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Biosecurity Briefing
FDA Panel Votes for Stronger Warnings on Flu Drugs By Kunal Rambhia, November 30, 2007 On November 27, 2007, the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota reported that the Food and Drug Administration’s (FDA) Pediatric Advisory Committee voted to recommend stronger language on warning labels of two antiviral flu medications, oseltamivir (brand name Tamiflu®) and zanamivir. This decision is based on the committee’s review of adverse neuropsychiatric events among children and teens and calls upon the FDA to require that manufacturers of these drugs include labels warning that several patients died as a result of these events. In 2006, the FDA Pediatric Advisory Committee stated that “it would monitor adverse-event reports over the next two flu seasons to determine if further precautions are needed.”1 Since then, oseltamivir manufacturer Roche has included a warning label regarding neuropsychiatric events; if the FDA were to accept the 2007 recommendations of its advisory committee, Roche would be required to strengthen the warning language on its packaging. Zanamivir is not currently sold with a warning label. On November 27, 2007, the Associated Press (AP) reported that Roche asserts the evidence does not support a link between the drug and “increased risk of psychiatric problems.”2 Citing a company study of 150,000 patients, Roche maintains that the influenza virus, not the drug, is to blame for these adverse symptoms. GlaxoSmithKline (GSK), maker of the zanamivir drug Relenza, also disagrees with the committee’s findings, noting that none of the 145 neuropsychiatric cases reported in association with Relenza was fatal. Neither company believes “the evidence warrants labeling changes.”1 However, in a November 28, 2007, AP report, a Roche spokesperson said that the company will accept the recommendation of the advisory committee. Since its release in 1999, oseltamivir has been administered to 48 million patients. A total of 600 cases of psychiatric events have been reported, mostly among children and teens. Japan, which “accounts for two thirds of the $2.4 billion global market for Tamiflu® because doctors there almost always prescribe drugs to treat flu symptoms,” has reported 21 out of the 25 deaths involving psychiatric events.2 The remaining deaths were reported in the United States (n=3) and Egypt (n=1). The FDA has monitored adverse events associated with oseltamivir use since self-injury and delirium were first reported among Japanese patients in 2005.2 References
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