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View the documentHydromorphone hydrochloride - To be withdrawn for safety reasons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

Albumin - Safety issues in critically ill patients

USA. The United States Food and Drug Administration (FDA) has revised its previous advice on the safety of albumin administration to patients who are critically ill, following a review of recent studies. In 1998, following the publication of a meta-analysis by the Cochrane Injuries Group, the FDA had expressed 'serious concern' about the safety of albumin administration to patients who were critically ill. The study had found that the relative risk of dying was higher with albumin than with normal saline administration in such patients; the findings were similar for patients with hypovolaemia, burns and hypoproteinaemia. In March 2005, the Blood Products Advisory Committee (BPAC) voted that the results of a randomised controlled trial (the SAFE study: Saline versus Albumin Fluid Evaluation, N Engl J Med 2004;350:2247-56), resolved the prior safety concerns raised in the Cochrane meta-analysis; in the SAFE study, the mortality rate for patients in the general ICU population was the same for those who received albumin as for those who received saline for fluid resuscitation. The FDA states that the revision of its advice is consistent with the BPAC recommendations. However, as patients with burns were excluded from the SAFE study, the relative safety of albumin cannot be determined for this group.


Safety of albumin administration in critically ill patients. United States Food and Drug Administration, 16 May 2005 (http://www.fda.gov).


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