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News From the Food and Drug Administration
September 13, 2000

Revised Labeling for Zanamivir

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JAMA. 2000;284(10):1234. doi:10.1001/jama.284.10.1234-JFD00007-3-1

The FDA has added important new safety information to the labeling for zanamivir for inhalation (Relenza, Glaxo Wellcome Inc, Research Triangle Park, NC). Zanamivir was approved in July 1999 for treatment of uncomplicated acute illness due to influenza virus.

Original labeling for this drug included information about bronchospasm and decline in lung function and about lack of demonstrated efficacy in patients with underlying respiratory disease such as asthma or chronic obstructive pulmonary disease. Revised labeling adds a warning that zanamivir is not generally recommended for patients with underlying airways disease because of the risk of serious adverse events. Some deaths have been reported through the Adverse Events Reporting System among patients taking zanamivir, although the reasons have not been determined.