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Safety Information and Updates

No therapeutic product is ever completely risk free. Some risks may be known when a medicine is first entered on the market. However, some information only comes to light after more people use the products.

 

This webpage was developed to provide the public and healthcare professionals with easy access to important drug safety information. The webpage contains the most recent drug safety communications from SAHPRA as well as links for early communications and follow-up.

 

Alerts provide important information and recommendations about therapeutic products. When an alert is issued, it does not necessarily mean a product is considered unsafe.

Vigilance Communication to Industry

Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
Communication to Industry – Summary of Medicine Safety Regulatory Decisions02/06/20231pdfDownloadcommunication-to-industrypharmacovigilance
Summary of Medicine Safety Regulatory Decisions13/04/20231pdfDownloadcommunication-to-industrypharmacovigilance
Electronic Submission Of Adverse Drug Reaction (ADR) Reports – E2b Reporting18/08/20221pdfDownloadcommunication-to-industrypharmacovigilance
Summary of Medicines Safety Regulatory Decisions23/06/20221pdfDownloadcommunication-to-industrypharmacovigilance
21.9Communication to industry on metformin-containing medicines, 14/10/20201Downloadcommunication-to-industry safety-alertspharmacovigilance
21.8Communication to industry on ranitidine-containing medicines, 22/10/20201Downloadcommunication-to-industry safety-alertspharmacovigilance
Communication to industry on Post Marketing Reporting of ADRs guideline31/05/20211pdfDownloadcommunication-to-industrypharmacovigilance

Vigilance Guidelines

Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
SAHPGL-CEM-PV-03Risk Management Plans for Medicines for Human Use15/09/20221pdfDownloadguidelinepharmacovigilance
SAHPGL-CEM-PV-04Post-marketing Reporting Of Adverse Drug Reactions To Human Medicines In South Africa08/06/20229pdfDownloadguidelinepharmacovigilance
SAHPGL-CEM-PV-02Pharmacovigilance systems06/06/20232pdfDownloadguidelinepharmacovigilance
SAHPGL-CEM-PV-01Pharmacovigilance Inspections for Human Medicinal Products10/05/20221pdfDownloadguidelinepharmacovigilance
SAHPGL-CEM-PV-05Guideline for the handling of Dear Healthcare Professional Letters relating to medicine safety25/08/20226pdfDownloadguidelinepharmacovigilance
SAHPGL-CEM-PV-06Guideline For Adverse Drug Reactions (ADRs) Reporting for Healthcare Professionals18/08/20223pdfDownloadguidelinepharmacovigilance

Vigilance Forms

Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
ALL VACCINES including COVID-19 : Case Reporting Form (CRF) for Adverse Events Following Immunisation (AEFI)29/01/20211pdfDownloadformpharmacovigilance
COVID-19: Case Reporting Form (CRF) for suspected Adverse Events of Special Interest (AESI)28/01/20211pdfDownloadformpharmacovigilance
ALL VACCINES including COVID-19: Case Investigation Form (CIF) Adverse Events Following Immunisation (AEFI) AND Adverse Events of Special Interest (AESI)28/01/20211pdfDownloadformpharmacovigilance
GLF-CEM-PV-06AAdverse Drug Reactions and Quality Problem Reporting Form22/11/20233pdfDownloadformpharmacovigilance
GLF-CEM-PV-S01Valproate Annual Risk Acknowledgement Form18/08/20221pdfDownloadformpharmacovigilance

Vigilance Communication to Health Care Professionals

Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
DHCPLThe risk of acute tubulointerstitial nephritis (TIN) associated with proton pump inhibitors (PPIs)30/10/20231pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLGolimumab SIMPONI® 50 mg: Important Changes to the Instructions For Use (IFU) for the SmartJect® Autoinjector/Pre-filled Pen04/10/20231pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLSection 36 approval – KLACID XL04/09/20231pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLSection 36 Approval – MeasBio Vaccine17/07/20231pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLBupropion Containing Medicines – Risk Of Brugada Syndrome (Adcock, Tev, Acino, and SunPharma)22/05/20231pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLBupropion containing medicines – Risk of of Brugada Syndrome (GSK)08/06/20231pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLSynthroid – Range of tablets: Typing error in Professional Information (PI) and Patient Information Leaflet (PIL)21/05/20231pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLGabapentinoids – Risk of Serious Breathing Difficulty18/04/20231pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLDHCPL_Section 36 approval – Measbio vaccine12/04/20231wwwDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLTopical corticosteroids – DHCPL – Risk of withdrawal reactions19/10/20221pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLAnagrelide hydrochloride: Risk of thrombosis including cerebral infarction upon abrupt treatment discontinuation17/08/20221pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLCefepime hydrochloride – Risk of serious adverse reactions17/04/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLValproate containing medicines – High risk of congenital abnormalities and development disorders03/04/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLClozapine – Induced gastrointestinal hypomotility17/04/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLHydrochlorothiazide – Risk of non-menoloma skin cancer10/04/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLLamotrigine – Risk of Hemophagocytic Lymphohistiocytosis17/04/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLHyoscine Butylbromide – Risk of adverse effects in patients with underlying cardiac disease03/04/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLAmphotericin B – Risk of Medication Error10/04/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLEPOETIN ALFA – New warnings on severe cutaneous adverse reaction11/04/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLGadolinium-Based Contrast Agents – Deposition in the brain11/04/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLDolutegravir – Risk of neural tube defects09/04/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLRisk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers13/06/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLRisk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers13/06/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLRisk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers17/07/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLRisk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers16/08/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLRisk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers – 1 August 201916/08/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLIncreased risk of thrombo-embolic events in patients with anti-phopholipid syndrome (APS) treated with Pradaxa16/08/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLIncreased risk of thrombo-embolic events in patients with anti-phopholipid syndrome (APS) treated with Xarelto15/08/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLIncreased risk of thrombo-embolic events in patients with anti-phopholipid syndrome (APS) treated with Eliquis13/09/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLDHCPL for ACE-inhibitor/Angiotensin receptor blocker containing medicines11/10/20191pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLFluoroquinolones: risk of mitral and aortic regurgitation associated with the use of oral and injectable fluoroquinolones10/06/20201pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLSandoz and Novartis: Warning about small increased risk of oral clefts following use in the first 12 weeks of pregnancy12/06/20201pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLOndansetron: Warning about small increased risk of oral clefts following use in the first 12 weeks of pregnancy12/06/20201pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLTyrosine kinase inhibitors18/06/20201pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLFluoropyrimidine containing medicines and related substances: Increased drug exposure and toxicity in patients with dihydropyrimidine dehydrogenase (DPD) deficiency22/10/20201pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLRisk of dopamine dysregulation syndrome (DDS) associated with the use of dopaminergic medicines used for the treatment of Parkinson’s disease (PD).25/11/20211pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLTecentriq® (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs) and Immune-related myositis19/11/20201pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLDopaminergic medicines used in the treatment of parkinson’s disease: Risk of Dopamine dysregulation syndrome22/10/20201pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLDiphenhydramine-containing Medicines20/11/20201pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLEltroxin New Formulation (25 Mcg, 50 Mcg, 75 Mcg, 100 And 200 Mcg Tablets: Increased Adverse Events Reports And Requirement For Patient Therapeutic Monitoring By Healthcare Professionals.09/12/20201pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLIncreased Risk Of Subclinical Acute Interstitial Nephritis Associated With The Use Of Proton Pump Inhibitors (Ppis) Leading To Acute Kidney Injury And/or Chronic Renal Failure11/02/20211pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLRisk Of Drug Induced Liver Injury Associated With The Use Of Metamizole-containing Medicines18/03/20211pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLSAHPRA launches the Med Safety App for self-reporting of suspected Adverse Drug Reactions by the Public and Healthcare Professionals07/04/20211wwwDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLCOVID-19 Vaccine Janssen: Risk of Thrombosis in combination with Thrombocytopenia18/11/20211pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLDopaminergic Medicines used in the treatment of Parkinson’s Disease: Risk of Dopamine Dysregulation Syndrome13/05/20211pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLSelective Serotonin Reuptake Inhibitors (SSRIS) and Serotonin–Norepinephrine Reuptake Inhibitors (SNRIS) associated with the risk of Postpartum Haemorrhage19/06/20211pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLCOVID-19 Vaccine Janssen23/07/20211pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLSAHPRA Statement on Adverse Events Following Immunisation (AEFIs) with COVID 19 Vaccines12/08/20211wwwDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLCOMIRNATY® (COVID-19 mRNA Vaccine) -Warning regarding rare cases of Myocarditis and Pericarditis13/08/20211pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLVSIQQ® (Brolucizumab) – A Requirement to Discontinue Treatment with Vsiqq® in Patients who Develop Retinal Vasculitis and/or Retinal Vascular Occlusion, Typically in the Presence of Intraocular Inflammation24/11/20211pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLTopical Corticosteroid – Risk of Withdrawal Reactions – Aspen16/08/20222pdfDownloadcommunication-to-health-care-professionalspharmacovigilance

Vigilance Communication to the Public

TitleVersionSubVersionPublish Date
Communication to Public - Summary of Medicine Safety Regulatory Decisions

V11.113-April-2023
Communication to Public - Summary of Medicines Safety Regulatory Decisions

V11.113-June-2022
A SIGNAL OF MYOCARDITIS / PERICARDITIS ASSOCIATED WITH PFIZER-BIONTECH’S COVID-19 VACCINE, COMIRNATY (BNT162B2)

V11.126-August-2021
SAHPRA Statement on Adverse Events Following Immunisation (AEFIs) with COVID 19 Vaccines

V11.120-August-2021
SAHPRA launches the Med Safety App for self-reporting of suspected Adverse Drug Reactions by the Public and Healthcare Professionals

V11.122-April-2021

Vigilance Newsletters

VigiGuardian Newsletters

Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
VigiGuardian Newsletter July 202214/07/20221pdfDownloadnewsletterpharmacovigilance
VigiGuardian Newsletter April 202228/04/20221pdfDownloadnewsletterpharmacovigilance

Vigilance Manual

Vigilance Manual

Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
Vaccine Safety Surveillance (VSS) In South Africa, 09/10/20231wwwDownloadguide manualpharmacovigilance

Medicine Safety Alerts

Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
21.1MSA ketoconazole and domperidone12/07/20061pdfDownloadsafety-alertspharmacovigilance
21.3MSA Rotarix12/03/20081pdfDownloadsafety-alertspharmacovigilance
21.2MSA promethazine13/09/20071pdfDownloadsafety-alertspharmacovigilance
21.4MSA atypical antipsychotics24/06/20092pdfDownloadsafety-alertspharmacovigilance
21.6MSA cough and cold medicines20/06/20121pdfDownloadsafety-alertspharmacovigilance
21.5MSA gamma benzine hexachloride22/06/20121pdfDownloadsafety-alertspharmacovigilance
21.9Communication to industry on metformin-containing medicines, 14/10/20201Downloadcommunication-to-industry safety-alertspharmacovigilance
21.8Communication to industry on ranitidine-containing medicines, 22/10/20201Downloadcommunication-to-industry safety-alertspharmacovigilance
DIPHENHYDRAMINE-CONTAINING MEDICINES30/11/20201pdfDownloadsafety-alertspharmacovigilance
A SIGNAL OF MYOCARDITIS / PERICARDITIS ASSOCIATED WITH PFIZER-BIONTECH’S COVID-19 VACCINE, COMIRNATY (BNT162B2)19/08/20211pdfDownloadsafety-alertspharmacovigilance

Medicine/Product Recalls

View Recalls

SAHPRA Vigilance – Contact Details

To all stakeholders

 

Kindly note different email addresses that should be used for different vigilance submissions as stipulated below.

 

ADR reports in an e2b in an xml format e2b@sahpra.org.za
All other Adverse Drug Reaction (ADR) reports adr@sahpra.org.za
Pharmacovigilance related queries pvqueries@sahpra.org.za
Documentation relating to identified safety concerns, responses to PV recommendations, PSURs/PBRER, Risk Management Plans (RMPs) pvsubmissions@sahpra.org.za

 

 

 

 

 

 

 

 

 

Please refrain from sending one document to all email addresses as this creates duplication of reporting and misuse of resources.