Medicines and Health Products Regulatory Authority (LMHRA) has issued a formal clarification in response to growing public and media concern following the death of a 16-year-old patient at St. Joseph’s Catholic Hospital in January 2025. The incident, which has been widely reported across local platforms, has reignited national discussions over drug safety and regulatory oversight.
In a public statement, the LMHRA acknowledged that while it does not typically engage in ongoing public commentary regarding sensitive medical cases, the widespread speculation and misinformation necessitate factual clarification.
Background and Investigation
The LMHRA initiated an independent investigation after the Liberia Medical and Dental Council (LMDC) released its report on the patient’s death, which was suspected to be linked to an Adverse Drug Reaction (ADR). The inquiry sought to determine the cause of the ADR, evaluate the regulatory compliance of the drugs administered, and establish preventative measures.
Key findings from the LMHRA investigation include:
The patient received six different medications, including Bupivacaine Spinal Injection (brand name Marcaine® Spinal Heavy, 0.5%).
The type of ADR reported is recognized in clinical practice and is not considered uncommon.
Determining a direct causal relationship between a specific drug and the ADR was deemed inconclusive, given the polypharmacy involved and the lack of comprehensive toxicological testing.
All medications administered were found to be compliant with national regulatory standards—except for the Bupivacaine injection.
The Bupivacaine product violated labeling regulations as it was packaged in a foreign language, contravening Chapter 2, Section 1.3 of LMHRA’s labeling policy, which mandates that “all information contained on the label of medicines and health products must be in English.”
Further review revealed that G2 Pharmacy, which had obtained a three-year market authorization from LMHRA in 2022 for the importation of the Bupivacaine product, had continued to supply the drug despite the labeling noncompliance.
During an on-site inspection, LMHRA investigators identified 24 packs of the improperly labeled Bupivacaine injection still in stock at the hospital.
Regulatory Response
Following its investigation, the LMHRA implemented several regulatory measures:
The 24 remaining packs of the mislabeled Bupivacaine injection were confiscated and transferred to LMHRA’s central office.
The labeling infraction was referred to the LMHRA Hearing Board, which initially imposed a US$10,000 fine on G2 Pharmacy. However, following an appeal and legal review of the LMHRA Act of 2010 and the agency’s Regulations on Mislabeling, the penalty was reduced to US$1,500, which G2 Pharmacy has since paid.
Institutional Recommendations
In response to the broader regulatory concerns raised by the case, LMHRA’s Board of Directors has mandated the following actions:
Post-Market Surveillance to identify and remove all improperly labeled Bupivacaine spinal injections from circulation.
Refresher training for adverse drug reaction (ADR) reporters in health facilities to improve detection and documentation.
Development of a Standard Operating Procedure (SOP) for the importation of “orphan” products—drugs that are imported in small quantities or for rare conditions.
Establishment of a real-time public information system to disseminate ADR alerts and related regulatory updates.
Commitment to Public Health
The LMHRA reaffirmed its commitment to safeguarding the health of the Liberian population by ensuring that only safe, effective, and properly regulated medical products are available in the market.
“We remain unwavering in our core mandate to protect public health by enforcing rigorous quality standards and ensuring regulatory compliance in all aspects of medicine and health product distribution,” the statement concluded.
