Summary
Arcoxia is the successor drug to Merck's withdrawn Vioxx painkiller product, and it appears to have problems with heart conditions, according to federal regulators. Regulators believe that Arcoxia, like Vioxx, exacerbates heart problems. Arcoxia is a COX-2 inhibitor, a family of drugs that is coming under fire as links to heart conditions, strokes and even death become more well-defined.
Original source:
http://www.healthtalk.ca/merck_vioxx_successor_020605_39933.php
Details
Arcoxia, Merck's successor to Vioxx appears to be worse than other painkillers when it comes to cardiovascular problems and deaths, according to documents released Friday by U.S. Food and Drug Administration staff reviewers.
U.S. regulators based their initial findings on studies conducted by Merck that compared Arcoxia with placebo, naproxen and other nonsteroidal anti-inflammatory drugs or NSAIDs.
Arcoxia like Vioxx is part of a family of drugs called Cox-2 inhibitors.
The drugs were developed to reduce the incidence of GI bleeding while also providing effective pain relief for arthritis patients.
Merck voluntarily withdrew Vioxx from the market in September after a clinical trial showed it doubled the risk of heart attacks and strokes.
Since September, the entire class of Cox-2 inhibitors, including Pfizer's Celebrex and Bextra, have been linked to increased heart risks in various trials.
More than 700 class action lawsuits have been launched against Merck over heath risks associated with Vioxx since the drug was pulled from the market.
Later this month, the FDA will hold a meeting of the agency's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the overall benefit-to-risk considerations for COX-2 selective non-steroidal anti-inflammatory drugs (NSAIDs) and related medicines.
The outcome will likely determine the future of Cox-2 inhibitors in the US.
Some groups in the U.S. are pushing for a total ban on drugs once described as "super aspirin."
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Sunday, February 13, 2005
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