A record number of fatalities in many categories of patients treated with deferasirox: Loopholes in regulatory and marketing procedures undermine patient safety and misguide public funds?

Expert Opinion on Drug Safety

Volumn 12, Issue 5, 2013, Pages 605-609

  Kontoghiorghes, George J ^a  

^a Postgraduate Research Institute   (Cyprus)

Author keywords

Chelation therapy; Deferasirox; Deferiprone; Deferoxamine; Drug safety; Ethics; Non iron loaded diseases; Thalassaemia; Toxicity and fatalities; Transfusional iron overload

Indexed keywords

DEFERASIROX; DEFERIPRONE; DEFEROXAMINE; IRON; BENZOIC ACID DERIVATIVE; IRON CHELATING AGENT; TRIAZOLE DERIVATIVE;

CARDIOVASCULAR DISEASE; CHELATION THERAPY; DRUG CONTROL; DRUG COST; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG FATALITY; DRUG INDUSTRY; DRUG MARKETING; DRUG MONITORING; DRUG SAFETY; DRUG USE; FOOD AND DRUG ADMINISTRATION; HEMOCHROMATOSIS; HUMAN; IRON CHELATION; IRON OVERLOAD; IRON STORAGE; LEUKEMIA; MYELODYSPLASTIC SYNDROME; NEOPLASM; NEUROLOGIC DISEASE; PATIENT SAFETY; POSTMARKETING SURVEILLANCE; RECOMMENDED DRUG DOSE; REVIEW; SICKLE CELL ANEMIA; THALASSEMIA;

BENZOATES; HUMANS; IRON CHELATING AGENTS; PATIENT SAFETY; TRIAZOLES; DEFEROXAMINE; IRON OVERLOAD; MARKETING; PYRIDONES; THALASSEMIA;

EID: 84882948015     PISSN: 14740338     EISSN: 1744764X     Source Type: Journal    
DOI: 10.1517/14740338.2013.799664     Document Type: Review

References (15)

1. Kontoghiorghes GJ. Deferasirox: uncertain future following renal failure fatalities, agranulocytosis and other toxicities. Expert Opin Drug Saf 2007;6:235-9
2. Kontoghiorghes GJ. Transparency and access to full information for the fatal or serious toxicity risks, low efficacy and high price of deferasirox, could increase the prospect of improved iron chelation therapy worldwide. Hemoglobin 2008;32:608-15
3. Kontoghiorghes GJ. Introduction of higher doses of deferasirox: better efficacy but not effective iron removal from the heart and increased risks of serious toxicities. Expert Opin Drug Saf 2010;9:233-41
4. Boelaert JR, Fenves AZ, Coburn JW. Deferoxamine therapy and mucormycosis in dialysis patients: report of an international registry. Am J Kidney Dis 1991;18:660-7
5. Exjade (deferasirox) tablets for oral suspension. Highlights of prescribing information. Novartis Pharmaceutical Corp, USA (T2011-106); 2011. p. 1-16
6. Cohen AR. Iron chelation therapy: you gotta have heart. Blood 2010;115:2333-4
7. Anonymous. Fatal adverse drug events. ISMP Medicat Saf Alert 2010;15(12):1-3
8. Pocock N. CHMP finalises review of deaths associated with deferasirox (Exjade-) in the US and updates to the SPC. Reference: October 2009 Plenary meeting monthly report Source: EMEA. 2009. Available from: http://www.nelm. nhs.uk
9. Schwartz A. 2010. FDA reports. Exjade. 2474 reported reactions/deaths. Available from: http://www.fda-reports.com/exjade/reaction/death/page1.html
10. Anonymous. eHealthMe - Real World Drug Outcomes. 2012. Available from: http://www.ehealthme.com/q/exjade-side-effects-drug-interactions
11. Kolnagou A, Kleanthous M, Kontoghiorghes GJ. Reduction of body iron stores to normal range levels in thalassaemia by using a deferiprone/ deferoxamine combination and their maintenance thereafter by deferiprone monotherapy. Eur J Haematol 2010;85:430-8
12. Farmaki K, Tzoumari I, Pappa C, et al. Normalisation of total body iron load with very intensive combined chelation reverses cardiac and endocrine complications of thalassaemia major. Br J Haematol 2010;148:466-75
13. Tefler P, Goen PG, Christou S, et al. Survival of medically treated thalassaemia patients in Cyprus. trends and risk factors over the period 1980 - 2004. Haematologica 2006;91:1187-92
14. Angelucci E, Barosi G, Camaschella C, et al. Italian Society of Hematol practice guidelines for the management of iron overload in thalassemia major and related disorders. Haematologica 2008;93:741-52
15. Meerpohl JJ, Antes G, Rucker G, et al. Deferasirox for managing iron overload in people with thalassaemia. Cochrane Database Syst Rev 2012;2:CD007476