Arcoxia Rejected By FDA Arthritis Advisory Committee

Thursday April 12, 2007

Arcoxia (etoricoxib) was not recommended for approval today by the FDA Arthritis Advisory Committee. According to MSNBC, the committee voted 20-1 against arthritis drug Arcoxia, a COX-2 inhibitor which has been in development by Merck, the maker of Vioxx. An FDA spokesman reported that the committee had concerns over cardiovascular safety of Arcoxia and with all drugs in the COX-2 inhibitor class of drugs. The concern over COX-2 inhibitor safety became public knowledge when Vioxx was withdrawn from the market in September 2004 after being linked to an increased risk of heart attacks and strokes.

The committee ultimately felt that potential risks associated with Arcoxia were substantial and that proof did not exist that the drug is more effective than medications already available. Merck still believes Arcoxia would be beneficial for treating signs and symptoms associated with osteoarthritis and the drug would expand treatment options. Merck claims Arcoxia was comparable to an older NSAID (nonsteroidal anti-inflammatory drug) diclofenac based on a study which involved 35,000 patients. However, it was determined that Arcoxia caused more high blood pressure than diclofenac. Critics believe it would have been a superior study if Arcoxia was compared to naproxen rather than diclofenac.

Arcoxia is sold in 63 countries, but is not approved in the United States. The battle to gain FDA approval for Arcoxia has been opposed by many who fear a replay of the Vioxx situation. The FDA is not required to follow the recommendations of the Arthritis Advisory Committee but usually does.

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