Speaking of pediatric safety, the FDA also plans to review Roche's Tamiflu and GlaxoSmithKline's Relenza at its advisory committee confab Nov. 27-28. At issue: the anti-influenza drugs' potential neurological side effects in kids.
The FDA started looking at the neurological effects of these drugs in 2005, when it began receiving reports of hallucinations and convulsions. Twenty-five kids have died while on Tamiflu, most of them in Japan, where regulators restricted usage of the drug in teens, sending sales of the drug in all age groups tumbling. There have been no reports of Relenza-related deaths, but regulators say the drug causes similar neurological side effects.
The agency is recommending a change to the drugs' labeling to alert doctors about these possible side effects. But Roche says there's no evidence to link the deaths with Tamiflu, and that flu patients have exhibited similar symptoms without the help of the drug. More than 1,700 of the 1,808 adverse-event reports originated in Japan, a company spokesman said, and 81 percent of those were "non-serious." It's worth noting, though, that Japan has been the biggest market for the drug, where 75 percent of the prescriptions for it are written.
Tamiflu's Japanese sales to drop by half. Report
Roche's Tamiflu ads spark criticism. Report
EU approves Tamiflu for children. Report