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View the documentHydromorphone hydrochloride - To be withdrawn for safety reasons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
 

Veralipride - Suspended due to neurological and other adverse reactions

Spain. Effective June 2005, the Spanish Agency for Medicines and Medical Devices has suspended the marketing authorization for veralipride (Agreal) in Spain. This action is based on the conclusions of the Spanish Medicines Safety Committee that reviewed reports of psychiatric and neurological disorders and of withdrawal symptoms associated with veralipride use. The Agency has released a press statement on its website and has communicated this information to all health professionals in the country.

Reference:

Communicaçión. Agencia Espanola de medicamentos (Agemed), 20 May 2005 (http://www.agemed.es).

 

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Last updated: May 3, 2013