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Onsenal - a non-steroidal anti-inflammatory drug and cyclo-oxygenase type 2 inhibitor approved for the management of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis symptoms and previously also authorized as an orphan drug Onsenal for reducing intestinal polyps in Familial Adenomatous Polyposis FAP - is now removed from the European market due to a lack of sufficient evidence supporting its clinical benefits.
Onsenal was initially approved on account of the licence holder's commitment to conducting post-approval trials med at providing data relevant to significant therapeutic benefit. However, due to difficulties in recruiting enough participants for this study, which med to demonstrate clinically meaningful advantages, the manufacturer has voluntarily withdrawn Onsenal from the market.
The European Medicines Agency EMA has reviewed avlable clinical evidence on celecoxib's use in FAP patients following concerns about potential unlicensed usage of the drug. This review concluded that although the benefits of celecoxib are not adequately demonstrated in this context, they are outweighed by increased risks associated with cardiovascular and gastrointestinal adverse effects from prolonged high-dose usage.
Key Information for Health Care Professionals:
Onsenal is no longer recommed or prescribed for reducing polyps in FAP patients due to its unlicensed status.
Patients currently taking Onsenal should consult their healthcare provider immediately to discuss alternative therapeutic options.
Please report suspected side effects promptly using the Yellow Card Scheme at www.yellowcard.gov.uk. In your submission, ensure you provide comprehensive detls including medical history, concurrent medication use, onset timing and duration of treatment.
Further Information:
Refer to the April 2011 letter for healthcare professionals detling this update.
See statement on Onsenal's withdrawal from European Medicines Agency
Find EMA on celecoxib usage in FAP
Citation:
Drug Safety Update Volume 5 Issue 1, August 2011: Article A2.
Content Updates
Published December 11, 2014.
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This article is reproduced from: https://www.gov.uk/drug-safety-update/onsenal-celecoxib-withdrawn-from-eu-market
Please indicate when reprinting from: https://www.p092.com/Drug_capsules/Eurosime_Celecoxib_WD_for_FAP.html
Onsenal Withdrawal Europe FAP Treatment Celecoxib Risk Assessment Adenomatous Polyposis Non steroidal Anti inflammatory Drug Market Removal Post Approval Trials Clinical Benefit Evidence Orphan Drug Status Familial Adenomatous Polyposis EMA Review Cardiovascular Gastrointestinal Effects