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View the documentHydromorphone hydrochloride - To be withdrawn for safety reasons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
 

Antiretroviral agents - Caution advised against certain combinations

Canada. Bristol-Myers Squibb Canada and Gilead Sciences have issued a 'Dear Health-care Professional' letter to highlight that new clinical data show the potential for drug interactions between didanosine (delayed- release capsules enteric coated beadlets, Videx EC) and tenofovir disoproxil fumarate (Viread), with or without efavirenz (Sustiva) or nevirapine (Viramune). According to reports from recent investigator-sponsored studies, the coadministration of tenofovir and didanosine with either efavirenz or nevirapine may be associated with a potentially high virological failure rate and emergence of resistance in antiretroviral-näive adults with HIV-infection, low CD4+ cell counts and high baseline viral loads. Results of pharmacokinetic studies show that tenofovir and didanosine coadministration increases systemic didanosine exposure by 40 60%, and could potentiate didanosine-related adverse events (AEs). The companies recommend that the coadministration of didanosine and tenofovir be undertaken with caution, that patients who are receiving both drugs be monitored carefully for continued efficacy and for AEs, and that didanosine be discontinued in patients who develop AEs associated with the drug. The companies advise that the Canadian didanosine (Videx EC) and tenofovir disoproxil fumarate (Viread) product monographs have been revised to include this information, along with recommended didanosine dosage adjustments for coadministration with tenofovir.

Reference:

'Dear Health-care Professional' letter from Bristol Myers Squibb and Gilead Sciences, Canada, 9 June 2005 (http://www.hc-sc.gc.ca).

to previous section to next section
 

Last updated: May 3, 2013