WHO Pharmaceuticals Newsletter 2005, No. 03
(2005; 17 pages) View the PDF document
Table of Contents
Close this folderRegulatory Matters
View the documentAlbumin - Safety issues in critically ill patients
View the documentAntiretroviral agents - Caution advised against certain combinations
View the documentAtypical Antipsychotics - Risk of death in elderly patients with dementia
View the documentCyclo-oxygenase-2 (COX-2) Inhibitors - To be available under strict restrictions
View the documentCyproterone acetate and ethinylestradiol - Not to be used in contraception
View the documentDonepezil - Warning of rhabdomyolysis
View the documentDrotrecogin alfa (activated) - Only for use in high-risk patients
View the documentEfavirenz - Reports of neural tube defects
View the documentEfalizumab - Immune mediated haemolytic anaemia
View the documentGalantamine - Death in subjects with mild cognitive impairment
View the documentHydromorphone hydrochloride - To be withdrawn for safety reasons
View the documentLepirudin - Information on dosage and administration
View the documentMitoxantrone - Label to reflect risks of cardiotoxicity
View the documentNSAIDs - Black box warning for both prescription and OTC products
View the documentOxcarbazepine - Label to include serious dermatological reactions
View the documentParoxetine and Pimozide - Concurrent use contraindicated
View the documentPhenyl-propanolamine - Suspended while adverse reaction reports are reviewed
View the documentSildenafil, Tadalafil, Vardenafil - Labels updated with NAION information
View the documentValdecoxib - Sales suspended in more countries
View the documentVeralipride - Suspended due to neurological and other adverse reactions
Open this folder and view contentsSafety of Medicines
Open this folder and view contentsMISCELLANY
 

Efalizumab - Immune mediated haemolytic anaemia

USA. Genentech has issued a new warning regarding events of immune-mediated haemoltyic anaemia associated with efalizumab-use, indicated in the treatment of severe plaque psoriasis in adult patients (18 years or older). According to Genentech, two cases of haemolytic anaemia were observed in efalizumab (Raptiva) clinical trials; two additional cases were reported in the postmarketing setting. In its letter to health-care providers Genentech has stated that a causal relationship between efalizumab (Raptiva) and these events has not been established but cannot be excluded and that health-care providers should discontinue treatment if haemolytic anaemia occurs.

Reference:

'Dear Health-care Provider' letter from Genentech, Inc., July 2005 (http://www.fda.gov).

 

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Last updated: May 3, 2013