News
Sickle cell drug is withdrawn over safety concerns just months after rollout
BMJ 2024; 387 doi: https://doi.org/10.1136/bmj.q2147 (Published01 October 2024)Cite this as: BMJ 2024;387:q2147
1. Elisabeth Mahase
Author affiliations
The sickle cell treatment voxelotor (Oxbryta) has been withdrawn from all markets by the manufacturer Pfizer after a “higher than anticipated” number of deaths were reported and clinical evidence showed that the drug’s benefits no longer outweighed the risks.
In a recall notice issued on 30 September the UK Medicines and Healthcare Products Regulatory Agency told clinicians and patients that “emerging data” suggestedan “unfavourable imbalance in vaso-occlusive crises (acute painful crises) andfatal events (deaths)” in patients treated with the drug.1
The agency shared a letter from Pfizer with UK healthcare professionals, which said that all patients currently having voxelotor prescribed must be contacted …
Prof Joseph Ana
Lead Senior Fellow/ medicalconsultant.
Center for Clinical Governance Research &
Patient Safety (ACCGR&PS) @ HRI GLOBAL
P: +234 (0) 8063600642
E: info@hri-global.org
8 Amaku Street, State Housing, Calabar,Nigeria.
www.hri-global.org
HIFA Profile: Joseph Ana is the Lead Senior Fellow/Medical Consultant at the Centre for Clinical Governance Research and Patient Safety (CCGR&PS) with Headquarters in Calabar, Nigeria, established by HRI Global (former HRIWA). He is the Country Coordinator for PACK Nigeria (Practical Approach to Care Kit) which is specifically designed to improve clinical competence (improving accuracy of diagnosis and treatment) in primary health care. He is also a Member of the World Health Organisation’s Technical Advisory Group on Integrated Care in primary, emergency, operative, and critical care (TAG-IC2). As the Cross River State Commissioner for Health (2004-2008), Joseph Ana led the introduction of the evidence based, homegrown quality tool, the 12-Pillar Clinical Governance Programme (12-PCGP) in Nigeria, which also suitable for lower-, low-, and middle income countries (LLMIC) with similar weak health sector and system. To ensure sustainability of 12-PCGP, the ‘Department of Clinical Governance, Servicom & e-health’ was established in Cross River State Ministry of Health in 2007. His main interest is in ‘Whole health sector and system strengthening in LLMICs’. He has written six books on the 12-Pillar Clinical Governance Programme, including the TOOLS manual for its Implementation, currently in its 2nd Edition. He served as Chairman of the Nigerian Medical Association’s Standing Committee on Clinical Governance (2012-2022), and he won the Association’s ‘Award of Excellence’ on three consecutive occasions for the innovation of 12-PCGP in Nigeria. He served as Chairman, Quality & Performance subcommittee of the Technical Working Group for the implementation of the Nigeria Health Act 2014. He was Member, National Tertiary Health Institutions Standards Committee (NTISC) of the Federal Ministry of Health, 2017-2022. He is the pioneer Secretary General/Trustee-Director of the Charity, NMF (Nigerian Medical Forum UK) which took the BMJ to West Africa in 1995. Joseph is a member of the HIFA Steering Group; the HIFA working group on Community Health Workers, and the Working Group on HIFA-WHO Collaboration (http://www.hifa.org/support/members/joseph-0 http://www.hifa.org/people/steering-group). Email: info AT hri-global.org and jneana AT yahoo.co.uk