Govt urged to fast-track approval of anaemia drug for expectant mums

The Society of Gynaecology and Obstetrics of Nigeria (SOGON) has urged the Federal Government to expedite approval and integration of Ferric Carboxymaltose (FCM) into Nigeria’s healthcare system to tackle maternal anaemia and reduce pregnancy-related deaths. SOGON President, Prof. Okechukwu Ikpeze, made the call at a stakeholders’ roundtable on the drug’s policy and implementation, held in Abuja. Ikpeze described anaemia in pregnancy as one of Nigeria’s leading maternal health challenges, noting that more than half of women attending antenatal clinics are affected. He said government was aware of the drug’s safety and effectiveness and appealed for the approval process to be concluded. “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. He added that SOGON would continue providing scientific evidence to support government efforts to make the treatment available nationwide. Ikpeze said anaemia raises the risk of death from pregnancy or childbirth complications and endangers unborn and newborn babies. He said FCM corrects anaemia effectively and could help reduce maternal mortality. Read Also: Tinubu tasks communications team to deepen public engagement as economy improves, security coordination strengthens The roundtable brought together officials of 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 develop a roadmap for the drug’s adoption. Citing studies 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 FCM corrects anaemia without serious adverse effects. “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. Related News SOGON, FIGO advocate adoption of new anaemia medication to reduce maternal deaths Lagos, SOGON to reduce maternal deaths SOGON seeks FG's collaboration to curb infant mortality He said the findings had been published in international journals and that the drug had also been deployed in Malawi and other countries. [Note: original said “several developed countries” — flag: Malawi is not typically classified as developed; verify wording.] He described FCM as more effective than oral iron therapy for women with severe anaemia. On cost, Ikpeze said the drug was initially expensive due to import costs for research but had become cheaper with wider availability. He identified out-of-pocket spending as a major access barrier and called for FCM’s inclusion in the National Health Insurance Authority’s benefit package. “If government adopts and funds the programme, affordability will no longer be a major barrier,” he said. Speaking for 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 innovative interventions to reduce maternal and child deaths. He said the ministry’s reform agenda prioritised improved governance, better health outcomes for women and children, and stronger local production of 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. NAFDAC Director-General, Prof. Mojisola Adeyeye, represented by the agency’s Director of Pharmacovigilance, Mukosolu Nzekwe, said robust post-marketing surveillance would be critical as the drug moves towards wider use, adding that continuous monitoring would ensure safety after adoption. She said NAFDAC would subject any local production plan to strict regulatory scrutiny for quality compliance. “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. --> --> TAGS: SOGON