COX-2 Woes May Provide Respite For Drugs Frequently Targeted In Litigation
This article was originally published in The Pink Sheet Daily
The uproar over COX-2 inhibitors may provide an upside for other drugs that are longstanding litigation targets, such as Lilly's atypical antipsychotic Zyprexa
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The Adenoma Prevention with Celecoxib trial found an increased CV risk for patients taking 400 mg and 800 mg Celebrex compared to placebo; a second study showed no increased risk. The APC study results mean Pfizer can no longer promote the COX-2 as being clear of cardiovascular signals.
Labeling change to add "black box" for serious skin reactions incorporates post-surgery safety data, including results from two coronary artery bypass graft trials that show increased cardiovascular risk with Pfizer's COX-2 inhibitor.
Arcoxia's user fee date is Oct. 30, but FDA could decide to wait for 18-month cardiovascular safety data from a 20,000-patient trial comparing etoricoxib with diclofenac. Merck says it will work with regulatory authorities in 47 countries where Arcoxia is marketed to discuss potential labeling changes resulting from the Vioxx study data.