The Society of Gynaecology and Obstetrics of Nigeria (SOGON) has called on the Federal Government to accelerate the approval and nationwide integration of Ferric Carboxymaltose (FCM), an intravenous iron treatment, as part of efforts to address maternal anaemia and reduce preventable pregnancy-related deaths.
SOGON President, Prof. Okechukwu Ikpeze, made the appeal during a stakeholders’ roundtable in Abuja focused on developing policy and implementation strategies for the adoption of FCM within Nigeria’s healthcare system.
Ikpeze described anaemia during pregnancy as one of the country’s most pressing maternal health challenges, noting that available evidence shows that more than half of women attending antenatal clinics are affected.
He said expanding access to effective treatment options such as FCM could play a significant role in improving maternal and newborn outcomes, particularly among women with severe anaemia.
“The government is already aware of the effectiveness and safety of FCM. Our appeal is for the relevant authorities to complete the necessary approval processes and integrate the drug into Nigeria’s healthcare system,” he said.
The SOGON president added that the organisation would continue to provide scientific evidence and technical support to assist government efforts aimed at making the treatment available across the country.
According to Ikpeze, maternal anaemia increases the risk of complications during pregnancy and childbirth, placing both mothers and babies at greater risk. He explained that FCM offers a faster and more effective way of correcting iron deficiency compared with traditional oral iron therapy, especially in cases involving severe anaemia.
Evidence Supports Safety and Effectiveness of FCM
The stakeholders’ meeting brought together representatives from the Federal Ministry of Health and Social Welfare, the National Agency for Food and Drug Administration and Control (NAFDAC), development partners, researchers and academics to discuss pathways for introducing the drug into routine maternal healthcare.
Citing research conducted by the Centre for Translation and Implementation Research at the University of Lagos Teaching Hospital and the Centre for Applied Research and Implementation in Maternal and Child Health across Lagos, Kano and Kaduna states, Ikpeze said studies had demonstrated the effectiveness of FCM without significant safety concerns.
“The evidence is very strong. Hundreds, if not thousands, of pregnant women have received the drug, and no deaths were linked to its use,” he said.
He noted that findings from the studies had been published in international journals and that FCM had been introduced in several countries, including Malawi, as part of efforts to improve maternal health outcomes.
Ikpeze emphasized that the treatment was particularly beneficial for women with severe anaemia, as it can replenish iron levels more quickly and effectively than oral iron supplements, which may take longer to produce results and are sometimes poorly tolerated.
Funding and Access Remain Key Challenges
While highlighting the benefits of FCM, Ikpeze acknowledged that affordability remains one of the major barriers to widespread access, particularly because many Nigerians still pay directly for healthcare services.
He explained that the drug was initially costly due to import expenses associated with research and early availability but had become more affordable as access and supply expanded.
He called for the inclusion of FCM in the National Health Insurance Authority’s benefit package, arguing that government support and funding would significantly improve access for pregnant women.
“If government adopts and funds the programme, affordability will no longer be a major barrier,” he said.
Government Signals Support for Maternal Health Innovation
Speaking on behalf of the Coordinating Minister of Health and Social Welfare, Prof. Muhammad Ali Pate, the National Lead of the Maternal and Newborn Mortality Reduction Innovation Initiative, Dr Dayo Adeyanju, said the Federal Government remained committed to supporting interventions designed to reduce maternal and child deaths.
Adeyanju said the ministry’s reform priorities include improving health system governance, strengthening healthcare delivery for women and children, and promoting local production of essential health commodities.
“We are here to see how we can support the entire coordination process, from procurement and distribution to last-mile delivery, while ensuring this intervention is incorporated into our procurement system,” he said.
He added that effective integration of new health interventions would require coordination across procurement, supply chains, healthcare facilities and regulatory institutions.
NAFDAC Highlights Need for Safety Monitoring
The Director-General of NAFDAC, Prof. Mojisola Adeyeye, represented by the agency’s Director of Pharmacovigilance, Mukosolu Nzekwe, stressed the importance of strong safety monitoring systems as FCM moves toward broader adoption.
She said continuous post-marketing surveillance would be necessary to track the drug’s performance and ensure that safety standards remain a priority after wider deployment.
Adeyeye also warned that any plans for local production of FCM would undergo strict regulatory assessment to guarantee quality and compliance with national and international standards.
“We are now a World Health Organization-listed regulatory authority, and the manufacture of medicines comes with very strict regulatory requirements. If you are planning to manufacture this product locally, NAFDAC will be watching every step of the process very closely,” she said.
Stakeholders at the meeting agreed that improving access to effective treatments for maternal anaemia would require collaboration between government agencies, healthcare providers, researchers and development partners.
With maternal mortality remaining a major public health concern in Nigeria, advocates believe the timely adoption of interventions such as Ferric Carboxymaltose could contribute significantly to protecting mothers and newborns.