ZURICH (Reuters) - Swiss drugmaker Novartis AG has informed doctors in Europe of new restrictions on prescribing lumiracoxib, its COX-2 inhibitor sold under the trade name Prexige, including regular liver monitoring, Britain’s drug regulator said.
In a letter to doctors, Novartis also said Prexige should not be used in patients with current liver disease or those thought to be at possible risk because of their history or other medications, the UK Medicines and Healthcare Products Regulatory Agency said in a statement.
“Concern was raised worldwide after rare reports of serious liver reactions; mostly relating to daily doses that are higher than licensed in the EU,” the statement said.
European regulatory authorities will further assess the balance of risks associated with use of Prexige in September, the agency said.
Australia’s drugs regulator has banned the use of Prexige because of liver problems, including two deaths and two liver transplants.
Prexige, which had modest sales of $52 million in the first half of the year, is approved in more than 50 countries and is currently being rolled out in Europe, though it is yet to get the green light in the United States.
COX-2s have been under a cloud since the withdrawal of Merck & Co. Inc.’s Vioxx in 2004 after studies found it raised heart attack risk, and there have also been worries about other NSAIDs.