An advisory panel of the United States Food and Drug Administration (FDA) has rejected pharmaceutical giant Merck's bid to market Arcoxia,// a new osteoarthritis medication following concerns that it may carry cardiovascular risks.
Osteoarthritis is a joint disease that mostly affects cartilage. Cartilage is the slippery tissue that covers the ends of bones in a joint.
While healthy cartilage allows bones to glide over each other and helps absorb shock of movement, in osteoarthritis, the top layer of cartilage breaks down and wears away.
This allows bones under the cartilage to rub together. The rubbing causes pain, swelling, and loss of motion of the joint.
Merck's Arcoxia is in the class of non-steroidal anti-inflammatory drugs (NSAIDs) known as COX-2 inhibitors.
It had to pull yet another CoX-2 inhibitor Vioxx from the US market in 2004, also following evidence that it increased the patients' risk of heart attacks and strokes.
G.D.Searle and Company too withdrew a COX-2 inhibitor, Bextra because of similar concerns.
These newly developed drugs for treatment of inflammation selectively block an enzyme called COX-2. Blocking this enzyme impedes the production of the chemical messengers (prostaglandins) that cause the pain and swelling resulting from arthritis inflammation.
And they are supposed to be gentler on the stomach, making it easier for patients than traditional pain relievers. But then one has to contend with serious side-effects.
The FDA advisory panel on Thursday rejected by a 20-to-1 margin the Merck's new formulation, Arcoxia.
"We got what appears to be a very clear vote advising us against approval," said Robert Meyer, director of FDA's office of drug evaluation.
Dr. David Graham, a leading critic of the now withdrawn Vioxx, told the panel that Arcoxia might increase substantially the risk of stroke and heart attack and was no more ePage: 1 2 Related medicine news :1
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