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Withdrawal Of Onsenal And Risks Of Lei Gong Teng Highlighted In Latest DSU

Onsenal (celecoxib) is no longer approved in Europe for the reduction of intestinal polyps in familial adenomatous polyposis (FAP) and, because of a lack of safety data, should not be prescribed for this unlicensed indication, the latest Drug Safety Update reports.

Onsenal was approved as an orphan drug for the reduction of intestinal polyps on the condition that Pfizer, its marketing authorisation holder, provided evidence of its benefits through post-authorisation clinical studies. However, according to the DSU, not enough patients were recruited into the trial so Pfizer voluntarily withdrew Onsenal from the market.

The European Medicines Agency has 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.

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Extract taken from PJ Online