Restrictions for lumiracoxib in wake of liver concerns
New contraindications and monitoring advice for lumiracoxib
(Prexige) have been issued by Novartis, the drug's manufacturer.
Last month, lumiracoxib was withdrawn in Australia in the wake of reports
of liver-
related side effects (PJ, 18 August, p174). Following consultation with
the Medicines and Healthcare products Regulatory Agency and the European
Medicines Agency, Novartis has written to UK health care professionals
advising them of new restrictions to the prescribing of lumiracoxib which
have been incorporated into the drug’s summary of product characteristics.
The letter also reminds health care professionals that treatment should
be limited to the shortest duration necessary and that the dose should
not exceed 100mg daily.
Lumiracoxib is now contraindicated for patients who have any current
hepatic disease, prior drug-induced significant elevations of transaminases,
or liver transaminases above 1.5 times the upper limit of the normal
range (ULN) before treatment, or three times ULN during treatment and
for patients who are taking other medicines associated with clinically
significant hepatotoxicity.
Novartis is also recommending that liver function tests (LFTs) be performed
before starting treatment and once a month during treatment, and that
the tests should be repeated after seven days if transaminases are above
two times ULN. In addition, patients reporting any systemic illness while
taking lumiracoxib should be given LFTs.
Patients who are taking lumiracoxib and feel unwell (with, for instance,
nausea, vomiting, loss of apetite, tiredness, stomach pains, dark urine,
jaundice) should stop taking lumiracoxib and arrange to see their doctor
as soon as possible to have a precautionary blood test.
Patients who
are taking lumiracoxib and feel well should continue their treatment,
but arrange an appointment with their doctor at the end of the current
course of tablets to discuss their treatment. |
The
Pharmaceutical Journal
Acrobat
Reader