Safety Information and Updates

A health product is registered and made available in South Africa, based on the safety information obtained from clinical trials. Clinical trials provide information about many of the adverse events associated with a health product, but do not detect all possible adverse events. It is therefore important for the safety profile of a product to continuously be monitored throughout its life-cycle. SAHPRA, like other Regulatory Authorities around the globe, monitors the safety profiles of health products to ensure that their risk-benefit profiles remain favourable.

 

Through the product safety-monitoring program, SAHPRA issues safety updates to the public, consumers, healthcare professionals and industry about emerging safety information. Safety updates provide important safety information, recommendations or advice about health products. Reporting of adverse drug events by consumers, patients and health professionals provide important information for SAHPRA’s product safety monitoring program. To report and Adverse Drug Reaction, access our ADR reporting systems here.

DEAR HEALTH CARE PROFESSIONAL LETTERS

Doc#TitleVersionSubVersionPublish Date
1Dolutegravir - Risk of neural tube defects

V11.124-Apr-2019
1Gadolinium-Based Contrast Agents - Deposition in the brain

V11.125-Apr-2019
1EPOETIN ALFA - New warnings on severe cutaneous adverse reaction

V11.125-Apr-2019
1Amphotericin B - Risk of Medication Error

V125-Apr-2019
1Hyoscine Butylbromide - Risk of adverse effects in patients with underlying cardiac disease

V11.125-Apr-2019
1Lamotrigine - Risk of Hemophagocytic Lymphohistiocytosis

V11.125-Apr-2019
1Hydrochlorothiazide - Risk of non-menoloma skin cancer

V11.125-Apr-2019
1Clozapine - Induced gastrointestinal hypomotility

V11.125-Apr-2019
1Valproate containing medicines - High risk of congenital abnormalities and development disorders

V11.125-Apr-2019
1Cefepime hydrochloride - Risk of serious adverse reactions

V11.125-Apr-2019
1Risk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers -26 June 2019

V11.116-Aug-2019
1Risk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers - 19 June 2019

V11.116-Aug-2019
1Risk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers 31 July 2019

V11.116-Aug-2019
1IRisk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers - 1 August 2019

V11.116-Aug-2019
1Risk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers - 7 June 2019

V11.116-Aug-2019
1Increased risk of thrombo-embolic events in patients with anti-phopholipid syndrome (APS) treated with Pradaxa

V11.123-Aug-2019
1Increased risk of thrombo-embolic events in patients with anti-phopholipid syndrome (APS) treated with Eliquis

V11.123-Sep-2019
1Increased risk of thrombo-embolic events in patients with anti-phopholipid syndrome (APS) treated with Xarelto



V11.123-Sep-2019
1DHCPL for ACE-inhibitor/Angiotensin receptor blocker containing medicines

V11.111-Oct-2019

MEDICINE SAFETY ALERTS

Doc#TitleVersionSubVersionPublish Date
21.5MSA gamma benzine hexachloride

V104-Jun-2012
21.6MSA cough and cold medicines

V104-Jun-2012
21.4MSA atypical antipsychotics

V215-Jun-2009
21.3MSA Rotarix

V103-Mar-2008
21.2MSA promethazine

V103-Sep-2007
21.1MSA ketoconazole and domperidone

V103-Jul-2006