Onsenal▼ (Celecoxib) withdrawn from EU market

Onsenal▼ (celecoxib) is no longer approved in Europe for the reduction of intestinal polyps in familial adenomatous polyposis (FAP).

Article date: August 2011

Onsenal▼ withdrawal

Celecoxib is a non-steroidal anti-inflammatory drug and cyclo-oxygenase type 2 inhibitor, which is approved for the treatment of symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Until recently, celecoxib was also authorised as the orphan drug Onsenal▼ for the reduction of intestinal polyps in familial adenomatous polyposis. At the time of approval of Onsenal▼, the licence (marketing authorisation) holder committed to do post-authorisation clinical studies.

However, failure to recruit sufficient numbers into a clinical trial designed to provide evidence relating to clinically important benefit has resulted in the licence holder voluntarily withdrawing Onsenal▼.

European review of celecoxib in FAP

The European Medicines Agency has reviewed the available data after concerns that celecoxib may continue to be used unlicensed in the treatment of FAP. The review concluded that the clinical benefit of celecoxib in FAP has not been sufficiently demonstrated and is outweighed by the increased risk of cardiovascular and gastrointestinal side effects from celecoxib use at high dose and long term in patients with FAP.

Advice for healthcare professionals:

  • celecoxib is not recommended for the reduction of intestinal polyps in FAP and should not be prescribed for this unlicensed indication
  • patients who are taking Onsenal▼ should consult their doctor as soon as possible to discuss alternative treatment options

Call for reporting

Please report suspected adverse reactions through the Yellow Card Scheme at www.yellowcard.gov.uk. When reporting please provide as much information as possible, including information about medical history, any concomitant medication, onset, and treatment dates.

Further information

See letter for healthcare professionals sent April 2011

European Medicines Agency statement on Onsenal withdrawal

European Medicines Agency conclusion on use of celecoxib in FAP

Article citation: Drug Safety Update vol 5 issue 1, Aug 2011: A2.

Updates to this page

Published 11 December 2014