Vioxx Pulled From Global Market

Friday, October 1st 2004

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Merck & Co., Inc., announced today a voluntary withdrawal of rofecoxib (Vioxx) from the U.S. and worldwide market due to safety concerns of an increased risk of cardiovascular events, according to an alert from MedWatch, the U.S. Food and Drug Administration (FDA) safety information and adverse event reporting program.

Rofecoxib is a cyclooxygenase 2-selective, nonsteroidal anti-inflammatory drug (NSAID) that was approved by FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms, and was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children.

On Sept. 27, the data safety monitoring board for an ongoing long-term study of rofecoxib (APPROVe) recommended that the study be stopped early for safety reasons. The study showed an increased risk of cardiovascular events, including heart attack and stroke, in patients receiving rofecoxib compared with placebo, particularly those who had been taking the drug for longer than 18 months. Based on this new safety information, Merck and FDA officials met the next day, and during that meeting, the FDA was informed that Merck was voluntarily withdrawing rofecoxib from the market.

"Merck did the right thing by promptly reporting these findings to FDA and voluntarily withdrawing the product from the market," Acting FDA Commissioner Dr. Lester M. Crawford says in an FDA news release. "Although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that, overall, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo."

According to an FDA public health advisory, patients who are currently taking rofecoxib should contact their physician for guidance regarding discontinuation and alternative therapies.

Dr. Crawford added that the FDA will closely monitor other drugs in this class for similar adverse effects. "All of the NSAID[s] have risks when taken chronically, especially of gastrointestinal bleeding, but also liver and kidney toxicity. They should only be used continuously under the supervision of a physician."

Footnote from Ideal Health

The following natural products are all useful for Joint Problems:

Bee Venom with Glucosamine
Boswellia
Complete Omega 3.6.9
Deer Velvet
Devils Claw Secondary Root
Efamarine
Glucosamine 1-A-Day
Hi Strength Liquid Fish Oil
Injuraid
Joint Connection
Joint Repair Liquid
Joint Vitality
MSM
Pain Relief
Quercetin with Bromelain
Turmeric

Related health information can be found here:

Arthritis & Rheumatism
The Arthritis Program
Bee Venom and Glucosamine
Chondroitin
Glucosamine - arthritis, joint pain / swelling
Rheumatism
Tired and Lacking Energy?

Related articles can be found here:

Arthritis studies focus on Boswellia
Boswellia - rediscovering a powerful anti-inflammatory herb
Good news for sufferers of Osteoarthritis
Landmark clinical trail: Great news for Arthritis Sufferers
Pharmalert - VIOXX Withdrawal
Osteoarthritis is repairable
Research on Rheumatoid Arthritis
Study finds natural alternative may ease pain for arthrits sufferers

If you need help or advice, you are welcome to email our naturopathic team with your health question.

Disclaimer: The health information presented here has been written for the New Zealand health consumer. It is of a general nature and is only intended to provide a summary of the subjects covered. The information is not intended to be comprehensive or to provide medical advice to you. While all care has been taken to ensure the accuracy of the information, no responsibility or liability is accepted, and no person should act in reliance on any statement contained in the information provided. All health ailments should be treated by a qualified health professional.

 

 

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