There have been several cases around the world in which Tranexamic acid has been administered intrathecally in error instead of the local anaesthetic agent, bupivacaine.(1) Postpartum haemorrhage is the third most common cause of death in obstetric practice in developing countries. Tranexamic acid is life-saving in...
The South African Health Products Regulatory Authority (SAHPRA) would like to inform you of a signal of myocarditis / pericarditis associated with Pfizer-BioNTech’s Covid-19 vaccine, Comirnaty® (BNT162b2). The Pfizer/BioNTech Comirnaty® Vaccine was approved by SAHPRA in March 2021. The authorisation was done in terms of...
In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Roche Products (Pty) Ltd would like to inform you of the risk of drug-induced liver injury (DILI) associ- ated with use of Esbriet® (pirfenidone): The Professional Information (PI) and Patient Information Leaflet (PIL) will be updated...
SAHPRA alerts all healthcare professionals about the risk of serious heart problems, seizures, coma and death associated with the use of high doses of diphenhydramine- containing medicines. The South African Health Products Regulatory Authority (SAHPRA) wishes to alert healthcare professionals about the risk of serious heart...
The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulatory agencies, are reviewing the final pharmaceutical products for immediate and extended release dosage forms containing metformin hydrochloride as an active substance. This review was triggered because of the detection of an impurity,...
The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulatory agencies, are reviewing all ranitidine-containing medicines with the following Active Pharmaceutical Ingredient; ranitidine. SAHPRA previously issued a media release regarding the recall and quarantine of ranitidine containing medicines (29 October 2019 and...
The Medicines Control Council (MCC) of South Africa wishes to alert healthcare professionals that the use of oral cough and cold medicines containing certain ingredients is now contraindicated in children under the age of two years. This decision is in line with international recommendations regarding the...
The Medicines Control Council wishes to inform prescribers of increased risks of cerebrovascular adverse events (including strokes and transient ischaemic attacks) and mortality associated with the use of atypical antipsychotics in elderly patients with dementia. The atypical antipsychotics to which this medicine safety alert refers...
The Medicines Control Council (MCC) wishes to alert healthcare professionals and consumers to the risk of adverse events associated with the prolonged or repeated use of gamma benzene hexachloride (lindane)-containing shampoos (Gambex® and Quellada® Shampoos). After a review of the risk-benefit profile of these products, the...
The Medicines Control Centre (MCC) wishes to draw the attention of all health care professionals to the correct route of administration of Rotarix Vaccine. Rotarix Vaccine is indicated for the prevention of gastroenteritis caused by Rotavirus, G1 and non- G1 serotypes (such as G2, G3, G4...
