|
From the 2006 Drug Guide
Following the sudden withdrawal of Vioxx from the market in September 2004, calls and letters began pouring in from Arthritis Today readers. Some applauded Merck's decision to withdraw a dangerous drug. Some were emphatic that they and their doctors—not a drug company or the FDA—should be responsible for deciding if the drug's risks were too great. Still others just wanted to know how or if they might be able to continue getting the only drug that had helped their pain without upsetting their stomach.
The following February, the FDA convened an advisory committee to make recommendations as to whether the two remaining COX-2 inhibitors, celecoxib (Celebrex) and valdecoxib (Bextra), should be pulled from the market.
The advisory committee concluded unanimously that COX-2 drugs increase the risk of heart attacks and strokes, and that the drugs' labels—as well as labels for all NSAIDs—should carry strong warnings about the risks. But the majority voted for keeping all three drugs—including the previously pulled Vioxx—on the market, stating that for many people the benefits of the drugs (relief from pain and inflammation with reduced risk of stomach ulcers) outweighed the cardiovascular risks.
While the label changes have taken effect (and are reflected in this year's Drug Guide), Vioxx has not returned to the market. And last April, valdecoxib (Bextra) was removed from the market by its manufacturer, Pfizer, upon request of the FDA. Data showed that people taking Bextra for postoperative pain following coronary artery bypass surgery had two to three times the risk of heart attack, cardiac arrest, stroke or blood clots. That evidence—combined with the fact that Bextra carries risk for a rare but potentially life-threatening skin reaction and has not proven to be safer for the gastrointestinal system than the other COX-2s—led the FDA to request its withdrawal.
For many people, the benefits of Bextra or Vioxx are worth the risks, however. More than a year after the Vioxx withdrawal, readers continue to ask when and if they might get their medications. No one knows yet, but there have been hints of progress in that direction.
In Canada, health authorities have expressed some interest in approving the resumption of Vioxx sales. In June, an advisory panel to Health Canada, the Canadian equivalent of the FDA, reported that the available data on Vioxx justifies the marketing of the drug in Canada—provided the manufacturer submits a new drug application to be reviewed and approved by the agency. The FDA, too, has said it will carefully review any proposal from Merck for resuming the marketing of Vioxx and would likely discuss the review with the new FDA Drug Safety Oversight Board, which is charged with managing the flow of emerging drug safety information.
"We are at a similar point in time with both [the FDA and Health Canada]," says Merck spokesperson Guy Bizzoco. Advisory panels in both countries made a recommendation to return Vioxx to the market, but to date there have been no decisions as to when or if this will actually happen. "At this point, Merck is continuing discussions with the FDA," says Bizzoco.
Though the return of Bextra is not expected, its manufacturer, Pfizer, will work with the FDA to explore how the drug could be made available on a compassionate use basis, says Jeanne Traflet, a Pfizer spokesperson.
"If the [manufacturer] proposes a program to provide limited access to patients who believe Bextra
is the best drug for them, the FDA would be willing to consider this," says Joan
Powers, an FDA spokesperson. While it may take some time to work out such a
program, Pfizer is taking names of people who would be interested in receiving
the drug when and if a compassionate use program is available.
 |
Get your own copy of the 2007 Drug Guide
featured in the 20th Anniversary issue of Arthritis Today magazine.
The consumer health magazine published by the Arthritis Foundation six times a year.
Order your FREE trial issue today!
|
| 
Back to Drug Guide Home