- Prescribing Advice for GPs - https://www.prescriber.org.uk -

Lumiracoxib not approved by FDA

The Food and Drugs Administration has issued a 'not approvable' letter for lumiracoxib (Prexige®) according to a press release from the manufacturer. PharmaTimes have also reported this story.

This rejection follows shortly after withdrawal of the drug in Australia, announcement of a full review of the drug in Canada and restrictions on use in Europe.

Action: Clinicians should be aware of the continued concerns about this drug. Patients on existing treatment should be changed to safer alternatives where possible.