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Etoricoxib CV Risks

Posted by Larry1 on 15 Feb 2013 at 05:30 GMT

The article by McGettigan and Henry’s is a valuable contribution for those making drug approval decisions particularly in low and middle-income countries that may have limited resources at their disposal to review new drugs.

Specifically, regarding etoricoxib that was ranked high in cardiovascular risk. The FDA’s review of the etoricoxib New Drug Application (FDA) was made available to the public prior to a joint meeting of the Arthritis Drug and Drug Safety and Risk Management Advisory Committees held in mid-February 2005. The FDA reviewer wrote in the conclusion: “Data from the NDA suggests a CV safety signal. This is present whether etoricoxib is compared to naproxen or non-naproxen NSAIDs.”[1]

The advisory committee voted 20 to 1 against approving etoricoxib because of the drug’s cardiovascular risks.[2] Etoricoxib was not approved in the US.

Unfortunately, drugs rejected in the US for safety reasons can be marketed in other countries. At the time etoricoxib was denied US marketing authorization it was estimated it had been approved in 60 other countries.

Colleagues in low and middle-income countries can obtain FDA advisory committee briefing documents for free on the agency’s Web site. Also, the financial press makes extensive use of FDA briefing documents and the financial press can be a valuable source for identifying potential safety problems with new drugs.

Larry D. Sasich, PharmD, MPH, FASHP
Consultant, Saudi Food and Drug Authority
Riyadh, Saudi Arabia


1. US Food and Drug Administration – Briefing Documents for the Arthritis Drugs and Drug Safety and Risk Management Advisory Committee, February 16-18, 2005. Available at: Accessed February 15, 2013.

2. Harris G. F.D.A. Panel Rejects Merck Pain Pill in 20-1 Vote. New York Times, April 12, 2007.

No competing interests declared.