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What is the story here?
The Food and Drugs Administration (FDA) has issued a ‘not approvable‘ letter for lumiracoxib (Prexige®) according to a press release from the manufacturer. PharmaTimes has also reported this story.
Why has this happened?
This rejection follows shortly after the Medicines and Healthcare products Regulatory Agency (MHRA) issued interim advice restricting the use of lumiracoxib following the withdrawal of the drug in Australia by the Therapeutic Goods Administration (TGA). as a result of concerns over liver safety. The TGA (the Australian equivalent of the American FDA and the British MHRA) received eight reports of serious liver adverse reactions associated with use of lumiracoxib in 6 months. These reports included two fatalities and two patients requiring liver transplants.
Following consultation with the MHRA and other European regulators, Novartis, the manufacturer of lumiracoxib, sent a letter to healthcare professionals advising that the drug is now contraindicated in patients:
- with any current hepatic disease
- with prior drug-induced significant (>3x Upper Limit of Normal [ULN]) elevations of transaminases
- with liver transaminases >1.5xULN before treatment, or >3xULN during treatment
- taking other medicines associated with clinically significant hepatotoxicity
In addition, monitoring of liver function (LTFs) is recommended as follows:
- Perform baseline LFTs before starting treatment (see third contraindication above)
- Repeat LFTs monthly during continued treatment
- Stop treatment if transaminases >3xULN, repeat in 7 days if transaminases >2xULN
- Conduct LFTs for patients reporting any systemic illness whilst taking lumiracoxib.
There have been no reported fatalities in the UK linked to lumiracoxib perhaps because it has not been widely used; the MHRA estimates that around 5,400 patients have been prescribed lumiracoxib in the last year in the UK compared to over 7 million patients globally since launch in July 2005. European Regulatory Authorities may amend this advice following a full review of the risks and benefits of lumiracoxib this month.
Further information on the safety of Cox-II inhibitors and non-selective non-steroidal anti-inflammatory drugs is available on the MHRA website.
Bottom Line:
Clinicians should be aware of the continued concerns about this drug. Lumiracoxib has a very limited place in therapy. It would be prudent to review any current prescriptions for this drug and perform liver function tests in any patients who are taking or have recently taken lumiracoxib.
This article is based on blogs by Matt Robinson which can be accessed at http://www.prescriber.org.uk/2007/09/28/lumiracoxib-not-approved-by-fda/