Lumiracoxib withdrawn in Australia due to safety concerns
Lumiracoxib (Prexige), a COX-2 selective inhibitor used for the treatment of osteoarthritis, has been withdrawn
in Australia due to liver-related side effects. Lumiracoxib is licensed in the UK and a European level review of the evidence in relation to liver reactions is currently under way. The outcome of the review is expected in September 2007.
The Australian regulatory authority, the Therapeutic Goods Administration,
has deregistered the drug following eight reports of serious liver adverse
reactions, two of which were fatal and two of which required liver transplants.
All reports have been received since March. Some patients’ conditions
have not improved since stopping lumiracoxib.
The Medicines and Healthcare products Regulatory Agency has highlighted
that the majority of cases of serious liver reactions with lumiracoxib
have been associated with higher doses than those licensed in the UK
and EU. “We are not aware of any fatal cases of liver toxicity
in the EU,” it added. The MHRA advises that if patients feel unwell
or are concerned they should speak to their doctor or pharmacist.
A statement issued by Novartis, manufacturer of Prexige, said: “Novartis
is collaborating with TGA; however, we continue to believe that the way
in which lumiracoxib is used in the UK has a positive benefit/risk profile
in the treatment of appropriate patients, especially those at risk of
serious gastrointestinal side effects.”
Viracept Following the recall
of Viracept (nelfinavir) from the EU market in
June (PJ, 16 June, p694) because of concerns about contamination with
a genotoxic
substance, the European Commission has suspended the drug’s marketing authorisation.
The suspension can only be lifted after assessment of new data by the European
Medicines Agency. |
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