Two batches of Novartis' Fluad taken off market for investigation in Italy after 13 deaths

1 December 2014

The Italian Medicines Agency (AIFA) has suspended two batches of Swiss drug major Novartis’ (NOVN: VX) Fluad seasonal flu vaccine following 13 deaths in regions across Italy of elderly patients taking the drug. The suspension was particularly triggered by two batches being linked to at least eight of those 13 deaths, and one ‘serious adverse event’.

The European Medicines Agency is calling it a “precautionary measure,” and said there is no evidence so far to support any causal link between Fluad and the reported adverse events. This has been echoed by Novartis in its statement. The company added that Fluad has demonstrated a “robust” safety history since coming to the market in 1997, and that upon examining the two batches, found them to conform with quality and production standards.

The AIFA are conducting their own tests on the batches.

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