Risk of Acute Pancreatitis, Including Necrotizing and Fatal Cases, Associated with GLP‑1 Receptor Agonists and Dual GLP‑1/GIP Receptor Agonists.
Botswana Medicines Regulatory Authority (BoMRA) is responsible for ensuring the safety, efficacy, and quality of medicines and related substances, including human and veterinary medicines, medical devices, and cosmetics in Botswana. In line with its ongoing surveillance of medicine safety, BoMRA wishes to draw attention to an important emerging safety concern regarding a potential risk of […]
Tegretol Oral Suspension, limitation of use in neonates
During an ongoing procedure in another country for label update for Tegretol® 100 mg/5ml Oral Suspension, the process triggered an assessment of the amount of propylene glycol in the product. Propylene Glycol, an excipient used in this product formulation, was found to be above the threshold of (1 mg/kg/day) for neonates (refer to respective EMA […]
Hydrochlorothiazide – Risk Of Non Melanoma Skin Cancer ( Basal Cell Carcinoma, Squamous Cell Carcinoma)
In agreement with Botswana Medicines Regulatory Authority,(BOMRA) Sanofi would like to inform you of the following about HCTZ-containing products:
Cautionary Statement on Benylin Paediatric 100mls Cough Syrup, Batch No 329304 and 329303
The Botswana Medicines Regulatory Authority (BoMRA) wishes to alert its stakeholders and the public regarding a recentrecall notice issued by The National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria, for aspecific batch of Benylin® Paediatric Syrup. This is a product manufactured by Johnson & Johnson (Pty) Ltd, South Africa.Stakeholders and the […]
Risk of serious side effects with medicines containing pseudoephedrine
The Botswana Medicines Regulatory Authority (BoMRA) would like to inform you about a safety concern regarding medicines containing pseudoephedrine. Pseudoephedrine is used to relieve nasal, or sinus congestion caused by the common cold, sinusitis, and hay fever and other respiratory allergies. Recent evidence suggests a potential risk of posterior reversible encephalopathy syndrome (PRES) and reversible […]
Safety Concern- Acute Interstitial Nephritis asscoiated with Proton Pump Inhibitorss
The Botswana Medicines Regulatory Authority (BOMRA) wishes to bring to your attention a safety concern associated with the use of Proton Pump Inhibitors (PPIs), specifically their potential to trigger acute interstitial nephritis, a serious adverse event linked to acute kidney injury.
Pholcodine consumption increases the risk of perioperative anaphylaxis to neuromuscular blocking agents
Pholcodine is an opioid medicine that works by suppressing the cough reflex in the brain thus reducing the nerve signals that are sent to the muscles involved in coughing. It is used in adults and children to treat nonproductive (dry) coughs and is most commonly used in cough syrups and often in combination with other […]
Pholcodine DHCP Letter
BOMRA has reviewed literature that associate pholcodine and perioperative anaphylaxis Data from a multicenter case-control study (ALPHO) comparing pholcodine exposure within a year before anesthesia between patients with NMBA-related POA (cases) and control patients with uneventful aesthesia was reviewed. The ALPHO has confirmed a significant association between pholcodine consumption in the year preceding NMBA exposure […]
Suspected Adverse Drug Reactions of Angiotensin 11 converting enzyme inhibitors reported to BoMRA
Botswana Medicines Regulatory Authority (BoMRA) continues to monitor safety of medicinal products registered in Botswana. One of the key activities is to advocate for adverse drug reactions (ADRs) reporting, assessment, and analysis. BoMRA has analyzed safety reports associated with angiotensin converting enzyme inhibitors (ACEIs) received between 1st April 2019 and 28th February 2023.
Bedaquiline-containing regimenscardiac adverse events
Bedaquiline is an antimycobacterial drug used for the treatment of pulmonary multidrug resistant tuberculosis.Bedaquiline inhibits adenosine 5′-triphosphate (ATP) synthesis, a process that is crucial to the growth of mycobacteriumand to its survival in its non-growing dormant state. Bedaquiline is recommended for the treatment of pulmonaryMultidrug Resistant Tuberculosis (MDR-TB) and Rifampicin Resistant-Tuberculosis medicines (RR-TB) by world […]