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| Antiviral labels updated |
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4 March, 2008Roche and GlaxoSmithKline (GSK) have added new labels to their prescription antiviral medications, oseltamivir (marketed in Australia as Tamiflu) and zanamivir( marketed in Australia as Relenza), which now contain a warning about cases of delirium and unusual behaviour in some patients. The revised contain more descriptive information about neuropsychiatric events related to influenza in general; however, the labels also highlight that no contribution by oseltamivir and zanamivir to these events has been established. The changes come in the wake of reports of adverse effects, mostly seen in Japan, and Roche and GSK note that the revisions labels reflect recommendations made in November 2007 by a U.S Food and Drug Administrator (FDA) advisory panel. Australia's Therapeutic Goods Administration (TGA) said labels had been updated in line with U.S changes .However a TGA spokewoman confirmed no deaths and only one adverse reaction had been reported in Australia in the past two years. A recent study in the USA found no increase in neuropsychiatric events in patients prescribed Oseltamivir (1). 1. Blumentals WA, Song X.The saftey of oseltamivir in patients with influenza: analysis of healthcare claims data from six influenza seasons. MedGenMed 2007;9(4):23 Content Updated (Thursday, 20 March 2008) |