Prexige licence suspended after liver damage cases
MHRA advice for patients
• Patients who are feeling unwell — eg, with vomiting, loss
of appetite, stomach pains, dark urine or jaundice — should
stop taking lumiracoxib and see their doctor immediately
• Well patients whose pain is not too bad should ideally stop taking
the drug and see their doctor to discuss alternative treatment
• Patients for whom lumiracoxib is providing important relief could
continue taking the drug until it is convenient to see the doctor
• Any unused lumiracoxib tablets should be returned to the pharmacy
or GP surgery |
Pharmacists have been advised this week not to dispense Novartis’s lumiracoxib (Prexige) and to return the product to their supplier following suspension
of the product’s marketing authorisation by the Medicines and Healthcare products Regulatory Agency.
The selective cyclooxygenase-2 inhibitor, used as an anti-inflammatory
for patients with osteoarthritis of the knee and hip, has had its UK
licence suspended on the advice of the MHRA’s Commission on Human
Medicines due to concerns about possible liver damage.
Licensing of lumiracoxib
was withdrawn
fully in Australia earlier this year (PJ, 18 August
2007, p174).
Based on its review of evidence, the CHM claimed that urgent action was
required to protect public health. “The latest evidence on cases
of serious hepatotoxicity includes several new cases reported with the
100mg daily dose licensed in the EU. In some cases, serious hepatotoxicity
occurred after less than one month of treatment,” the CHM said.
Doctors have been told to stop prescribing the drug.
According to the MHRA, there have been 20 case reports of severe liver
reactions worldwide suspected to be at least possibly related to lumiracoxib
use, including 14 cases of liver failure. Two of these cases resulted
in death and three patients required a liver transplant. Around 8.5 million
lumiracoxib prescriptions have been written worldwide since the drug’s
launch in 2005.
The MHRA will wait for the results of a European review
by the European Medicines Agency’s Committee for Medicinal Products
for Human Use, expected in December, before deciding on lumiracoxib’s
future in the UK.
Novartis is ceasing distribution of Prexige to wholesalers immediately
and is asking pharmacists to contact their wholesaler to arrange product
returns. Nevertheless, the company said this week in a statement: “Prexige
is an important treatment option with a positive benefit/risk ratio when
used in appropriate patients.” |
The
Pharmaceutical Journal
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