Safety Alerts Recalls

Safety Alerts Safety Information Find the latest safety communications, safety alerts and educational materials issued by BoMRA Safety Information Factsheets 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 recent recall notice issued by The National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria, for a specific batch of Benylin® Paediatric Syrup. This is a product manufactured by Johnson & Johnson (Pty) Ltd, South Africa. Stakeholders and the public are informed that this recall alert is specific and targeted to certain batches of specified manufacturing and expiry dates. Download 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 cerebral vasoconstriction syndrome (RCVS) associated with the use of these medicines containing pseudoephedrine. Download 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. Download 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 active substances in products that treat the symptoms of cold and flu. Pholcodine containing products registered in Botswana are; 1. Pholtex Forte 15mg/5ml (Pholcodine) 2. Pholtex junior linctus 5mg/5ml (Pholcodine) 3. Tixylix (Promethazine & pholcodine). Download 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 and NMBA-related POA (OR adjusted 4.2 CI 95% [2.5; 6.9]). Other environmental factors, including occupational exposure to quaternary ammonium, should be considered in the risk of NMBA-related anaphylaxis, but they currently remain poorly defined. The European Commission issued a legally binding decision applicable in all EU Member States to withdraw pholcodine containing products in March 2023. Subsequent to this a number of National Regulatory Authorities have removed Pholcodine from their markets and these include United Kingdom, Australia, Malaysia and South Africa. Download 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: Download Tegretol Oral Suspension, limitation of use in neonates During a 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 exc

Source: Original reporting via Botswana Medicines Regulatory Authority