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

FDA reject etoricoxib for OA

The Food and Drugs Administration (FDA) has issued a Non Approvable Letter for etoricoxib (Arcoxia®) in osteoarthritis (OA) according to the manufacturer's website.

Etoricoxib is a Cox-II selective non-steroidal anti-inflammatory that is available and licensed in the UK for osteoarthritis, rheumatoid arthritis and gout. The FDA rejected the application for a licence in OA and requested additional data in support of the benefit-to-risk profile.

Action: Etoricoxib is licensed for OA in the UK, however it may be prudent to restrict use of this drug in OA based on the cautious approach taken in America.