Pharmacovigilance Archives - Page 4 of 15

23 May Anviro® (Valaciclovir – Containing Medicine)– Risk of Drug Reaction With Eosinophilia and Systemic Symptoms (Dress)

Posted at 10:29h in

In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Zydus would like to inform you about the risk of drug reaction with eosinophilia and systemic symptoms (DRESS) associated with the use of Anviro® (valaciclovir) tablets....

30 Apr Anagrelide hydrochloride: Risk of thrombosis including cerebral infarction upon abrupt treatment discontinuation

Posted at 14:04h in

Key Oncologies (Pty) Ltd, as directed by the South African Health Products Regulatory Authority (SAHPRA), wish to inform you about the risk of thrombosis, including cerebral infarction, upon abrupt treatment discontinuation of anagrelide hydrochloride....

30 Apr Topical Corticosteroids – Risk of Withdrawal Reactions

Posted at 14:02h in

Organon South Africa (Pty) Ltd, as directed by the South African Health Products Regulatory Authority (SAHPRA), would like to inform you of the risk of withdrawal reactions associated with inappropriate and long-term use of topical corticosteroids....

09 Apr Pseudoephedrine-containing medicines – Risks of Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS) – Reckit

Posted at 14:29h in

Reckitt Benckiser Pharmaceuticals (Pty) Ltd in collaboration with the South African Health Products Regulatory Authority (SAHPRA), wish to draw your attention to the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome associated with the use of pseudoephedrine-containing medicines....

09 Apr Pseudoephedrine-containing Medicines Risk of Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS) – J&J

Posted at 09:03h in

In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Johnson and Johnson (Pty) Ltd would like to inform you about the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) associated with the use of pseudoephedrine-containing medicines....

31 Mar Topiramate – Risk of Neurodevelopmental Disorders

Posted at 15:34h in

In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Ranbaxy Pharmaceuticals (Pty) Ltd South Africa, Zydus Healthcare SA (Pty) Ltd and, Trinity Pharma (Pty) Ltd wish to inform you about the risk of neurodevelopmental disorders in the children born to women exposed to...

27 Feb The Risk of Meningioma Associated With the Use of Medroxyprogesterone Acetate

Posted at 08:39h in

Pfizer and Viatris Healthcare South Africa (Pty) Ltd, in collaboration with the South African Health Products Regulatory Authority (SAHPRA), would like to inform you of the increased risk of meningioma associated with prolonged use....

23 Sep DHCPL – Tegretol S 100 mg Per 5 ml Carbamazepine Suspension

Posted at 11:33h in

Novartis, during its portfolio review (Tegretol S® oral suspension included) observed the possibility of exceeding defined permitted daily exposure (PDE) when the product is taken above 1200 mg/day in adult patients because of the quantity of sorbitol in the formulation. Sorbitol is one of the...

03 Sep DHCPL – Pseudoephedrine-Containing Medicines Risks of PRES and RCVS – iNova Pharmaceuticals

Posted at 07:40h in

The DHCP letter is intended to inform healthcare professionals about the risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) associated with the use of pseudoephedrine-containing medicines. Pseudoephedrine-containing medicines are contraindicated in patients with severe or uncontrolled hypertension, or with severe acute or...

03 Sep DHCPL – Pseudoephedrine-Containing Medicines Risks of PRES and RCVS – Adcock and other Collaborators

Posted at 07:32h in

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