patients: A Randomized,Controlled Trial. Blood 1999;94(4):1218-1225.10. Naranjo C.A., Busto U., Seliers E.M., et al., (1981), A Method forEstimating the Probability of Adverse Drug Reactions, Clin.Pharmacol. Ther. 1981;30(2):239-245.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 80
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