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.

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
1 Ondansetron: Warning about small increased risk of oral clefts following use in the first 12 weeks of pregnancy

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

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

V11.102-Jun-2020
1Tyrosine kinase inhibitors

V11.130-Jun-2020
1Fluoropyrimidine containing medicines and related substances: Increased drug exposure and toxicity in patients with dihydropyrimidine dehydrogenase (DPD) deficiency

V11.106-Oct-2020
1Risk 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
1 Dopaminergic medicines used in the treatment of parkinson’s disease: Risk of Dopamine dysregulation syndrome

V11.128-Oct-2020

MEDICINE SAFETY ALERTS

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.

 

Additionally, a telephonic contact on (012) 842 7609/10 during working hours.