The LMHRA said the specific cause of the reaction could not be conclusively attributed to any one drug due to the mixture administered and the absence of further clinical testing.
Monrovia – The Liberia Medicines and Health Products Regulatory Authority (LMHRA) has responded to recent media reports surrounding the death of a 16-year-old boy at the St. Joseph’s Catholic Hospital earlier this year, providing clarity on its investigation and regulatory actions taken in the aftermath.
In a statement issued Wednesday through its Communications Manager Momoh B. Siryon, the LMHRA acknowledged the widespread public interest and media coverage of the January 2025 incident, while stressing that it does not typically address sensitive health issues in the press.
However, the agency said it found it necessary to address misinformation and explain its role in the matter.
According to the LMHRA, the incident triggered an independent investigation to determine the cause of the adverse drug reaction (ADR) that reportedly led to the teen’s death, assess the regulatory compliance of the medications involved, and recommend measures to prevent future occurrences.
Key Findings from the LMHRA Investigation
According to LMHRA, the patient was administered six medications, including Marcaine® Spinal Heavy (0.5%), an anesthesia drug containing Bupivacaine. ADRs of this nature, the LMHRA noted, are not uncommon in medical practice. The specific cause of the reaction could not be conclusively attributed to any one drug due to the mixture administered and the absence of further clinical testing. The LMHRA noted that all the medications used met LMHRA’s regulatory requirements, except the Bupivacaine spinal injection, which violated labeling rules.
The violation involved foreign language labeling, a breach of Chapter 2, Section 1, Number 3 of the LMHRA’s labeling regulations, which require all information on medicine labels to be in English. The agency disclosed that in 2022, G2 Pharmacy received a three-year approval from LMHRA to import the Bupivacaine injection after a standard drug dossier review. However, during the investigation, 24 packs of the same drug were discovered at the hospital’s pharmacy—all bearing labels in a foreign language.
Regulatory Actions Taken
LMHRA noted that the 24 packs were confiscated and transferred to the LMHRA’s central office, while the case against G2 Pharmacy was referred to the LMHRA Hearing Board, which initially recommended a fine of US$10,000. However, after an appeal and review of the 2010 LMHRA Act and relevant labeling regulations, the fine was reduced to US$1,500, which has since been paid.
Additional actions recommended by the Board of Directors included post-market surveillance to remove all Bupivacaine Spinal Injections from circulation, refresher training for ADR reporters in health facilities, development of a Standard Operating Procedure (SOP) for the importation of drugs in small quantities, and establishment of a public information system to ensure timely communication of ADR-related issues.
LMHRA emphasized that its core mandate remains to protect the health of the Liberian people by ensuring that only quality-assured medicines and health products circulate in the country.
“We remain committed to our mission and will continue to take regulatory measures that ensure the safety, efficacy, and quality of medicines and health products,” the statement concluded.
