FDA Says No to Vioxx Successor

Related Encyclopedia • Acidophilus • Alzheimer's Disease • Aneurysms • Angina Pectoris More... Related Healthscout Videos Howard: The Helping Hand for Stroke Survivors Fixing Torn Hearts Medicine's Next Big Thing? Growing Hearts How can a supportive family help? More... Related Animations • Alzheimer's Disease Video Animation • Angioplasty • Coronary Bypass Surgery • Erectile Dysfunction More... Related Drug Information • Accupril • Actonel • Altace • Avapro More... Related News Articles • Extra Pounds During and Between Pregnancies Can Pose Problems • Health Tip: Talking to a Person With Alzheimer's Disease • Talk Therapy Proves Effective for Terminal Cancer Patients • Muscle Mass May Not Explain High Creatinine in Black Kidney Patients More...

Page:  << Prev | 1 | 2 | 3 | Next >>

Another strong critic, Dr. Eric J. Topol, director of the Scripps Translational Science Institute, also found fault with the new drug. Topol first published data on the danger of Vioxx in 2001.

"We don't have the data to know the boundaries of Arcoxia's safety," he said in an interview in April, before the advisory panel's vote. "There is a difference now that there is awareness of heart risk with these drugs. There was not awareness, in fact, there was denial back in 2001."

"If the drug is approved, it would not be the same as what happened years ago," he added. "But I still am concerned that we don't have the cardiovascular safety issue assured. There can be misrepresentation of the drug when it's marketed."

Text Continues Below

---

A top Merck official told the advisory panel that the company has "comprehensively characterized the safety and efficacy profile" of Arcoxia.

"We at Merck believe etoricoxib represents a valuable treatment option for patients with osteoarthritis. We would like to emphasize there is more long-term safety data ... for etoricoxib than any other NSAID," said Peter Kim, president of Merck's research laboratories.

But other experts were not convinced.

In prepared testimony for the panel, Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, said the drug should not be approved in the United States and should be pulled from the market in the more than 60 countries where it is now sold.

"How can the approval of etoricoxib and the large numbers of preventable, life-threatening cardiovascular adverse reactions be justified?" Wolfe said in a prepared statement. "Why should the similarly dangerous offspring of Vioxx be approved? The answer is that it should not."

Wolfe noted that trial data presented by Merck on cardiovascular risks compared etoricoxib with the arthritis pain reliever diclofenac (brand name Voltaren), which he said is much more cardio-toxic than older, safer pain relievers.

Page:  << Prev | 1 | 2 | 3 | Next >>