Navigation Links
Arcoxia Slammed –Nothing Better Than Vioxx Says FD

Drug giant Merck is in trouble again. The Federal Drug Administration of U.S (FDA) has rejected its proposed successor(Arcoxia) to the drug Vioxx, //that was pulled out of the market due to safety reasons.

The arthritis drug Arcoxia which belongs to the same class of drugs as Vioxx ,was voted out 20-1 by an advisory panel two weeks back.

Merck pulled Vioxx from the market in September 2004 after research showed that it doubled the risk of heart attacks and strokes. This move triggered an avalanche of lawsuits and a nosedive for Merck's stock prices.

Yet, despite safety concerns in the United States, Arcoxia is still on sale in 63 other countries. Merck officials have confirmed that they intend to keep working to get it on the U.S. market.

These drugs are meant for the treatment of arthritic diseases. Osteoarthritis is a joint disease that mostly affects cartilage, 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. These newly developed drugs for treatment of inflammation selectively block an enzyme called COX-2. Blocking this enzyme blocks the production of the chemical messengers (prostaglandins) that cause the pain and swelling resulting from arthritis inflammation.

Though they are supposed to be gentler on the stomach, making it easier for patients than traditional pain relievers, one has to contend with serious side effects. Dr. David Graham, a leading critic of the now withdrawn Vioxx, told the panel that Arcoxia might increase the risk of stroke and heart attack and was no more effective for pain relief than other medicines in the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. Yet 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, says 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, says Scott Korn, Merck's executive director of regulatory affairs.

Yet 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.

Says Martha Solanche, a consumer representative on the advisory panel: “The idea should not be that we need new drugs. The idea should be that we need better drugs.”


ANN/
'"/>




Related medicine news :

1. Mercks Pain Reliever Arcoxia Rejected by US Federal Advisory Panel
2. Warrior Gene Claims Slammed by Maori
3. Cereal Bars Slammed for More Sugar Than Sweet Snacks
4. Better prostate cancer detection
5. Better Treatment for obesity
6. For a Better Memory
7. Baby Talk Better Than Adult Speech
8. Drug Combo Works Better for children with ADHD, Tics
9. Better skin with lasers
10. Better diabetes treatment promises Vanadium
11. Better Prostate Cancer Test
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:6/24/2016)... ... ... a crisis. Her son James, eight, was out of control. Prone to extreme mood shifts ... upset him, he couldn’t control his emotions,” remembers Marcy. “If there was a knife ... and say he was going to kill them. If we were driving on the ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA is excited ... To Recovery® program to drive cancer patients to and from their cancer treatments. ... highest quality of life and ongoing independence. Getting to and from medical treatments ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... ... Living, is proud to recognize Dr. Barry M. Weintraub as a prominent plastic ... most beautiful women in the world, and the most handsome men, look naturally ...
(Date:6/24/2016)... ... June 24, 2016 , ... Venture Construction Group (VCG) sponsors ... on June 20th at the Woodmont Country Club at 1201 Rockville Pike, Rockville, Maryland, ... to helping service members that have been wounded in battle and their families. Venture ...
(Date:6/24/2016)... ... 24, 2016 , ... To succeed under value-based payments, healthcare ... unsure how to move forward, given the need to sustain current operations. PYA ... to an organization’s specific needs. , PYA Principal Martie Ross states, “Healthcare providers ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... -- Research and Markets has announced the addition ... - Forecast to 2022" report to their offering. ... to date financial data derived from varied research sources to ... potential impact on the market during the next five years, ... of sub markets, regional and country level analysis. The report ...
(Date:6/23/2016)... Research and Markets has announced the addition of ... their offering. The current ... environment for MedImmune to enter. The US ageing population creates ... drive considerable growth for effective anti-influenza medications. The introduction of ... but development is still in its infancy. ...
(Date:6/23/2016)... , , , WHEN: ... , , , , LOCATION: , , , Online, with ... , EXPERT PANELISTS:  , , , Frost & Sullivan,s Global Vice ... Senior Industry Analyst, Divyaa Ravishankar and Unmesh Lal, Program Manager , ... industry is witnessing an exceptional era. Several new demand spaces, such ...
Breaking Medicine Technology: