Pfizer Delays European Launch of Cox-2 Drug Onsenal

Amid the growing uncertainty about the safety of Cox-2 inhibitors, Pfizer has agreed to delay the European launch of Onsenal, a Cox-2 drug approved in the EU for the treatment of intestinal polyps.

The European Medicines Agency (EMEA) has confirmed that Pfizer's launch of Onsenal (celecoxib) will be put on hold until the agency can complete its ongoing safety assessment of Cox-2 inhibitors. Onsenal contains the same active ingredient, but at a higher dose, as Pfizer's pain drug Celebrex (celecoxib), which research has shown may pose cardiovascular risks. The European Union (EU) granted Pfizer marketing approval for Onsenal in 2003, but the drug has yet to be launched.

"Pfizer agreed to temporarily delay the launch of Onsenal in order to update the drug's label with any changes that might result from the EU's review of Cox-2 medicines," a Pfizer spokeswoman said.

EMEA requested Onsenal's launch be delayed after its Committee for Medicinal Products for Human Use held a hearing with Pfizer to discuss Cox-2 safety issues. Merck, which sells the Cox-2 drug Vioxx (rofecoxib), and Novartis, maker of Cox-2 inhibitor Prexige (lumiracoxib), also participated in the hearing. The hearing was part of a formal assessment of Cox-2s that EMEA initiated in October 2004 after Merck voluntarily recalled Vioxx due to safety concerns.

EMEA said that the committee has yet to finish its assessment and will continue its discussions on the safety review at a Feb. 14-17 meeting.