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5PSQ-022 Drug-induced aplastic anaemia: an analysis of the FDA adverse event reporting system (FAERS)
  1. F Pappalardo1,
  2. MA D’agata1,
  3. MA Khaleel2,
  4. A Hayat Khan2,
  5. SM Sheikh Ghadzi2
  1. 1Catania Local Health Authority, Department of Pharmacy, Catania, Italy
  2. 2Universiti Sains Malaysia, Discipline of Clinical Pharmacy- School of Pharmaceutical Sciences, Pulau Pinang, Malaysia


Background and Importance Aplastic anaemia (AA) is a rare condition resulting from a deficit in hematopoietic stem and progenitor cells, characterised by a huge social and economic burden. AA is included in the Designated Medical Event (DME) list developed by the European Medicines Agency (EMA), which contains medical conditions that are inherently serious and often medicine-related.

Aim and Objectives In this analysis, we aimed to shed light on the most frequent aplastic anaemia associated drugs in real-life by mining the FDA Adverse Event Reporting System (FAERS). FAERS is one of the largest spontaneous reporting databases in the world, used to perform signal detection in pharmacovigilance.

Material and Methods A disproportionality analysis of the FAERS was conducted by analysing the Individual Case Safety Reports (ICSRs) from the first quarter of 2004 (2004 Q1) to the third quarter of 2021 (2021 Q3). The reporting odds ratio (ROR) with a relevant 95% confidence interval (95% CI) as a disproportional measure was calculated. The ROR was considered statistically significant when the lower limit of the 95% CI of the ROR exceeded 1, with at least three cases reported (N≥3).

Results Overall, during the examined period (2004 Q1–2021 Q3), on a total of N=11.631.635 reports, N=3.413 ICSRs containing the preferred term ‘aplastic anaemia’ were retrieved. AA affected people with a median age of 49.62 (±25.08) years, mostly female (N=1.645, 54.9%). According to the ROR value, ferrous phosphate 594.82 (95% CI 184.68–1.915,80), sucrose 98.86 (95% CI 36.89–264.90), aminopyrine 82.04 (95% CI 26.32–255.76), levosimendan 81.41 (95% CI 54.90–120.73) and methenolone 81.41 (95% CI 54.90–120.73) were associated with disproportionate reporting, resulting in a potential signal. Regarding the number of ICSRs, the most frequent AA-associated drugs on FAERS were eculizumab N=431, lymphocyte immune globulin, anti-thymocyte globulin N=228, eltrombopag N=204, pentamidine N=77 and ethosuximide N=28.

Conclusion and Relevance Knowing the drugs associated with aplastic anaemia is essential for promoting appropriate use of them and improving patient safety during therapy. Furthermore, healthcare professionals should be aware of the necessity of strictly monitoring patients treated with these drugs and promptly recognising signs and symptoms of drug-associated AA. Further investigations are required to confirm if these drugs play a role in the development of AA.

Conflict of Interest No conflict of interest.

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