Maternal Mortality: SOGON Urges FG to approve Anemia Drug for pregnant Women
By Ojoma Akor
The Society of Gynecology and Obstetrics of Nigeria (SOGON) has called on the Federal Government of Nigeria to expedite the approval and integration of Ferric Carboxymaltose (FCM) into Nigeria’s healthcare system.
SOGON President Prof. Okechukwu Ikpeze made the call during a stakeholders’ roundtable on strengthening policy and implementation for Ferric Carboxymaltose in Abuja, Nigeria.
He said the medicine is a proven intervention that could significantly reduce maternal deaths linked to anemia in pregnancy.
He explained that maternal anemia remains one of Nigeria’s most pressing public health challenges, affecting more than half of women attending antenatal clinics.
He said anemia substantially increases the risk of maternal death when pregnancy or childbirth complications occur and also endangers the health and survival of unborn and newborn babies.
He said that Ferric Carboxymaltose could transform treatment for pregnancy-related anemia as government and regulators weigh nationwide adoption.
He said, “The government is already aware of the effectiveness and safety of Ferric Carboxymaltose. Our appeal is for the relevant authorities to complete the necessary approval processes and integrate the drug into Nigeria’s healthcare system.
“As a professional body, we will continue to provide scientific evidence and support the government at every stage to ensure this life-saving treatment becomes available to pregnant women across the country.”
Prof. Ikpeze highlighted that the drug has demonstrated superior effectiveness in treating moderate-to-severe anemia during pregnancy compared with conventional oral iron therapy, making it a critical intervention in efforts to reduce Nigeria’s high maternal mortality burden.
He explained that the policy dialogue convened officials from the Federal Ministry of Health and Social Welfare and the National Agency for Food and Drug Administration and Control (NAFDAC), as well as researchers, academics, development partners, and other stakeholders, to develop a roadmap for the drug’s adoption.
“Our ultimate goal is to reduce maternal deaths and improve outcomes for both mothers and their babies,” he said.
Prof. Ikpeze further said evidence generated through studies conducted by the Center for Translation and Implementation Research at the University of Lagos Teaching Hospital (LUTH) and the Center for Applied Research and Implementation in Maternal and Child Health (CAPRIMAN) across Lagos, Kano and Kaduna states showed that Ferric Carboxymaltose effectively corrected anemia without serious adverse effects.
“The evidence is very strong. Hundreds, if not thousands, of pregnant women have received the drug, and no deaths have been linked to its use,” he said.
He added that the findings have been published in reputable international scientific journals and noted that the medicine has also been successfully used in Malawi and several high-income countries.
While acknowledging that the medicine was initially expensive because it was imported primarily for research, Ikpeze said increased availability had begun to lower costs.
He, however, identified out-of-pocket healthcare spending as a major barrier to access and urged the government to include the drug in the National Health Insurance Authority (NHIA) benefits package.
“If government adopts and funds the program, affordability will no longer be a major barrier,” he said.
The Coordinating Minister of Health and Social Welfare, Prof. Muhammad Ali Pate, said the Federal Government remains committed to supporting innovative interventions that improve maternal and child health.
He said the Federal Government’s health sector reform agenda prioritizes improved governance, better health outcomes for women and children, and the strengthening of local production of essential health commodities.
Represented by the National Lead of the Maternal and Newborn Mortality Reduction Innovation Initiative (MAMII), Dr. Dayo Adeyanju, he said: “We are looking at how to support the entire process—from procurement and distribution to last-mile delivery—while ensuring this intervention becomes part of our national procurement system.”
Meanwhile, NAFDAC Director-General Prof. Mojisola Adeyeye, represented by the agency’s Director of Pharmacovigilance, Mukosolu Nzekwe, said robust post-marketing surveillance would be essential if the medicine receives national approval.
She said although available evidence supports the safety and effectiveness of Ferric Carboxymaltose, continuous monitoring would be necessary to detect and manage any adverse events once the medicine is deployed at scale.
Nzekwe also stressed that any plans for local manufacturing would be subject to rigorous regulatory oversight.
“We are now a World Health Organization-listed regulatory authority, and medicine manufacturing comes with strict regulatory requirements. If this product is manufactured locally, NAFDAC will closely monitor every stage of the process to ensure compliance with quality and safety standards,” she said.
Also speaking, SOGON Secretary-General Prof. Azubuke Onyebuchi described maternal mortality as unacceptable and reaffirmed the society’s commitment to promoting evidence-based interventions that improve maternal health outcomes.
“As custodians of women’s health in Nigeria, we cannot accept women dying while giving birth,” Onyebuchi said.
He noted that anemia contributes significantly to maternal illness and death and said Ferric Carboxymaltose offers an opportunity to improve treatment beyond reliance on blood transfusions.
According to him, anemia affects between 40 and 75 percent of pregnant women across different parts of Nigeria, with an estimated national average prevalence of about 50 percent.
He acknowledged that introducing the medicine nationwide would require regulatory approval, increased stakeholder awareness and wider availability.
“This is a new medicine, so we must follow the appropriate regulatory processes while ensuring healthcare providers and policymakers understand its potential to treat anemia effectively,” he said.
Health experts at the meeting said accelerating access to effective treatment for pregnancy-related anemia could play a significant role in reducing preventable maternal deaths and improving survival for mothers and newborns across Nigeria.