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).

The EMEA's Committee for Medicinal Products for Human Use (CHMP) concluded at its December meeting that the benefits of products containing lumiracoxib are outweighed by their risks. This followed a Europe-wide review of safety that was initiated after reports of serious liver injury in UK patients treated with lumiracoxib-based agents. The committee also said that proposals to limit use of such drugs to the short-term were not likely to reduce the risk of liver reactions given the long-term nature of the indication for which such drugs are approved.