WHO Pharmaceuticals Newsletter 2003, No. 05
(2003; 15 pages) View the PDF document
Table of Contents
Close this folderREGULATORY MATTERS
View the documentASTEMIZOLE - Withdrawn due to ventricular arrhythmias
View the documentBICALUTAMIDE - Withdrawn due to accelerated deaths
View the documentDACLIZUMAB - Warning about hypersensitivity reactions, increased mortality in cardiac transplant study
View the documentDANAZOL - Use restricted to second-line therapy in endometriosis
View the documentLEVACETYL-METHADOL - Product to be withdrawn due to adverse cardiac events; safer alternatives to be adopted
View the documentMOROCTOCOG ALFA - Reports of lack of effect in prophylaxis patients
View the documentNEFAZODONE - Sale discontinued due to adverse hepatic events
View the documentNIMESULIDE - Product under ‘special pharmacovigilance’
View the documentOSELTAMIVIR - Adverse reactions section to include acute renal failure, thrombocytopenia, leucopenia
View the documentPHENYLPROPAN-OLAMINE - New warnings on cardiovascular risks to be added
View the documentSOMATROPIN - Refused approval for use in AIDS-related wasting syndrome
View the documentTERFENADINE - Withdrawn due to ventricular arrhythmias
View the documentVALSARTAN - Reports of interstitial pneumonia
Open this folder and view contentsSAFETY OF MEDICINES
Open this folder and view contentsDRUGS OF INTEREST
Open this folder and view contentsFEATURE
Open this folder and view contentsMISCELLANY
 

MOROCTOCOG ALFA - Reports of lack of effect in prophylaxis patients

Canada. Wyeth Canada is informing physicians of changes to the Precautions and Adverse Reactions sections of the product monograph for moroctocog alfa (Refacto, Recombinant Anti-haemophilic Factor). Moroctocog alfa (Refacto, Antihaemophilic Factor Recombinant) has been licensed in Canada since 2002 and is indicated for the control and prevention of haemorrhagic episodes and for routine and surgical prophylaxis in patients with haemophilia A. Reports of lack of effect, mainly in prophylaxis patients, have been received during the clinical trials and in the post-marketing setting with this product (Refacto, Antihaemophilic Factor) in Canada. The lack of effect and/or low factor VIII recovery has been reported in patients with inhibitors and also in patients who had no evidence of inhibitors. The lack of effect has been described as bleeding into target joints, bleeding into new joints, other bleeding or a subjective feeling by the patient of new onset bleeding. The product insert now reflects these observations and advises that, in view of these reports of less than expected therapeutic effect, it is important to individually titrate and monitor each patient’s dose of moroctocog alfa (ReFacto), particularly when initiating treatment, to ensure an adequate therapeutic response.

Reference:
‘Dear Healthcare Professional’ letter from Wyeth Canada, 30 Sept 2003.
Available from URL:
http://www.hc-sc.gc.ca

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