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Pediatric Lead Chelation Managed During Critical Medication Shortages: Case Report and Literature Review
Mahi K Singh1, Jason M Kane1,2, Sana J Said3
1Department of Pediatrics (MKS, JMK), University of Chicago and Comer Children's Hospital, Chicago, IL.
Insights
A national shortage of lead chelation therapy (edetate calcium disodium) complicated a severe pediatric case. This highlights the urgent need for advocacy and policy changes to prevent future medication shortages for essential antidotes.
Area of Science:
- Pediatric Toxicology
- Environmental Health
- Neurodevelopmental Disorders
Background:
- Lead poisoning in children causes severe neurodevelopmental issues and shows socioeconomic disparities.
- A critical national shortage of edetate calcium disodium (CaNa2 EDTA), a primary FDA-approved lead chelation therapy, has emerged.
- This case underscores the vulnerability of pediatric patients during medication supply chain disruptions.
Purpose of the Study:
- To present a case of severe symptomatic lead poisoning in a child during a CaNa2 EDTA shortage.
- To emphasize the critical need for advocacy concerning medication shortages, particularly for antidote therapies.
- To call for policy initiatives addressing the national stockpile of chelation agents.
Main Methods:
- A 23-month-old child with severe lead poisoning (initial blood lead level 364 mcg/dL) was treated.
- Initial therapy involved continuous infusion of CaNa2 EDTA and intramuscular dimercaprol.
- Due to CaNa2 EDTA shortage on day 3, therapy transitioned to enteral succimer monotherapy.
Main Results:
- Parenteral therapy for 72 hours reduced blood lead levels from 364 mcg/dL to 72 mcg/dL.
- Despite initial treatment and environmental mitigation, elevated blood lead levels persisted.
- The child required three additional courses of enteral succimer and still has detectable levels 2 years later.
Conclusions:
- Clinicians must develop and study alternative chelation regimens for pediatric lead toxicity in the context of medication shortages.
- Public policy initiatives, such as establishing a national stockpile of chelation agents, are essential.
- Minimizing supply chain disruptions is crucial to ensure adequate and equitable antidote therapy for lead poisoning.
Abstract:
Lead poisoning in children has the potential for devastating neurodevelopmental consequences. There is significant socioeconomic disparity in children with lead poisoning. Specific lead chelation regimens have been approved for children by the US Food and Drug Administration, however in the United States, there has been a recent national shortage of the primary therapy, edetate calcium disodium (CaNa2 EDTA). This case report presents a 23-month-old child with severe symptomatic lead poisoning during a national shortage of CaNa2 EDTA to highlight the need for advocacy regarding critical medication shortages, especially for antidote therapy. The infant's initial blood lead level was 364 mcg/dL and he received a continuous infusion of CaNa2 EDTA (1000 mg/m2/day), as well as dimercaprol (4 mg/kg intramuscularly every 4 hours). The supply of CaNa2 EDTA was exhausted on day 3 of therapy so he was transitioned to enteral succimer monotherapy. Initial parenteral therapy of 72 hours achieved a lead level of 72 mcg/dL; he then completed his enteral course of succimer along with environmental mitigation. However, elevated blood lead levels persisted and he subsequently required 3 more courses of enteral succimer, and he continues to have detectable blood lead levels 2 years after initial presentation. In the face of medication shortages including CaNa2 EDTA, and now also dimercaprol, clinicians must create and study alternative chelation therapy regimens for pediatric lead toxicity. Furthermore, public policy initiatives, including the development of a national supply stockpile of chelation agents, must be created in order to minimize supply chain disruption and ensure adequate and equitable antidote therapy for lead poisoning outbreaks.
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