The National Drug Authority (NDA) has ordered an immediate recall of all batches of the anesthesia drug Bupitroy Heavy from the Ugandan market, citing severe and potentially fatal side effects.
In an Oct. 16 letter to the pharmacist in charge at Abacus Pharma (A) Ltd., NDA Secretary Dr. David Nahamya said the regulator had received multiple complaints from health facilities over an extended period.
“The National Drug Authority has received multiple complaints from health facilities concerning the product over an extended period, including severe, life-threatening adverse drug reactions, some with fatal outcomes,” Nahamya wrote.
The NDA said the drug — whose generic name is bupivacaine — also failed to deliver its intended pharmacological effect, resulting in inadequate anesthesia and treatment failures.
“You are hereby instructed to conduct an immediate recall of all batches of this product on the market,” the letter read.
The NDA classified the move as a Class A recall, its most serious category. Such a classification signifies a “reasonable probability” that the drug could cause serious health consequences or death, requiring urgent removal from circulation.
An NDA source, speaking on condition of anonymity, said the decision was made to protect patients from further harm. “This is a critical measure to safeguard public health. A Class A recall signals that the drug’s risks significantly outweigh its benefits,” the source said.
Abacus Pharma has been instructed to submit a detailed recall status report within three days, including the quantity and distribution of the drug, a list of clients notified, and feedback received.
A 2023 report by Dr. Fourutan Shafiei and colleagues at the Kendall Regional Medical Center in the United States cautioned clinicians to “exercise caution in patients with hypersensitivity to sulfites, liver or kidney impairment, cardiac dysfunction, or in elderly and acutely ill patients.”
It remains unclear whether clinicians in Uganda followed all recommended guidelines when administering the drug or were fully aware of its risks. NDA officials reiterated that a Class A recall is issued only when the risks of using a product clearly outweigh its benefits.
The recall adds to a growing list of drug safety interventions. In August, the NDA ordered the withdrawal of calcium gluconate, a critical medication for heart conditions, over safety concerns. Between 2021 and 2022, NDA records show at least 19 drugs and medical devices were recalled in Uganda due to safety or potency issues.
