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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 on Post Marketing Reporting of ADRs guideline

2021 May

1pdfDownloadcommunication-to-industrypharmacovigilance
21.8Communication to industry on ranitidine-containing medicines,

2020 Oct

1Downloadcommunication-to-industry safety-alertspharmacovigilance
21.9Communication to industry on metformin-containing medicines,

2020 Oct

1Downloadcommunication-to-industry safety-alertspharmacovigilance
Summary of Medicines Safety Regulatory Decisions

2022 Jun

1pdfDownloadcommunication-to-industrypharmacovigilance
Electronic Submission Of Adverse Drug Reaction (ADR) Reports – E2b Reporting

2022 Aug

1pdfDownloadcommunication-to-industrypharmacovigilance

Vigilance Guidelines

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
SAHPGL-CEM-PV-06Guideline For Adverse Drug Reactions (ADRs) Reporting for Healthcare Professionals

2022 Aug

3pdfDownloadguidelinepharmacovigilance
SAHPGL-CEM-PV-05Guideline for the handling of Dear Healthcare Professional Letters relating to medicine safety

2022 Aug

6pdfDownloadguidelinepharmacovigilance
SAHPGL-CEM-PV-01Pharmacovigilance Inspections for Human Medicinal Products

2022 May

1pdfDownloadguidelinepharmacovigilance
SAHPGL-CEM-PV-02Pharmacovigilance systems

2022 May

1pdfDownloadguidelinepharmacovigilance
SAHPGL-CEM-PV-04POST-MARKETING REPORTING OF ADVERSE DRUG REACTIONS TO HUMAN MEDICINES IN SOUTH AFRICA

2022 Jun

9pdfDownloadguidelinepharmacovigilance
SAHPGL-CEM-PV-03Risk Management Plans for Medicines for Human Use

2022 Sep

1pdfDownloadguidelinepharmacovigilance

Vigilance Communication to Health Care Professionals

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
DHCPLTopical corticosteroids – DHCPL – Risk of withdrawal reactions

2022 Oct

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLAnagrelide hydrochloride: Risk of thrombosis including cerebral infarction upon abrupt treatment discontinuation

2022 Aug

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLCefepime hydrochloride – Risk of serious adverse reactions

2019 Apr

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLValproate containing medicines – High risk of congenital abnormalities and development disorders

2019 Apr

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLClozapine – Induced gastrointestinal hypomotility

2019 Apr

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLHydrochlorothiazide – Risk of non-menoloma skin cancer

2019 Apr

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLLamotrigine – Risk of Hemophagocytic Lymphohistiocytosis

2019 Apr

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLHyoscine Butylbromide – Risk of adverse effects in patients with underlying cardiac disease

2019 Apr

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLAmphotericin B – Risk of Medication Error

2019 Apr

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLEPOETIN ALFA – New warnings on severe cutaneous adverse reaction

2019 Apr

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLGadolinium-Based Contrast Agents – Deposition in the brain

2019 Apr

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLDolutegravir – Risk of neural tube defects

2019 Apr

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLRisk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers

2019 Jun

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLRisk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers

2019 Jun

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLRisk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers

2019 Jul

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLRisk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers

2019 Aug

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLRisk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers – 1 August 2019

2019 Aug

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLIncreased risk of thrombo-embolic events in patients with anti-phopholipid syndrome (APS) treated with Pradaxa

2019 Aug

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLIncreased risk of thrombo-embolic events in patients with anti-phopholipid syndrome (APS) treated with Xarelto

2019 Aug

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLIncreased risk of thrombo-embolic events in patients with anti-phopholipid syndrome (APS) treated with Eliquis

2019 Sep

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLDHCPL for ACE-inhibitor/Angiotensin receptor blocker containing medicines

2019 Oct

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLFluoroquinolones: risk of mitral and aortic regurgitation associated with the use of oral and injectable fluoroquinolones

2020 Jun

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLSandoz and Novartis: Warning about small increased risk of oral clefts following use in the first 12 weeks of pregnancy

2020 Jun

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLOndansetron: Warning about small increased risk of oral clefts following use in the first 12 weeks of pregnancy

2020 Jun

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLTyrosine kinase inhibitors

2020 Jun

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLFluoropyrimidine containing medicines and related substances: Increased drug exposure and toxicity in patients with dihydropyrimidine dehydrogenase (DPD) deficiency

2020 Oct

1pdfDownloadcommunication-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).

2021 Nov

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLTecentriq® (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs) and Immune-related myositis

2020 Nov

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLDopaminergic medicines used in the treatment of parkinson’s disease: Risk of Dopamine dysregulation syndrome

2020 Oct

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLDiphenhydramine-containing Medicines

2020 Nov

1pdfDownloadcommunication-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.

2020 Dec

1pdfDownloadcommunication-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 Failure

2021 Feb

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLRisk Of Drug Induced Liver Injury Associated With The Use Of Metamizole-containing Medicines

2021 Mar

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLSAHPRA launches the Med Safety App for self-reporting of suspected Adverse Drug Reactions by the Public and Healthcare Professionals

2021 Apr

1wwwDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLCOVID-19 Vaccine Janssen: Risk of Thrombosis in combination with Thrombocytopenia

2021 Nov

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLDopaminergic Medicines used in the treatment of Parkinson’s Disease: Risk of Dopamine Dysregulation Syndrome

2021 May

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLSelective Serotonin Reuptake Inhibitors (SSRIS) and Serotonin–Norepinephrine Reuptake Inhibitors (SNRIS) associated with the risk of Postpartum Haemorrhage

2021 Jun

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLCOVID-19 Vaccine Janssen

2021 Jul

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLSAHPRA Statement on Adverse Events Following Immunisation (AEFIs) with COVID 19 Vaccines

2021 Aug

1wwwDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLCOMIRNATY® (COVID-19 mRNA Vaccine) -Warning regarding rare cases of Myocarditis and Pericarditis

2021 Aug

1pdfDownloadcommunication-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 Inflammation

2021 Nov

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLTopical Corticosteroid – Risk of Withdrawal Reactions – Aspen

2022 Aug

2pdfDownloadcommunication-to-health-care-professionalspharmacovigilance

Vigilance Communication to the Public

TitleVersionSubVersionPublish Date
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 April 2022

2022 Apr

1pdfDownloadnewsletterpharmacovigilance
VigiGuardian Newsletter July 2022

2022 Jul

1pdfDownloadnewsletterpharmacovigilance

Medicine Safety Alerts

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
A SIGNAL OF MYOCARDITIS / PERICARDITIS ASSOCIATED WITH PFIZER-BIONTECH’S COVID-19 VACCINE, COMIRNATY (BNT162B2)

2021 Aug

1pdfDownloadsafety-alertspharmacovigilance
DIPHENHYDRAMINE-CONTAINING MEDICINES

2020 Nov

1pdfDownloadsafety-alertspharmacovigilance
21.8Communication to industry on ranitidine-containing medicines,

2020 Oct

1Downloadcommunication-to-industry safety-alertspharmacovigilance
21.9Communication to industry on metformin-containing medicines,

2020 Oct

1Downloadcommunication-to-industry safety-alertspharmacovigilance
21.5MSA gamma benzine hexachloride

2012 Jun

1pdfDownloadsafety-alertspharmacovigilance
21.6MSA cough and cold medicines

2012 Jun

1pdfDownloadsafety-alertspharmacovigilance
21.4MSA atypical antipsychotics

2009 Jun

2pdfDownloadsafety-alertspharmacovigilance
21.2MSA promethazine

2007 Sep

1pdfDownloadsafety-alertspharmacovigilance
21.3MSA Rotarix

2008 Mar

1pdfDownloadsafety-alertspharmacovigilance
21.1MSA ketoconazole and domperidone

2006 Jul

1pdfDownloadsafety-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.