Find Information About:

Drugs & Supplements

Get information and reviews on prescription drugs, over-the-counter medications, vitamins, and supplements. Search by name or medical condition.

Pill Identifier

Pill Identifier

Having trouble identifying your pills?

Enter the shape, color, or imprint of your prescription or OTC drug. Our pill identification tool will display pictures that you can compare to your pill.

Get Started
My Medicine

My Medicine

Save your medicine, check interactions, sign up for FDA alerts, create family profiles and more.

Get Started

WebMD Health Experts and Community

Talk to health experts and other people like you in WebMD's Communities. It's a safe forum where you can create or participate in support groups and discussions about health topics that interest you.

  • Second Opinion

    Second Opinion

    Read expert perspectives on popular health topics.

  • Community


    Connect with people like you, and get expert guidance on living a healthy life.

Got a health question? Get answers provided by leading organizations, doctors, and experts.

Get Answers

Sign up to receive WebMD's award-winning content delivered to your inbox.

Sign Up

Pain Management Health Center

Font Size

FDA Panel Rejects Vioxx-Like Pain Drug

Experts Raise Concerns About Potential Safety Issues of Arcoxia
WebMD Health News
Reviewed by Louise Chang, MD

April 12, 2007 -- A federal advisory panel on Thursday rejected Merck's bid to market a new osteoarthritis medication similar to Vioxx, a drug the company pulled from the U.S. market in 2004 because it put patients at risk for heart attacks and strokes.

The decision, delivered in a 20 to 1 vote, makes it highly unlikely that the FDA will approve the drug, called Arcoxia.

Arcoxia is in the class of nonsteroidal anti-inflammatory drugs (NSAIDs) known as Cox-2 inhibitors, which includes Vioxx and Bextra -- both removed from U.S. pharmacies -- as well as Celebrex, which is still on the market. Cox-2 drugs have a lower risk for stomach ulcers and gastrointestinal bleeding than other NSAIDs such as aspirin and ibuprofen.

Arcoxia has been sold for the last five years in Europe and in dozens of countries around the world. The drug represented Merck's first attempt to return to the once-lucrative Cox-2 pain drug market in the U.S.

The company had hoped to convince experts that the drug was a better pain drug than related drugs -- and also that it was safer.

"Patients with osteoarthritis want and deserve additional treatment options," said Scott Korn, MD, Merck's executive director of regulatory affairs.

But experts and some FDA officials criticized Merck for using poorly designed scientific studies in an attempt to put Arcoxia in the best possible light.

Panel member David Felson, MD, noted that more than roughly 20 nonsteroidal anti-inflammatory drugs are already on the market.

"A new drug has to have some reason why you would put it in the top six of your rotation or it's not going to have much of an effect," said Felson, a professor of medicine at the Boston University School of Medicine.

After hearing Merck's results, Felson said he'd concluded that "20 is enough."

Robert Shibuya, an FDA medical officer, told experts that studies in nearly 4,000 patients left "little doubt" that Arcoxia is an effective pain reliever. But in question was the drug's potential, like similar drugs, to increase risk for cardiovascular problems like heart attacks and stroke in millions of potential users.

Today on WebMD

pain in brain and nerves
Top causes and how to find relief.
knee exercise
8 exercises for less knee pain.
acupuncture needles in woman's back
How it helps arthritis, migraines, and dental pain.
chronic pain
Get personalized tips to reduce discomfort.
illustration of nerves in hand
lumbar spine
Woman opening window
Man holding handful of pills
Woman shopping for vegetables
Sore feet with high heel shoes
acupuncture needles in woman's back
man with a migraine