The National Drug Authority (NDA) has ordered an immediate recall of all batches of the anaesthesia drug Bupitroy Heavy from the Ugandan market, citing severe and potentially fatal side effects. In an October 16 letter addressed to the pharmacist-in-charge at Abacus Pharma (A) Ltd, the NDA Secretary, Dr David Nahamya, said the regulator had received multiple complaints from health facilities over an extended period.
‘The National Drug Authority (NDA) has received multiple complaints from health facilities concerning the product noted below over an extended period, including: Severe, life-threatening adverse drug reactions, some with fatal outcomes,’ Dr Nahamya stated. NDA also noted that the drug, whose generic name is Bupivacaine, failed to deliver its intended pharmacological effect, resulting in inadequate anaesthesia and treatment failures.
‘You are hereby instructed to conduct an immediate recall of all batches of this product on the market,’ the letter reads. The NDA classified the action as a Class A recall, the most serious category. The regulator says a Class A recall signifies a ‘reasonable probability’ that the drug could cause serious health consequences or death, requiring urgent removal from circulation to protect patients.
An NDA source underscored the urgency of the recall: ‘This is a critical measure to safeguard public health. A Class A recall signals that the drug’s risks significantly outweigh its benefits, posing a substantial threat of serious harm or fatality,’ the source said. Abacus Pharma has been instructed to submit a detailed recall status report within three days. The report must include the quantity and distribution of the drug, a list of clients notified, and feedback received.
Global regulatory bodies such as the US Food and Drug Administration (FDA) and the UK’s Medicines and Healthcare Products Regulatory Agency list Bupivacaine as a widely used aesthetic. According to the US National Centre for Biotechnology Information (NCBI), the drug was first discovered in 1957. Locally, NDA records confirm that Bupivacaine is registered for human use in Uganda, meaning it passed regulatory assessment and was approved for sale. The NDA letter did not cite specific product defects. However, sources suggested that ‘by the time of testing the product was fine. Maybe issues came from how the drug was stored.’ The NDA drug register lists Troikaa Pharmaceuticals Limited as the licence holder, with Abacus Pharma (Africa) Ltd serving as the local technical representative.
Bupivacaine is used as a local aesthetic during surgical procedures. According to NCBI, common side effects include nausea, vomiting, chills, headache, back pain, dizziness, sexual dysfunction, restlessness, anxiety, vertigo, and tinnitus. More serious adverse effects include blurry vision, tremors, convulsions, myoclonic jerks, coma, and cardiovascular collapse, which can be fatal. A 2023 report by Dr Fourutan Shafiei and colleagues at the Kendall Regional Medical Centre in the US advises clinicians to ‘exercise caution in patients with hypersensitivity to sulfites, liver impairment (the liver clears amides), kidney impairment, impaired cardiac function, heart block, elderly, debilitated, or 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 sources reiterated that a Class A recall is only issued when the drug’s risks outweigh its benefits. ‘It is supposed to address a situation in which there is a reasonable probability that the use of, or exposure to, a volatile product will cause serious adverse health consequences or death,’ another NDA source added.
Rising trend
In August, NDA ordered the withdrawal of calcium gluconate, a critical medication for heart conditions, over safety concerns. Between 2021 and 2022, NDA records show that at least 19 drugs and medical devices were recalled in Uganda due to safety or potency issues, reflecting the regulator’s active post-market surveillance efforts.