Navigation Links
Merck's Pain Reliever Arcoxia Rejected by US Federal Advisory Panel

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 David Graham, a leading critic of the now withdrawn Vioxx, told the panel that Arcoxia might increase substantially the risk of stroke and heart attack and was no more e ffective for pain relief than other medicines in the same class. "What you're talking about is a potential public health disaster," he said.

COX-2 drugs have never been shown to be better pain relievers than older NSAIDs like ibuprofen. But doctors eagerly prescribed them in part because they tend to cause fewer ulcers and less gastrointestinal bleeding.

There is nothing special about this drug that would warrant giving it to patients and putting them at risk of cardiovascular death, said Dr.David Felson, a professor of medicine at the Boston University School of Medicine and a member of the advisory panel.

Arcoxia has been sold for the past five years in Europe and in dozens of other countries around the world. The drug represented Merck's first bid to return to the once-lucrative COX-2 pain drug market in the United States.

The company had hoped to convince experts that the drug was a safer and more effective pain reliever than related drugs.

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

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

Bruce Psaty, director of the cardiovascular health research unit at the University of Washington, says manufacturers can "rig" trials by comparing their drug to one known to be relatively weak. "It makes their drug look good or comparable but doesn't provide much in useful public health information," he says.

More than 20 NSAIDs were already on the U.S. market, it has been pointed out.

The idea should not be that we need new drugs. The idea should be that we need better drugs, said Martha Solanche, a consumer representative on the advisory panel.
GPL
'"/>




Related medicine news :

1. Acid Test - Glaxos Cervarix, and Mercks Gardasil, Compete
2. Ranbaxy in Fray to Buy Mercks Generic Drugs Unit
3. The Effect Of Pain Relievers In Treating Kids With Migraine Questioned
4. Hypnotherapy can be a Pain Reliever
5. FDA Proposes Stringent Warnings Labels for Pain Relievers
6. Arcoxia Slammed –Nothing Better Than Vioxx Says FD
7. Testosterone patch for women Rejected For safety Reasons
8. Federal Government Has to do a lot to prevent spread of HIV
9. New Study Conducted To Evaluate The Success Of The Federal governments Funds For HIV/AIDS
10. Sunscreen Blocking UVA Radiation Receives Federal Approval
11. Imperative to Extend Reach of Federal Health Insurance Schemes for children
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:10/13/2017)... Calif. (PRWEB) , ... October 13, 2017 , ... Many ... dementia. However, many long-term care insurance companies have a waiver for care if the ... 90-day elimination period, when the family pays for care, is often waived, so the ...
(Date:10/13/2017)... ... 2017 , ... Ellevate Network, the leading network for professional women, brought together ... equality at their inaugural Summit in New York City in June. The event was ... of over 3 million. To watch the Mobilize Women video, click here . ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Yisrayl Hawkins, Pastor ... that explains one of the most popular and least understood books in the Holy ... and puzzling descriptions that have baffled scholars for centuries. Many have tossed it off ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a leader in ... awarded a contract by the Center for Medicare and Medicaid Services (CMS). The ... enterprise use of Agile methodologies in a consistent and high value manner across ...
(Date:10/13/2017)... ... ... On The Brink”: the Christian history of the United States and the loss of ... William Nowers. Captain Nowers and his wife, Millie, have six children, ten grandchildren, ... Navy. Following his career as a naval aviator and carrier pilot, he spent ...
Breaking Medicine News(10 mins):
(Date:9/18/2017)... , Sept. 18, 2017  PMD Healthcare of ... Pharmacy of Kalamazoo, Mich. , have ... service that expedites and streamlines patient and provider access ... 2.0, and wellness management services.  ... used to measure lung function for a variety of ...
(Date:9/12/2017)... and NEW YORK , Sept. 12, 2017 ... performance ratings for global supply chains, has published the first annual edition ... CSR performance of more than 20,400 companies evaluated by EcoVadis, based on ... 2015 and 2016. ... EcoVadis Global CSR Risk & Performance Index ...
(Date:9/9/2017)... -- ... Washington DC ... 12 th – Monday, September 18 th .The Brain Tumor Foundation ... scans to the public.Where:  BTF,s Mobile MRI Unit ... Street NW, Washington, D.C.What:BTF brings its nationwide initiative, the Road to Early ...
Breaking Medicine Technology: