Print this page

Vioxx successor denied approval by FDA Advisory Panel

The proposed successor of the banished arthritis painkiller, Vioxx, was soundly rejected by the United States Food and Drug Administration's Arthritis Advisory Committee by a vote of 20 to 1 during yesterday's hearing.

Expressing concern over the cardiac safety of the new prescription drug, Arcoxia, the panel of medical experts recommended against FDA approval. A storm of criticism preceded the Committee's hearing yesterday because of Arcoxia's potential for increasing heart attacks and strokes, particularly among people with existing heart disease.

FDA scientist Dr. David Graham testified before the panel stating that the drug safety studies done on Arcoxia were neither adequate nor reasonable to support its approval. "What you're talking about is a potential public safety disaster," Graham said of Arcoxia. "We would have a replay of what we had with [Vioxx]."

The Medal study, conducted by Merck, included results from three clinical trials comparing Arcoxia to diclofenac, an older painkiller. The study indicated that on average patients who took Arcoxia were slightly less likely to have heart attack or other serious cardiovascular problem than those who took diclofenac, according to Merck.

However, patients on Arcoxia were significantly more likely to have hypertension or swelling, Merck said. Hypertension is a particularly troubling side effect, doctors said, because it is associated with heart attacks and congestive heart failure.

Another expert, Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, a consumer protection group, said that Arcoxia should not be approved in the United States and should be pulled of the market in the more than 60 countries where it is now sold, which includes Ireland.

Arcoxia, made by Merck & Co., is a cox-2 inhibitor designed to treat the pain of osteoarthritis without the stomach effects associated with other painkillers such as aspirin. Arcoxia was approved and has been available in Ireland since December 2002.

Sources: 12th April 2007, Washington Post, 24th August 2006, New York Times, and U.S. Food and Drug Administration.

Seeking Health Law Advice

For further information and advice regarding your legal rights and entitlements, please contact Malcomson Law by calling 01 8744422 or complete an Online Enquiry Form. Your enquiry will be forwarded to a solicitor who specialises in Medical Negligence.

This news section contains stories of interest from publicly available news sources. Where we are representing the clients referred to in the news material we will say so. Where we do not represent individuals or bodies mentioned or quoted, the inclusion of the news story in our news section is not intended nor should it be taken to imply that we act for the individual or body concerned.