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
ELECTRONIC SUBMISSION OF ADVERSE DRUG REACTION (ADR) REPORTS – E2B REPORTING,

2019 Nov

1pdfDownloadcommunication-to-industry guidelinepharmacovigilance
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

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

2020 Oct

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

2022 Jun

1pdfDownloadcommunication-to-industrypharmacovigilance

VIGILANCE GUIDELINES

VIGILANCE COMMUNICATION TO HEALTH CARE PROFESSIONALS

TitleVersionSubVersionPublish Date
VSIQQ® (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

V11.104-November-2021
COMIRNATY® (COVID-19 mRNA VACCINE) -WARNING REGARDING RARE CASES OF
MYOCARDITIS AND PERICARDITIS

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

V11.120-August-2021
COVID-19 VACCINE JANSSEN

V11.123-July-2021
SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIs) AND SEROTONIN–NOREPINEPHRINE REUPTAKE INHIBITORS (SNRIs) ASSOCIATED WITH THE RISK OF POSTPARTUM HAEMORRHAGE

V11.124-June-2021
VSIQQ  (BROLUCIZUMAB): INCREASED INCIDENCE OF INTRAOCULAR INFLAMMATION (IOI) AND RELATED ADVERSE EVENTS INCLUDING RETINAL VASCULITIS (RV), AND RETINAL VASCULAR OCCLUSION (RO) IN PATIENTS RECEIVING 4 WEEKLY DOSE AFTER THE LOADING TREATMENT

V11.124-June-2021
DOPAMINERGIC MEDICINES USED IN THE TREATMENT OF PARKINSON’S DISEASE: RISK OF DOPAMINE DYSREGULATION SYNDROME

V11.125-May-2021
COVID-19 VACCINE JANSSEN: RISK OF THROMBOSIS IN COMBINATION WITH THROMBOCYTOPENIA

V11.119-May-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
RISK OF DRUG INDUCED LIVER INJURY ASSOCIATED WITH THE USE OF METAMIZOLE-CONTAINING MEDICINES

V11.102-Mar-2021
INCREASED 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

V11.111-Feb-2021
ELTROXIN 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.

V11.124-Dec-2020
DIPHENHYDRAMINE-CONTAINING MEDICINES

v11.120-Nov-2020
Dopaminergic medicines used in the treatment of parkinson’s disease: Risk of Dopamine dysregulation syndrome

V11.128-Oct-2020
Tecentriq® (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs) and Immune-related myositis

V11.117-Nov-2020
Risk of dopamine dysregulation syndrome (DDS) associated with the use of dopaminergic medicines used for the treatment of Parkinson’s disease (PD).

V11.113-Oct-2020
Fluoropyrimidine containing medicines and related substances: Increased drug exposure and toxicity in patients with dihydropyrimidine dehydrogenase (DPD) deficiency

V11.106-Oct-2020
Communication to industry on the sartans-containing medicines

V212-Oct-2020
Tyrosine kinase inhibitors

V11.130-Jun-2020
Ondansetron: Warning about small increased risk of oral clefts following use in the first 12 weeks of pregnancy

V11.102-Jun-2020
Sandoz and Novartis: Warning about small increased risk of oral clefts following use in the first 12 weeks of pregnancy

V11.102-Jun-2020
Fluoroquinolones: risk of mitral and aortic regurgitation associated with the use of oral and injectable fluoroquinolones

V11.102-Jun-2020
DHCPL for ACE-inhibitor/Angiotensin receptor blocker containing medicines

V11.111-Oct-2019
Increased risk of thrombo-embolic events in patients with anti-phopholipid syndrome (APS) treated with Eliquis

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



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

V11.123-Aug-2019
IRisk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers - 1 August 2019

V11.116-Aug-2019
Risk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers -26 June 2019

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

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

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

V11.116-Aug-2019
Dolutegravir - Risk of neural tube defects

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

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

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

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

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

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

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

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

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

V11.125-Apr-2019

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

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

2020 Oct

1pdfDownloadcommunication-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

SAHPRA VIGILANCE – CONTACT DETAILS

To all stakeholders

 

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

For submission of:

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