lumiracoxib (Prexige) and the liver
admin September 3rd, 2007
Following consultation with the MHRA and other European regulators, the manufacturer of the osteoarthritis drug lumiracoxib (Prexige), is writing to health professionals to inform them of new restrictions on the prescribing of lumiracoxib. 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 new measures include regular liver monitoring for patients taking lumiracoxib. In addition, lumiracoxib should not be used in patients with current liver disease or those thought to be at possible risk because of their previous history or other medicines.
The balance of risks and benefits of lumiracoxib in the treatment of osteoarthritis will be further evaluated by European Regulatory Authorities in September. Any updated advice will be issued following that evaluation.
- ADRs , EMEA , MHRA
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