EMEA to withdraw lumiracoxib approval
The European Medicines Agency (EMEA) has recommended the withdrawal of marketing authorizations for all lumiracoxib-containing products due to concerns about the risk of serious liver side effects. At present the agent, which was granted European marketing approval in 2005 (Marketletters passim) for the symptomatic relief of osteoarthritis, is sold under the Prexige, Stellige, Hirzia and Frexocel brand names by Swiss drug major Novartis.
The announcement follows the Australian Therapeutic Goods Administration's decision to withdraw marketing authorization for Prexige after reports of serious liver events earlier in the year (Marketletter August 13). Since then, the product has been the subject of a Health Canada review over similar safety concerns (Marketletter September 3), while its sale has been suspended by regulators in the UK and Germany (Marketletter November 26).
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