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View the documentHydromorphone hydrochloride - To be withdrawn for safety reasons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
 

Sildenafil, Tadalafil, Vardenafil - Labels updated with NAION information

USA. The FDA has notified health-care professionals of updated labelling for tadalafil (Cialis), vardenafil (Levitra) and sildenafil (Viagra) to reflect a small number of postmarketing reports of sudden vision loss, attributed to a NAION (non arteritic ischaemic optic neuropathy), a condition where blood flow is blocked to the optic nerve. All three preparations are indicated in the treatment of erectile dysfunction in men. The FDA advises patients to stop taking these medicines, and call a doctor or health-care provider right away if they experience sudden or decreased vision loss in one or both eyes. Patients taking or considering taking these products should inform their health-care professionals if they have ever had severe loss of vision, which might reflect a prior episode of NAION. Such patients are at an increased risk of developing NAION again. At this time, it is not possible to determine whether these oral medicines for erectile dysfunction were the cause of the loss of eyesight or whether the problem is related to other factors such as high blood pressure or diabetes, or to a combination of these problems.

Reference:

FDA Statement. United States Food and Drug Administration, 8 July 2005 (http://www.fda.gov).

 

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