James F. Humphreys & Associates
Practice Area Quick Menu
Practice Areas
- Personal Injury/Wrongful Death
- Product Liability
- Defective Pharmaceuticals
- Environmental Litigation
- Mesothelioma
- Railroaders
- Employment Law
- Securities
- Occupational Disease
- Insurance/Financial Bad Faith
Latest News
- New Hampshire Woman First of Her State to File Vioxx Lawsuit
- Merck & Co. Changes Tune
- FDA Opens Hearings on Arthritis Drugs
Have you or a loved one been a victim of ...
Practice Area Attorneys
We are a Top Legal firm that can provide you all the services and resources to win your case.
Press
FDA OPENS HEARINGS ON ARTHRITIS DRUGS
The Associated Press
February 16, 2005
The Food and Drug Administration promised prompt action Wednesday on recommendations from advisory committees probing the safety of popular painkillers, but urged the advisers to balance the risks and benefits of the drugs.
Vioxx was pulled from the market Sept. 30 after a long-term clinical trial indicated some patients suffered heart attacks or strokes. Similar safety questions have risen concerning the related drugs Celebrex and Bextra.
The advisory committees are hearing from government officials, physicians, researchers and the public in three days of meetings before voting on recommendations for these prescription drugs, known as Cox-2 inhibitors.
Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, said the agency will act rapidly _ in the next few weeks _ on the committee recommendations. The FDA is not required to accept such recommendations, but generally does.
Galson reminded the group that the drugs in question are important painkillers widely used by people in chronic pain. It is important to balance the risks of drugs with their benefits, he said.
A drug that has a positive risk-benefit balance for the population as a whole, Galson added, may still cause serious problems for some individuals.
The FDA has been criticized for being slow to recognize problems with these drugs.
However, committee chairman Dr. Alistair J. Wood of Vanderbilt University stressed as he opened the session that the committee "is not here to delegate blame or revisit the past."
Vioxx was withdrawn by its manufacturer, Merck & Co. Celebrex and Bextra , made by Pfizer Inc., remain on the market.
The editor of a leading medical journal has questioned whether patients should continue using the drugs.
"Because there are well-established options for treatment of all the approved indications for these drugs, it is reasonable to ask whether the use of the drugs can now be justified," Dr. Jeffrey M. Drazen, editor of the New England Journal of Medicine, said in an editorial published online Tuesday.
In calling the advisory committee hearing Wednesday, the FDA's Center for Drug Evaluation and Research noted that many consumers and scientists have asked whether any Cox-2 drugs should be allowed to remain on sale.
The Health and Human Services Department announced Tuesday that the FDA will establish a new Drug Safety Oversight Board to monitor medicines once they're on the market and will update physicians and patients with emerging information on risks and benefits.
Dr. Mark Fendrick, an internal medicine specialist at the University of Michigan , said the decision on using the drugs "should be considered one of competing risk and benefits."
"It comes down to the individual and his or her clinician to assess the risks and make the best informed choice," Fendrick said. "Until we know for sure about the cardiological safety of the Cox-2 inhibitors, I believe they should be limited to those individuals who have a risk of stomach injury and those who are at low risk for cardiac problems."
People who have a heart risk or who take aspirin to protect the heart should consider a traditional painkiller, he said.
Many people who take the Cox-2 drugs to avoid stomach problems also take aspirin to protect the heart, he noted, which cancels the gastrointestinal protection of the Cox-2 drugs.
The advisers will also be trying to determine what it is about these drugs that could cause an increase in heart problems.
On Monday, a paper in the journal Archives of Internal Medicine reported on a new analysis that indicates Cox-2 inhibitors raise blood pressure more than conventional pain medications.
A second possibility is that Vioxx directly affects endothelial cells, which line the heart and blood vessels.
A 1999 study of Alzheimer's patients taking Celebrex indicated the patients had four times the risk of heart problems. Pfizer contends that definitive conclusions cannot be drawn from that study. In December, a different study linked Celebrex to increased cardiovascular problems. The company said the results in that study were not consistent with a data the company had collected.